Bioness NESS L300 Plus User manual

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
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
602-00383-001 Rev. C
Rx Only

Clinician’s Guide

I
Clinician’s Guide
Rx Only

II Clinician’s Guide
Clinician’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 and its affiliates do 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.
When the life cycle of the NESS L300 Plus System has been completed, the product should be discarded
according to the laws and regulations of the local authority. For more detailed information regarding
these recommended procedures, please contact Bioness Inc. Bioness Inc is committed to continuously
seeking and implementing the best possible manufacturing procedures and servicing routines.
Worldwide Corporate Office
Bioness Inc
25103 Rye Canyon Loop
Valencia, CA 91355 USA
Telephone: [phone]
Email: [email protected]
Website: www.bioness.com
Manufactured by
Bioness Neuromodulation Ltd.
A Bioness Inc Company
19 Ha’Haroshet Street
PO Box 2500
Industrial Zone
Ra’Anana 43654, Israel
Bioness Client Relations Department: Telephone: [phone], Option 2; or [phone], Option 2.

III
Table of Contents
List of Symbols ........................................................................................................................................... IX
Chapter 1: Introduction ........................................................................................................ 1
Chapter 2: Device Description and Safety Information ........................................................ 3
Device Description........................................................................................................................................3
Indications for Use........................................................................................................................................3
Contraindications..........................................................................................................................................4
Warnings ......................................................................................................................................................4
Precautions...................................................................................................................................................4
Adverse Reactions .......................................................................................................................................6
Skin Care Guidelines....................................................................................................................................7
Chapter 3: Environmental Conditions that Affect Use.......................................................... 9
Radio Frequency (RF) Communication Information ..................................................................................... 9
Travel and Airport Security .........................................................................................................................10
Electromagnetic Emissions ........................................................................................................................ 11
Warnings .............................................................................................................................................. 11
Chapter 4: The NESS L300 Plus System............................................................................. 13
L300 FS Cuff ..............................................................................................................................................14
L300 RF Stim Unit................................................................................................................................16
Cradle ..................................................................................................................................................18
Locator .................................................................................................................................................18
Strap ....................................................................................................................................................19
Liner .....................................................................................................................................................19
Electrode Options ................................................................................................................................20
Large Cloth Electrode, L300 Systems ...........................................................................................20
L300 Hydrogel Electrodes and Bases ...........................................................................................21
L300 Cloth Electrodes and Bases .................................................................................................22
Thigh FS Cuff .............................................................................................................................................23
Proximal and Distal Panels ..................................................................................................................25
Elongation Bar .....................................................................................................................................25
Thigh RF Stim Unit...............................................................................................................................26
Cradle ..................................................................................................................................................28
Thigh Clinic Straps...............................................................................................................................28

IV Clinician’s Guide
Thigh Cloth Electrodes.........................................................................................................................29
Locator .................................................................................................................................................29
Intelli-Sense Gait Sensor............................................................................................................................30
L300 Plus Control Unit................................................................................................................................31
Operating Buttons ................................................................................................................................31
Turning On/Off the NESS L300 Plus System.......................................................................................32
Testing the Position of the FS Cuffs.....................................................................................................32
L300 FS Cuff .................................................................................................................................32
Thigh FS Cuff ................................................................................................................................33
Selecting an Operating Mode ..............................................................................................................33
Gait Mode ......................................................................................................................................33
Training Mode................................................................................................................................33
Standby Mode ...............................................................................................................................34
Clinician Mode ...............................................................................................................................34
Adjusting Stimulation Intensity .............................................................................................................35
L300 FS Cuff .................................................................................................................................35
Thigh FS Cuff ................................................................................................................................35
Muting/Un-Muting the Control Unit.......................................................................................................35
Muting the RF Stim Units ....................................................................................................................35
Turning On Audio Feedback During Stimulation ..................................................................................36
L300 FS Cuff .................................................................................................................................36
Thigh FS Cuff ................................................................................................................................36
Turning Off Audio Feedback During Stimulation ..................................................................................36
Digital Display and Indicator Lights......................................................................................................37
Chapter 5: Clinician’s Components and Accessories......................................................... 41
L300 Clinician’s Kit .....................................................................................................................................41
PDA Components ................................................................................................................................41
Accessories..........................................................................................................................................41
L300 Plus Clinician’s Pack w/Software.......................................................................................................41
Chapter 6: PDA Components and Setup ............................................................................. 43
HP iPAQ Clinician’s Programmer ...............................................................................................................43
On/Off Button .......................................................................................................................................44
Reset Button ........................................................................................................................................44
Charge Indicator Light..........................................................................................................................44

V
SD (Secure Digital) Slot .......................................................................................................................44
Battery..................................................................................................................................................44
Touchscreen Display............................................................................................................................44
Connector Port.....................................................................................................................................44
HP iPAQ Configuration Cradle with Stylus .................................................................................................45
HP iPAQ Clinician’s Programmer Charger .................................................................................................45
Programming Setup....................................................................................................................................46
Chapter 7: NESS L300 Plus Intelli-Gait Software................................................................ 49
Icons, Menus, Buttons, Tabs, and Data Entry ............................................................................................49
Information Icon ...................................................................................................................................49
Advanced Settings and Audio Feedback Icons....................................................................................50
Back Icon .............................................................................................................................................50
Menus ..................................................................................................................................................51
Buttons.................................................................................................................................................53
L300 and Thigh Tabs............................................................................................................................54
Scroll Bars............................................................................................................................................55
Keyboard..............................................................................................................................................56
Drop-Down Lists ..................................................................................................................................56
Programming the NESS L300 Plus System ...............................................................................................57
Logging In ............................................................................................................................................57
Connecting the L300 Plus Control Unit................................................................................................58
New Patient Detected....................................................................................................................58
Control Unit Unassigned................................................................................................................59
L300 Plus Control Unit Not Registered..........................................................................................59
Non-Supported System Detected..................................................................................................59
Thigh RF Stim Unit Not Detected ..................................................................................................60
Data Inconsistency ........................................................................................................................60
Opening/Creating a Patient Record .....................................................................................................61
Selecting a System Configuration........................................................................................................62
Programming the L300 ........................................................................................................................63
Stim Settings .................................................................................................................................63
Advanced Stim Settings ................................................................................................................ 64
Increased Charge....................................................................................................................64
Gait Settings ..................................................................................................................................66

VI Clinician’s Guide
Advanced Gait Settings .................................................................................................................67
Maximum Duration of Stimulation ...........................................................................................67
Programming the Thigh........................................................................................................................68
Stim Settings .................................................................................................................................68
Gait Settings, Thigh Hamstrings....................................................................................................69
Advanced Gait Settings, Thigh Hamstrings...................................................................................71
Maximum Duration of Stimulation ...........................................................................................72
Gait Settings, Thigh Quadriceps....................................................................................................73
Advanced Gait Settings, Thigh Quadriceps...................................................................................74
Programming Training Settings............................................................................................................ 75
Viewing a Patient's History...................................................................................................................77
Session History..............................................................................................................................77
Gait Log .........................................................................................................................................79
Training Log...................................................................................................................................81
Managing Patient Records...................................................................................................................83
Modifying a Patient Name ............................................................................................................. 83
Removing a Patient Record...........................................................................................................84
Viewing the System Information...........................................................................................................85
Managing Users...................................................................................................................................86
Adding a User................................................................................................................................86
Removing a User...........................................................................................................................87
Changing a User Password...........................................................................................................87
Backing Up and Restoring the Database.............................................................................................88
Automatic Backup..........................................................................................................................88
Manual Backup..............................................................................................................................88
Restore ..........................................................................................................................................89
Chapter 8: Fitting the NESS L300 Plus System ................................................................. 91
Skin Preparation.........................................................................................................................................91
L300 FS Cuff ..............................................................................................................................................91
Measuring for FS Cuff Strap Size ........................................................................................................91
Attaching the Personal Strap Cover.....................................................................................................92
Attaching the Personal Panel...............................................................................................................93
Attaching the Large Cloth Electrode, L300 Systems ...........................................................................93
Attaching the L300 Hydrogel Electrodes and Bases............................................................................96

VII
Placing the Hydrogel Electrodes and Bases on the Leg ............................................................... 96
Connecting the Fitting Cable .........................................................................................................98
Adjusting the Position of the Electrodes: Patient Seated .............................................................. 99
Adjusting the Position of the Electrodes: Patient Standing............................................................99
Transferring the Electrodes to the L300 FS Cuff .........................................................................100
Donning the L300 FS Cuff..................................................................................................................101
Retesting Electrode Placement: Patient Sitting and Standing ...........................................................103
Attaching the L300 Cloth Electrodes and Bases................................................................................103
L300 Cloth Electrode Bases ........................................................................................................104
L300 Cloth Electrodes .................................................................................................................106
Attaching the Wire Concealers ..........................................................................................................108
Thigh FS Cuff ...........................................................................................................................................109
Measuring for Thigh FS Cuff Size ......................................................................................................109
Adjusting the Elongation Bar.............................................................................................................. 110
Attaching the Thigh Cloth Electrodes................................................................................................. 111
Donning the Thigh FS Cuff................................................................................................................. 115
Checking the Position of the Thigh Cloth Electrodes: Patient Seated ............................................... 116
Checking the Position of the Thigh Cloth Electrodes: Patient Standing............................................. 117
Programming Gait Settings ...................................................................................................................... 117
Placing the Gait Sensor in the Shoe .................................................................................................. 117
Programming Training Settings ................................................................................................................ 119
Doffing the NESS L300 Plus System ....................................................................................................... 119
Attaching the Thigh Electrode Marking Ring ...............................................................................120
Chapter 9: Patient Training and Follow-Up....................................................................... 121
Chapter 10: Maintenance and Cleaning ............................................................................ 123
Registering an L300 Plus System Upgrade Kit ........................................................................................123
Registration Setup .............................................................................................................................123
Registration........................................................................................................................................124
Charging...................................................................................................................................................126
PDA Battery Storage ................................................................................................................................126
Battery Replacement................................................................................................................................126
Electrodes.................................................................................................................................................126
Electrode Bases .......................................................................................................................................127
FS Cuffs....................................................................................................................................................127

VIII Clinician’s Guide
Thigh Cuff Buckles ...................................................................................................................................128
Thigh Clinic Straps ...................................................................................................................................129
Thigh Silicone Panels...............................................................................................................................129
Thigh Elongation Bar Lock .......................................................................................................................130
Cleaning ...................................................................................................................................................131
Disinfecting...............................................................................................................................................131
Chapter 11: Troubleshooting ............................................................................................ 133
Using the Tester........................................................................................................................................133
Testing the L300 FS Cuff in Training Mode ........................................................................................133
Testing the L300 FS Cuff in Gait Mode ..............................................................................................134
Advanced Testing...............................................................................................................................134
Testing the Thigh FS Cuff in Training Mode.......................................................................................136
Testing the Thigh FS Cuff in Gait Mode .............................................................................................136
Advanced Testing...............................................................................................................................137
Frequently Asked Questions.....................................................................................................................139
Troubleshooting Quick Reference Table...................................................................................................145
Chapter 12: Technical Specifications ............................................................................... 147
Chapter 13: Appendix - EMI Tables................................................................................... 153

IX
Caution
Complies with United States and Canadian Product Safety Standards
Complies with the European Union Medical Device Directive
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
Single Patient Use
List of Symbols

XClinician’s Guide

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Chapter 1: Introduction
Introduction
Central nervous system (CNS) injuries and/or 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 Clinician’s Guide describes:
•The NESS L300 Plus System.
•The NESS L300 Plus Intelli-Gait Software.
•How to fit the NESS L300 Plus System.
•How to program the NESS L300 Plus System.
This guide also includes important safety instructions. Be sure to review the safety instructions
with patients before they use the NESS L300 Plus System.
If you have any questions, please call the Bioness Client Relations Department at
[phone], Option 3, or visit the Bioness website: www.bioness.com.

2Clinician’s Guide

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3
Chapter 2: Device Description and Safety Information
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—
delivers electrical pulses over the common peroneal nerve and to the motor point of the
tibialis anterior muscle. The L300 FS Cuff produces ankle dorsiflexion in the swing phase
of gait, to prevent foot drop.
•Thigh FS Cuff with Thigh RF Stim Unit—delivers electrical pulses:
•Over the tibial and common fibular (peroneal) portions of the sciatic nerve to stimulate
the hamstrings, to flex the knee.
•Over the femoral nerve to stimulate the quadriceps, to extend the knee.
•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 in functional and therapeutic modes.
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.

4Clinician’s Guide
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.
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.
•The Clinician’s Programmer should only contain the Windows Mobile for Pocket PC
operating system and Bioness Inc proprietary software. Third-party software packages
are not supported and may interfere with proper operation of the NESS L300 Plus System,
and void the warranty.
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. Advise patients to stop using the NESS
L300 Plus System until any inflammation is gone.
•Use caution when treating patients with suspected or diagnosed heart problems.
•Use caution with patients who have suspected or diagnosed epilepsy.
•Advise patients to use the L300 and Thigh FS Cuffs with caution:
•If the patient has 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.

5
Chapter 2: Device Description and Safety Information
•Specific physician clearance should be obtained before using the NESS L300 Plus
System on patients who have an alteration of normal arterial or venous flow in the region
of the L300 and/or Thigh FS Cuffs because of local insufficiency, occlusion, arteriovenous
fistula for the purpose of hemodialysis, or a primary disorder of the vasculature.
•Specific physician clearance should be obtained before using the NESS L300 Plus
System on patients who have a structural deformity in the area to be stimulated.
•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
are 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 changing 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. Use of the NESS L300
Plus System should be temporarily halted until any irritation is resolved completely.
•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 L300 and Thigh FS Cuffs are fastened
in place.
•Advise patients to turn off the NESS L300 Plus System before driving, operating
machinery, or performing any activity in which involuntary muscle contractions may put
the patient at undue risk of injury.
•Advise patients to turn off the NESS L300 Plus System when at a refueling place. They
should not use the NESS L300 Plus System near flammable fuel, fumes, or chemicals.
•Advise patients to stop using the NESS L300 Plus System and consult their clinician if
stimulation does not start at the correct time during gait.

6Clinician’s Guide
•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 (-13°F to +131°F). 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.
•Do not attempt to repair the 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 at [phone], Option 3, if you
experience a clinical or technical problem not covered in this guide.
Adverse Reactions
In the unlikely event that any of the following occurs, advise patients to stop using the
NESS L300 Plus System immediately and to consult their 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.

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Chapter 2: Device Description 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 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 that patients 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.
•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, advise patients to stop using the NESS L300 Plus
System immediately. They should contact their clinician or dermatologist, and the Bioness
Clinical Relations Department, Option 3. Patients should resume use of the L300 Plus System
only when the skin is completely healed, and then follow a skin-conditioning protocol per the
recommendation of a health-care specialist.
If you have any questions or concerns, please call the Bioness Client Relations
Department at [phone], Option 3.

8Clinician’s Guide