Bioness NESS L300 User manual

NESS
®
, NESS L300
®
, Intelli-Gait
®
, Intelli-Sense Gait Sensor
™
, Bioness, the Bioness Logo
®
and LiveOn
®
are
trademarks of Bioness Inc. | www.bioness.com
Rx Only
602-00156-001 Rev. G
01/2013
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

Clinician’s Guide

Clinician’s Guide
Rx Only

II
Clinician’s Guide Copyright
© 2006, Revised 2010, Bioness Inc
All Rights Reserved
No part of this publication may be reproduced, transmitted, transcribed, stored in a retrieval system, or translated
into any language or any computer language, in any form or by any third party, without the prior written permission
of Bioness Inc.
Trademarks
NESS®, NESS L300®, Intelli-Gait®, Intelli-Sense Gait Sensor™, Bioness, the Bioness Logo® and LiveOn® are
trademarks of Bioness Inc. | www.bioness.com
Patents Pending
Aspects of this device are covered by several patents and patent applications including US Pat 7,899,556.
Disclaimer
Bioness Inc and its affiliates shall not be liable for any injury or damage suffered by any person, either directly or
indirectly, as a result of the unauthorized use or repair of Bioness Inc products. Bioness Inc 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, 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 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.
Conformity Certification
The NESS L300 complies with the following standards:
Safety of Medical Equipment. General Requirements - UL 60601-1: 2003-04-25 (Ed.1) with Revisions up to
2003/06/30, and CSA C22.2 No.:601.1-1M90
Standard For Safety of Medical Equipment. Particular Requirements for Safety of Nerve and Muscle Stimulators -
IEC 60601-2-10:1987+A1:2001
European Authorized Representative
NESS Europe B.V.
Stationsweg 41
3331 LR Zwijndrecht, The Netherlands
Telephone: [phone]
Email: [email protected]
Website: www.bioness.com
Worldwide Corporate Office
Bioness Inc
25103 Rye Canyon Loop
Valencia, CA 91355 USA
Telephone: [phone]
Email: [email protected]
Website: www.bioness.com
Manufactured by
Bioness Neuromodulation Ltd.
A Bioness Inc Company
19 Ha’Haroshet Street
PO Box 2500
Industrial Zone
Ra’Anana 43654, Israel

III
Table of Contents
List of Symbols .......................................................................................................................................... VII
Chapter 1: Introduction ........................................................................................................ 1
Chapter 2: General Warnings and Precautions..................................................................... 3
Indications for Use ........................................................................................................................................3
Contraindications ..........................................................................................................................................3
Warnings ......................................................................................................................................................3
Precautions ...................................................................................................................................................4
Adverse Reactions .......................................................................................................................................5
Skin Care Guidelines ....................................................................................................................................6
Chapter 3: Environmental Conditions that Affect Use .......................................................... 7
Radio Communication Information ...............................................................................................................7
Travel .........................................................................................................................................................7
Chapter 4: The NESS L300 Foot Drop System ...................................................................... 9
Functional Stimulation (FS) Cuff .................................................................................................................10
Radio Frequency (RF) Stim Unit ................................................................................................................ 11
Intelli-Sense Gait Sensor ............................................................................................................................12
Control Unit .................................................................................................................................................13
Turning On/Off the Control Unit ...........................................................................................................15
Selecting Gait Mode .............................................................................................................................16
Selecting Training Mode ......................................................................................................................16
Returning to Standby Mode .................................................................................................................17
Selecting Clinician Mode ......................................................................................................................17
Fine-Tuning Stimulation Intensity .........................................................................................................18
Adjusting the Volume of the Audio Alerts .............................................................................................18
Turning On Audio Feedback During Stimulation .................................................................................. 19
System Safety Features .............................................................................................................................19
Chapter 5: The NESS L300 Clinician’s Kit .......................................................................... 21
Chapter 6: Programming Components and Software ......................................................... 25
Clinician’s Programmer ..............................................................................................................................25
On/Off Button .......................................................................................................................................25
Reset Button ........................................................................................................................................25
Charge Indicator Light ..........................................................................................................................25

IV
SD (Secure Digital) Slot ....................................................................................................................... 26
Battery ..................................................................................................................................................26
Touchscreen Display ............................................................................................................................26
Connector Port .....................................................................................................................................26
Configuration Cradle ...................................................................................................................................26
Storage Card ..............................................................................................................................................27
Clinician’s Programmer Charger ................................................................................................................27
Intelli-Gait Software ....................................................................................................................................27
Information Icon ...................................................................................................................................27
Navigation Menus ................................................................................................................................29
Navigation Buttons ...............................................................................................................................30
Keyboard ..............................................................................................................................................31
Drop-Down Lists ..................................................................................................................................31
Chapter 7: Fitting and Testing Accessories ....................................................................... 33
FS Cuff Straps ............................................................................................................................................33
Personal Strap Cover .................................................................................................................................34
Personal Panels .........................................................................................................................................35
Electrode Bases .........................................................................................................................................37
Electrodes ...................................................................................................................................................38
Wire Concealers .........................................................................................................................................40
Fitting Cable ...............................................................................................................................................40
Gait Sensor Pads .......................................................................................................................................41
Shoe Spacers .............................................................................................................................................41
L300 Tester .................................................................................................................................................42
Chapter 8: Set-Up: Clinician’s Programmer ........................................................................ 43
Connecting the Clinician’s Programmer and Configuration Cradle ............................................................ 43
Charging the Clinician’s Programmer .........................................................................................................43
Connecting the Control Unit and Clinician’s Programmer .......................................................................... 44
Chapter 9: Intelli-Gait Software Navigation ........................................................................ 45
User Login ..................................................................................................................................................45
Start-Up Message Screens ........................................................................................................................46
New Patient Message ..........................................................................................................................46
Unassigned Message ..........................................................................................................................46
Inconsistency Message ........................................................................................................................47

V
Patients Menu .............................................................................................................................................48
Creating a New Patient Record ...........................................................................................................48
Modifying a Patient Name ....................................................................................................................49
Removing a Patient Record .................................................................................................................49
Settings Menu .............................................................................................................................................50
Programming Stimulation Settings .......................................................................................................50
Programming Advanced Stimulation Settings ......................................................................................51
Programming Gait Settings ..................................................................................................................52
Programming Advanced Gait Settings ................................................................................................. 54
Programming Training Settings ............................................................................................................55
Programming Advanced Training Settings ...........................................................................................57
History Menu ..............................................................................................................................................58
Viewing a Session History ....................................................................................................................58
Removing a Session ............................................................................................................................58
Viewing the Gait Log ............................................................................................................................60
Viewing the Training Log ......................................................................................................................62
Admin Menu ...............................................................................................................................................64
Adding and Removing Users ...............................................................................................................65
Changing User Passwords ..................................................................................................................66
Backing Up the Database ....................................................................................................................67
Restoring the Database .......................................................................................................................68
Chapter 10: Fitting Guidelines ............................................................................................ 69
Inspect the Components .............................................................................................................................69
Attach the Hydrogel Electrodes and Electrode Bases ................................................................................70
Connect the Fitting Cable ...........................................................................................................................72
Adjust the Position of the Electrodes While Stimulating: Patient Seated ...................................................72
Test the Effect of a Positional Change .................................................................................................73
Adjust the Position of the Electrodes While Stimulating: Patient Standing .................................................73
Transfer the Electrodes to the FS Cuff .......................................................................................................73
Don the FS Cuff ..........................................................................................................................................76
Retest Electrode Placement: Patient Sitting and Standing .........................................................................76
Fitting the Small L300 Cloth Electrodes .....................................................................................................77
Fitting the Regular L300 Cloth Electrodes ..................................................................................................78
Fitting the L300 Quick Fit Electrodes ..........................................................................................................79

VI
Place the Intelli-Sense Gait Sensor in the Shoe .........................................................................................81
Program Gait, Training, and Advanced Settings .........................................................................................82
Doff the FS Cuff ..........................................................................................................................................83
Chapter 11: General Conditioning and Training Guidelines ............................................... 85
Acute/Subacute Patients ............................................................................................................................85
Gait Mode ............................................................................................................................................85
Training Mode ......................................................................................................................................85
Home Program Training .............................................................................................................................85
Standard Conditioning Protocol for NESS L300 Home Use .......................................................................86
Chapter 12: Patient Training and Follow-Up ....................................................................... 87
Patient Training ...........................................................................................................................................87
Patient Follow-Up .......................................................................................................................................88
Chapter 13: Care and Maintenance ..................................................................................... 89
Replacing the Intelli-Sense Gait Sensor Battery ........................................................................................89
Replacing the Clinician’s Programmer Battery ...........................................................................................89
Replacing the RF Stim Unit Battery ............................................................................................................90
Replacing the Control Unit Battery .............................................................................................................90
Replacing the L300 Quick Fit Electrode .....................................................................................................90
Replacing the L300 Cloth Electrodes .........................................................................................................92
Replacing the Regular L300 Hydrogel Electrodes ......................................................................................94
Replacing the Electrode Bases ..................................................................................................................96
Replacing the L300 FS Cuff .......................................................................................................................97
Electronically Registering New Components ..............................................................................................97
Chapter 14: Troubleshooting .............................................................................................. 99
Frequently Asked Questions .......................................................................................................................99
Using the L300 Tester ...............................................................................................................................105
Testing in Training Mode ....................................................................................................................105
Testing in Gait Mode ..........................................................................................................................105
Advanced Testing ...............................................................................................................................106
Troubleshooting Quick Reference Table ...................................................................................................108
Chapter 15: Technical Specifications ................................................................................111
Chapter 16: Appendix - EMI Tables ................................................................................... 117

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

VIII

1
Chapter 1: Introduction
Introduction
The NESS L300 Foot Drop System is an advanced neuroprosthesis designed to improve
gait in people suffering from foot drop―the dragging of the forefoot while walking—as a
result of a central nervous system injury or disease.
The NESS L300 Foot Drop System communicates wirelessly to deliver electrical pulses over
the common peroneal nerve and to the motor point of the tibialis anterior muscle, causing
ankle dorsiflexion in the swing phase of gait to prevent foot drop.
The NESS L300 Foot Drop System may facilitate muscle re-education, prevent disuse
atrophy of the muscles that dorsiflex the foot, maintain or improve range of motion in the
ankle joint, and improve local blood circulation.
System Components:
• A Functional Stimulation (FS) Cuff (available in regular and small sizes) with a Radio
Frequency (RF) Stim Unit
• An Intelli-Sense Gait Sensor
• A Control Unit
1
System Features:
• The unique ergonomic design of the FS Cuff may allow the FS Cuff to be put on with one
hand, and ensures constant and snug contact between the user’s limb and the FS Cuff’s
integrated electrodes.
• The Intelli-Sense Gait Sensor detects whether the foot is in the air or on the ground.
When the user is walking, the Gait Sensor transmits this information to the rest of the
system, which implements algorithms to synchronize activation of the foot accordingly.
• The wireless Control Unit displays real-time information regarding the system’s status
and manages the system components.
Functional Stimulation Cuff with
Radio Frequency Stim Unit Intelli-Sense
Gait Sensor Control Unit
Regular L300 FS Cuff Small L300 FS Cuff

2Clinician’s Guide
In addition, the NESS L300 features a gait mode for use when walking and a therapeutic
training mode for therapeutic muscle training when not walking.
The NESS L300 Clinician’s Kit contains the components and accessories for fitting and
programming the NESS L300 Foot Drop System. This Clinician’s Guide describes the
Clinician’s Kit contents and instructions for use. A brief description of the NESS L300
system components is provided for reference. Refer to the NESS L300 User’s Guide for
comprehensive information on the NESS L300 System Kit contents and instructions for
use, including set-up, operation, battery charging and replacement, cleaning, component
electronic registration, and troubleshooting.

3
Chapter 2: General Warnings and Precautions
General Warnings and Precautions
Indications for Use
The NESS L300 Foot Drop System is intended to provide ankle dorsiflexion in individuals
(adults and pediatrics) who have foot drop following an upper motor neuron injury or disease.
During the swing phase of gait, the NESS L300 electrically stimulates muscles in the affected
leg to provide dorsiflexion of the foot; thus, it may improve the individual’s gait. The NESS
L300 may also facilitate muscle re-education, prevent or retard disuse atrophy, maintain or
increase joint range of motion, and increase local blood flow.
Contraindications
• Patients with a demand-type cardiac pacemaker, defibrillator, or any electrical or metallic
implant should not use the NESS L300.
• The NESS L300 should not be used where a cancerous lesion is present or suspected.
• The NESS L300 should not be used on a leg where a regional disorder, such as a
fracture or dislocation, would be adversely affected by motion from the stimulation.
• The NESS L300 should not be used on a leg where strength testing or strength training
is planned.
Warnings
• The long-term effects of chronic electrical stimulation are unknown.
• The FS Cuff should not be worn over swollen, infected, or inflamed areas or skin eruptions
such as phlebitis, thrombophlebitis, and varicose veins.
• Simultaneous connection of the NESS L300 to the patient and high-frequency surgical
equipment may result in skin burns where the stimulator electrodes adhere and damage
to the RF Stim Unit.
• Do not use the NESS L300 within three feet of short wave or microwave therapy
equipment. Such equipment may produce instability in the RF Stim Unit output.
• The NESS L300 should only be configured by an authorized clinician.
• 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, thus voiding
the warranty.
2

4Clinician’s Guide
Precautions
• Inflammation in the region of the FS Cuff may be aggravated by motion, muscle activity,
or pressure from the FS Cuff. Advise patients to stop using the NESS L300 until any
inflammation is gone.
• Use caution when treating patients with suspected or diagnosed heart problems.
• Advise patients to use the FS Cuff 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.
• Use caution with patients who have suspected or diagnosed epilepsy.
• Some patients may experience 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 or altering electrode placement.
• Do not use the NESS L300 without electrodes.
• After removing the FS Cuff, it is normal for the areas under the electrodes to be red and
indented. The redness should disappear in approximately one hour. Persistent redness,
lesions, or blisters are signs of irritation. Use of the NESS L300 should be temporarily
halted until any inflammation is resolved completely.
• Advise patients to stop using the NESS L300 and consult their clinician if stimulation
does not start at the correct time during gait.
• Patients should not wear the NESS L300 during x-ray examinations.
• Patients should turn off the NESS L300 when at a refueling place. They should not use
the NESS L300 near flammable fuel, fumes, or chemicals.
• Only the treating clinician should determine electrode placement and stimulation settings.
• Use only NESS L300 electrodes supplied by Bioness Inc.
• Specific physician clearance should be obtained before using the NESS L300 on
patients who have an alteration of normal arterial or venous flow in the region of the FS
Cuff 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 when
patients have a structural deformity in the area to be stimulated.
• The safe use of the NESS L300 during pregnancy has not been established.

5
Chapter 2: General Warnings and Precautions
• Skin problems where the FS Cuff is worn may be aggravated by the NESS L300.
• Turn off the NESS L300 before removing or replacing the electrodes.
• Adult supervision and assistance should be provided for anyone needing help while
using the NESS L300 system.
• Protect all electronic components from contact with water, such as from sinks, bathtubs,
shower stalls, rain, snow, etc.
• Do not leave the NESS L300 stored where temperatures may exceed the recommended
storage temperature range: -20°C to +60°C (-4°F to +140°F). Temperature extremes can
damage the components.
• Should any technical problem occur that is not covered in this guide, contact Bioness Inc.
Do not attempt to repair the NESS L300.
• The FS Cuff is to be worn only on the leg of the patient for whom it is fitted. It should not
be worn by anyone else or on any other part of the body.
• Turn off the NESS L300 before putting on the FS Cuff. Do not turn on the NESS L300
until the FS Cuff is fastened in place.
• Advise patients to turn off the NESS L300 before driving, operating machinery, or
performing any activity in which involuntary muscle contractions may put the patient at
undue risk of injury.
• Avoid the formation of condensation on the NESS L300 electronic components. When
moving the components between hot and cold temperatures, place them in an airtight
plastic bag and let them slowly (for at least two hours) adjust to the temperature change
before use.
• Medical electrical equipment needs special precautions for electromagnetic compatibility.
Adverse Reactions
In the unlikely event that any of the following occurs, advise patients to stop using the NESS
L300 immediately and consult their physician:
• Signs of significant irritation or pressure sores where the FS Cuff contacts the skin.
• A significant increase in muscle spasticity.
• A feeling of heart-related stress during stimulation.
• Swelling of the leg, knee, ankle, or foot.
• Any other unanticipated reaction.
Skin irritations and burns have been reported with the use of powered muscle stimulators.

6Clinician’s Guide
Skin Care Guidelines
In the absence of proper skin care, extended use of electrical stimulation may cause skin
irritation or a skin reaction to the electrodes or the FS Cuff. Skin irritation tends to occur after
approximately three months of use. To ensure healthy skin with long-term use of the NESS
L300, it is important that patients follow a daily skin-care routine.
• Clean the skin where the electrodes adhere with a wet washcloth. If any oils or lotions
are on the skin, then clean with soap and water. Rinse well.
• Always check the skin for redness or a rash when putting on and taking off the FS Cuff.
• Replace the electrodes at least every two weeks, even if they appear to be in good
condition.
• After taking off the FS Cuff, always re-cover hydrogel electrodes with the protective
plastic covers, where applicable.
• Excess body hair where the electrodes adhere may reduce electrode contact with the
skin. If necessary, remove excess body hair with an electric shaver or scissors. Do not
use a razor. A razor can irritate the skin.
• When positioning the FS Cuff, make sure the electrodes uniformly contact the skin.
• Ventilate the skin by removing the FS Cuff for at least 15 minutes every three to four
hours.
If skin irritation or a skin reaction occurs, patients should stop using the NESS L300 immediately
and contact their clinician, dermatologist, or Bioness Clinical Specialist. They should resume
use only when the skin is completely healed, and then follow a skin-conditioning protocol per
the recommendation of a health-care specialist.

7
Chapter 3: Environmental Conditions that Affect Use
3
Environmental Conditions that Affect Use
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 environment. This equipment generates, uses, and can radiate radio frequency
energy and, if not operated 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 environment. If this equipment does cause harmful interference
to radio or television reception, which can be determined by turning the equipment off and
on, the user is encouraged to try to correct the interference by one or more of the following
measures:
• Reorient or relocate the receiving antenna.
• Increase the separation between the equipment and receiver.
Consult the dealer or an experienced radio/TV technician for assistance.
The antenna for each transmitter must not be co-located or operating in conjunction with any
other antenna or transmitter.
Changes or modifications to this equipment not expressly approved by Bioness Inc could
void the user’s authority to operate the equipment.
Portable and mobile RF communications equipment can affect the NESS L300 System.
Conformity Certification
The NESS L300 System complies with Part 15 of the FCC rules. Operation is subject
to the following two conditions:
1. This device may not cause harmful interference, and
2. This device must accept any interference received, including interference that may cause
undesired operation.
Travel
The NESS L300 System charger set with interchangeable blades is compatible with both
European and U.S. voltage: 110/220 V, 50/60 Hz.
Turn off your L300 system before going through airport security. Wear loose clothing so that
you can easily show the security person your NESS L300. The NESS L300 will likely set off

8Clinician’s Guide
the security alarm. Either ask for a “hand scan” or be prepared to remove your NESS L300
so that security can scan it. You may want to carry a copy of your NESS L300 prescription.
A prescription can be useful when passing through customs as well.
To request a copy of your prescription, call Bioness Customer Support: telephone: (800)
211-9136, Option 2; or [phone], Option 2. A Bioness representative can fax or mail
you a copy.
Note: The NESS L300 contains radio transmitters. The Federal Aviation Administration (FAA)
rules require that all radio-transmitting devices be turned off during flight.
Electromagnetic Emissions
The NESS L300 System needs special precautions regarding electromagnetic compatibility
(EMC) and needs to be installed and put into service according to the EMC information
provided in this manual.
The NESS L300 System was tested and certified to use the following:
• DC power supply as provided by Bioness Inc, manufactured by Friwo, Part No.
FW7555M/05.
• “Y” cable (2-way splitter) as provided by Bioness Inc. Manufactured by Tamuz Electronics
Ltd.
Warnings
• The use of accessories, transducers, and cables other than those specified, with the
exception of transducers and cables sold by the manufacturer of the NESS L300 System
as replacement parts for internal components, may result in increased emissions or
decreased immunity of the NESS L300 System.
• The NESS L300 System should not be used adjacent to or stacked with other equipment.
If adjacent or stacked use is necessary, the equipment or system should be observed to
verify normal operation in the configuration in which it will be used.
• The use of the accessory, transducer, or cable with equipment and systems other than
those specified may result in increased emissions or decreased immunity of the NESS
L300 System.
• The NESS L300 System may be interfered with by other equipment, even if that other
equipment complies with CISPR (International Special Committee on Radio Interference,
International Electrotechnical Commission (IEC)) emission requirements.

9
Chapter 4: The NESS L300 Foot Drop System
4
The NESS L300 Foot Drop System
The NESS L300 Foot Drop System consists of an FS Cuff with RF Stim Unit, a Control
Unit, and an Intelli-Sense Gait Sensor. See Figure 4-1. These components communicate
wirelessly to stimulate the common peroneal nerve (normally found posterior and slightly
distal to the head of the fibula) to contract the tibialis anterior and peroneal muscles, thus
causing balanced dorsiflexion (without excessive inversion or eversion).
Stimulation Features:
• The NESS L300 uses electrodes for stimulation of the common peroneal nerve and the
motor point of the tibialis anterior muscle.
• Stimulation is controlled by wireless communication at the appropriate phase of gait.
The effectiveness of eliciting muscle contraction force depends on amplitude, duration,
frequency, and waveform of the electrical stimulation signal. The clinician can impact the
force, efficiency, and timing of the muscle contraction by adjusting stimulation (for example,
amplitude) and gait (for example, ramp) parameters to provide sufficient foot clearance
during walking.
Figure 4-1: NESS L300 system components.
FS Cuff with RF Stim Unit
Control Unit
Intelli-Sense Gait Sensor
Regular L300 FS Cuff Small L300 FS Cuff

10 Clinician’s Guide
Functional Stimulation (FS) Cuff
The L300 FS Cuff is a lightweight, low-profile neuroprosthesis that straps onto the leg directly
under the patella.
The L300 FS Cuff features an ergonomically designed locator for accurate placement, a
cradle for the RF Stim Unit, and an adjustable elastic strap. See Figure 4-2. The Regular
L300 FS Cuff strap is available in three sizes: small (S), medium (M), and large (L). The
Small L300 FS Cuff strap is available in two sizes: extra small (XS) and extra extra small
(XXS). The electrodes and electrode bases attach to the inner liner of the L300 FS Cuff.
The Regular L300 System Kit comes with a medium (M) strap attached to the Regular L300
FS Cuff. The Small L300 System Kit comes with an extra small (XS) strap attached to the
Small L300 FS Cuff. The other available strap sizes are included in the system kits as an
accessory item.
The L300 FS Cuff can easily be worn under most clothing, and is available in right and left
configurations. The Regular L300 FS Cuff is used for leg circumferences ranging from 29 cm
to 51 cm (11 in. to 20 in.). The Small L300 FS Cuff is used for leg circumferences ranging
from 22 cm to 31 cm (8 in. to 12.2 in.).
Figure 4-2: Regular L300 FS Cuff and Small L300 FS Cuff.
Electrode Base
Electrode
Liner
Cradle RF Stim Unit
Strap
Liner
Regular L300 FS Cuff Small L300 FS Cuff
Locator
Locator
Strap
Handle
Strap
Handle
Cradle