Bioness L300 Go User manual

602-00664-001 Rev. E
12/2018
©2018 Bioness Inc.
Rx Only
Bioness Inc.
25103 Rye Canyon Loop
Valencia, CA 91355 USA
Telephone: [phone] or 661.362.4850
Email: [email protected]
Website: www.bioness.com
Bioness Europe B.V.
Stationsweg 41
3331 LR Zwijndrecht, The Netherlands
Telephone: [phone]
Email: [email protected]
Website: www.bioness.com
MEDICAL - APPLIED CURRENT/ENERGY
EQUIPMENT AS TO ELECTRICAL SHOCK,
FIRE AND MECHANICAL HAZARDS ONLY IN
ACCORDANCE WITH:
ANSI/AAMI ES60601-1 (2005) + AMD 1 (2012)
CAN/CSA-C22.2No. 60601-1 (2014)
E489148

USER’S GUIDE
Functional Electrical Stimulation System

List of Symbols
Caution
Warning
Double Insulated (Equivalent to Class II of IEC 536)
Type BF Applied Part(s)
Non-Ionizing Radiation
Date of Manufacture
Manufacturer
This Product Must Not Be Disposed of with Other Household Waste
Refer to Instruction Manual/Booklet
Re-Order Number
Lot Number
Serial Number
Single Patient Use - To Prevent Cross Contamination
Single Patient Use - To Prevent Cross Contamination
Storage Temperature
Humidity Limitation
Atmospheric Pressure Limitation
Keep Dry
IP22 Degree of Ingress Protection (for Control Unit)
IP42 Degree of Ingress Protection (for EPG)
IP52 Degree of Ingress Protection (for Foot Sensor)
Left
Right
Underwriters Laboratories (UL) is an independent, globally recognized agency that certifies,
validates, tests, inspects and audits corporations and products.
European Authorized Representative

Bioness Europe B.V.
Stationsweg 41
3331 LR Zwijndrecht, The Netherlands
Telephone: [phone]
Email: [email protected]
Website: www.bioness.com
L300 Go User’s Guide Copyright
© 2018, 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
L300 Go®, myBioness™, Bioness and the Bioness Logo®are trademarks of Bioness Inc. | www.bioness.com
Rx Only
Bioness Patents
This product is covered by one or more US and international patents. Additional patents pending. For more
information on patents visit Bioness web site at: http://www.bioness.com/Patents.php
Disclaimer
Bioness Inc. and its affiliates shall not be liable for any injury or damage suffered by any person, either
directly or indirectly, as a result of the unauthorized use or repair of Bioness Inc. products. Bioness Inc.
does not accept any responsibility for any damage caused to its products, either directly or indirectly,
as a result of use and/or repair by unauthorized personnel.
Environmental Policy
Service personnel are advised that when changing any part of the L300 Go System, care should
be taken to dispose of those parts in the correct manner; where applicable, parts should be
recycled. For more detailed information regarding these recommended procedures, please
contact Bioness Inc. Bioness Inc. is committed to continuously seeking and implementing
the best possible manufacturing procedures and servicing routines.
Bioness Inc
25103 Rye Canyon Loop
Valencia, CA 91355 USA
Telephone: [phone]
Email: [email protected]
Website: www.bioness.com

iv
Table of Contents
Chapter 1: Introduction................................................................................... 1
Chapter 2: Safety Information ........................................................................ 3
Indications for Use.......................................................................................................... 3
Contraindications............................................................................................................ 3
Warnings ........................................................................................................................ 4
Precautions..................................................................................................................... 4
Adverse Reactions ......................................................................................................... 7
Skin Care Guidelines...................................................................................................... 7
Chapter 3: Environmental Conditions that Affect Use................................. 9
Radio Frequency (RF) Communication Information ....................................................... 9
Conformity Certification .................................................................................................. 9
Travel and Airport Security ............................................................................................. 10
Electromagnetic Emissions ............................................................................................ 10
Warnings ........................................................................................................................ 11
Chapter 4: L300 Go System Kits .................................................................... 13
Contents ......................................................................................................................... 13
Chapter 5: Device Description ....................................................................... 19
Lower Leg FS Cuff ......................................................................................................... 19
Thigh FS Cuff ................................................................................................................ 19
Lower Leg EPG and Thigh EPG..................................................................................... 20
Control Unit..................................................................................................................... 23
Foot Sensor.................................................................................................................... 26
Lower Leg FS Cuff Electrodes and Electrode Bases ..................................................... 28
Thigh FS Cuff Electrodes ............................................................................................... 30
Home Use Cuff Cover .................................................................................................... 31
Home Use Strap Holder ................................................................................................. 32
Chapter 6: Setup Instructions ........................................................................ 35

vUser's Guide
Charging the L300 Go System ...................................................................................... 35
Preparing the Skin.......................................................................................................... 37
Attaching the Electrodes................................................................................................. 37
Positioning the Lower Leg FS Cuff................................................................................. 43
Testing the Position of the Lower Leg FS Cuff ............................................................... 45
Removing the Lower Leg FS Cuff .................................................................................. 45
Positioning the Thigh FS Cuff ........................................................................................ 45
Testing the Position of the Thigh FS Cuff ....................................................................... 47
Removing the Thigh FS Cuff .......................................................................................... 47
Positioning the Foot Sensor ........................................................................................... 47
Chapter 7: Operating the L300 Go System ................................................... 51
Turning the L300 Go System On/Off .............................................................................. 51
Selecting an Operating Mode Using the Control Unit..................................................... 51
Adjusting Stimulation Intensity........................................................................................ 53
Changing Audio and Vibration Feedback Using the Control Unit ................................... 54
Turning Stimulation Off Using the Control Unit and EPG ............................................... 55
Chapter 8: Maintenance and Cleaning .......................................................... 57
Daily Maintenance and Storage ..................................................................................... 57
Charging......................................................................................................................... 57
Replacing the EPG Battery............................................................................................. 58
Replacing the Foot Sensor Battery................................................................................. 58
Replacing the Control Unit Battery ................................................................................. 59
Replacing the Quick Fit Electrodes ................................................................................ 60
Replacing the Hydrogel Electrodes ................................................................................ 63
Replacing the Electrode Bases ...................................................................................... 65
Replacing the Steering Electrodes ................................................................................. 66
Replacing the Thigh Cloth Electrodes ............................................................................ 68
Removing the EPG......................................................................................................... 69

vi
Removing the Thigh FS Cuff Straps............................................................................... 70
Removing the Home Use Thigh Cuff Cover ................................................................... 71
Cleaning Your L300 Go System Components ................................................................ 72
Disinfecting Your L300 Go System Components............................................................ 74
Disinfecting the Control Unit and EPG ........................................................................... 75
Chapter 9: Pairing Replacement Part Components ..................................... 77
Pairing Setup.................................................................................................................. 77
Pairing a Lower Leg EPG to a Thigh EPG ..................................................................... 77
Pairing a New Control Unit to the EPG........................................................................... 78
Pairing a New Foot Sensor to the EPG.......................................................................... 78
Chapter 10: Troubleshooting.......................................................................... 81
Error Code Descriptions ................................................................................................. 81
Testing the Functionality of the Alert Indicator................................................................ 83
Frequently Asked Questions........................................................................................... 83
Chapter 11: Technical Specifications ............................................................ 87
Chapter 12: Wireless Information .................................................................. 97
System Characteristics .................................................................................................. 97
Electromagnetic compatibility (EMC) Information........................................................... 98

vii User's Guide

1
Chapter 1 - Introduction
Chapter 1
Introduction
Central nervous system (CNS) injuries 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 and other disabilities also suffer from thigh muscle weakness
that is concurrent with or independent of foot drop. Weak thigh muscles can cause
considerable difficulties with flexing or extending the knee during ambulation.
The L300 Go System is designed to improve gait in people suffering from foot
drop and/or with thigh muscle weakness. The L300 Go System also can deliver
stimulation to either or both the muscles in the upper and lower leg to facilitate
muscle re-education, prevent/retard disuse atrophy, maintain or increase joint range
of motion, and/or increase local blood flow. The L300 Go System consists of a lower
leg Functional Stimulation (FS) Cuff (available in regular and small sizes) with an
External Pulse Generator (EPG), a thigh Functional Stimulation (FS) Cuff with an
EPG, an optional Control Unit, and an optional Foot Sensor. These components
communicate wirelessly to electrically stimulate muscles in the affected leg to raise
the foot and/or to provide knee flexion or extension. The lower leg FS Cuff and thigh
FS Cuff can be used either independently or together.
The L300 Go System is designed to be used in a Hospital/Professional Healthcare
Facility or Residential/Home Healthcare environment.

2User's Guide
Figure 1-1: L300 Go System
This L300 Go User's Guide describes:
• Important safety information about the L300 Go System.
• The components of the L300 Go System.
• How to set up, operate, and maintain your L300 Go System.
• Troubleshooting information.
Be sure to review this guide with your clinician before using your L300 Go System. If
you have any questions contact Bioness Technical Support at 800.211.9136, Option
3. You can also visit the Bioness website at: www.bioness.com.
Caution: Do not put on or operate the L300 Go System before being properly fitted
and trained by a certified clinician.
Lower Leg FS Cuff
with EPG
Control Unit
(optional)
Foot Sensor
(optional)
Thigh FS Cuff
with EPG

3
Chapter 2 - Safety Information
Chapter 2
Safety Information
Indications for Use
The L300 Go System is intended to provide ankle dorsiflexion in adult and pediatric
individuals with foot drop and/or to assist knee flexion or extension in adult individuals
with muscle weakness related to upper motor neuron disease/injury (e.g., stroke,
damage to pathways to the spinal cord). The L300 Go System electrically stimulates
muscles in the affected leg to provide ankle dorsiflexion of the foot and/or knee
flexion or extension; thus, it also may improve the individual’s gait.
The L300 Go System may also:
• Facilitate muscle re-education
• Prevent/retard disuse atrophy
• Maintain or increase joint range of motion
• Increase local blood flow
Contraindications
• Users with a demand-type cardiac pacemaker, defibrillator or any electrical
implant should not use the L300 Go System.
• The L300 Go System should not be used on a leg where a metallic implant is
directly underneath the electrodes.
• The L300 Go System should not be used on a leg where a cancerous lesion
is present or suspected.
• The L300 Go 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.

4User's Guide
Warnings
• The long-term effects of chronic electrical stimulation are unknown.
• The lower leg FS Cuff and thigh 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 L300 Go System to the user and high-
frequency surgical equipment may result in skin burns where the stimulator
electrodes touch and damage to the EPG.
• Do not use the L300 Go System within three feet of short wave or microwave
therapy equipment. Such equipment may produce instability in the EPG
output.
• The L300 Go System should only be configured by an authorized clinician.
• In case of any inconvenience, turn off stimulation and remove the lower leg
FS Cuff and/or thigh FS Cuff. If the stimulation cannot be turned off, remove
the FSC to stop stimulation.
Precautions
• Inflammation in the region of the lower leg FS Cuff and thigh FS Cuff may be
aggravated by motion, muscle activity, or pressure from the cuff. Stop using
the L300 Go System until any inflammation is gone.
• Use caution if you have a suspected or diagnosed heart problem.
• Use caution if you have suspected or diagnosed epilepsy.
• Use the lower leg FS Cuff and thigh FS Cuff with caution:
• If you have a tendency to bleed heavily following acute trauma or fracture.
• Following recent surgical procedures when muscle contraction may
disrupt the healing process.
• Over areas of the skin that lack normal sensation.
• If you have suspected or diagnosed epilepsy.

5
Chapter 2 - Safety Information
• Some users may experience a skin irritation, an allergic reaction, or
hypersensitivity to the electrical stimulation or the electrical conductive
medium. Irritation may be avoided by having your clinician change the
stimulation parameters, type of electrodes, or electrode placement.
• Do not use the L300 Go System without electrodes.
• After removing the lower leg FS Cuff and/or thigh 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. Alert your clinician and stop using the L300 Go System
until any inflammation is gone.
• Stop using the L300 Go System and consult your clinician if stimulation does
not start at the correct time during gait.
• Turn off the L300 Go System when at a refueling place. Do not use the L300
Go System near flammable fuel, fumes, or chemicals.
• Only your treating clinician should determine electrode placement and
stimulation settings.
• Use only the L300 Go System electrodes supplied by Bioness Inc.
• Turn off the L300 Go System before removing or replacing the electrodes.
• Obtain physician clearance prior to use if you have an alteration in normal
arterial or venous flow in the region of the FSC because of local insufficiency,
occlusion, arteriovenous fistula for hemodialysis, or a primary disorder of the
vasculature.
• Obtain physician clearance before stimulating an area with a structural
deformity.
• The safe use of the L300 Go System during pregnancy has not been
established.
• Skin problems, on the leg where the lower leg FS Cuff and/or thigh FS Cuff is
worn, may be aggravated by the L300 Go System.
• Adult supervision and assistance should be provided for anyone needing help
while using the L300 Go System.

6User's Guide
• The patient/user is the intended operator of the L300 Go System.
• The Control Unit neck strap is meant to be worn around the neck and if not
used properly could cause bodily harm.
• Protect all electronic components from contact with water, such as from sinks,
bathtubs, shower stalls, rain, snow, etc.
• Do not leave the L300 Go 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.
• Do not attempt to repair your L300 Go System. Contact Bioness if you
experience a technical problem not covered in this guide.
• The lower leg FS Cuff and thigh FS Cuff is to be worn only on the leg of the
user for whom it is fitted. It should not be worn by anyone else or on any other
part of the body.
• Turn off the L300 Go System before putting on the lower leg FS Cuff and/or
thigh FS Cuff. Do not turn on the L300 Go System until the lower leg FS Cuff
and/or thigh FS Cuff is fastened in place.
• Shut off the L300 Go System before operating machinery or performing any
activity in which involuntary muscle contractions could injure you (e.g. driving
a car, riding a bicycle, etc.).
• Protect the L300 Go System electronic components from condensation. 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.
• Remove the L300 Go System before undergoing any diagnostic or therapeutic
medical procedure such as Xray examination, ultrasound, MRI, etc.
• Keep away from pets and pests. While not in use, keep away from children.
For pediatric use and indications consult the user manual. Care should be
taken when removing small parts from the system, which may be accidentally
swallowed. If swallowed, consult a doctor immediately.

7
Chapter 2 - Safety Information
• Do not modify or alter the system in any way and only use Bioness supplied
or approved components and parts.
• While the L300 Go (small lower cuff) is designed to fit and be worn by both
pediatric users and small individuals, the system is intended to be managed
and maintained only by adult users, adult caregivers and/or healthcare
professionals.
Adverse Reactions
In the unlikely event that any of the following occurs, stop using your L300 Go System
immediately and consult your 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 beneath the electrodes have been reported with the use
of powered muscle stimulators.
Skin Care Guidelines
In the absence of proper skin care, extended use of electrical stimulation may cause
skin irritation or a skin reaction to the electrodes or the lower leg FS Cuff and thigh
FS Cuff. To promote healthy skin with long-term use of the L300 Go System, it is
important to 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 lower leg FS Cuff and/or thigh FS Cuff.

8User's Guide
• Replace the electrodes at least every two weeks, even if they appear to be in
good condition.
• If using cloth based electrodes before use and after every 3-4 hours wet for
optimal performance.
• After taking off the lower leg FS Cuff and/or thigh 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 lower leg FS Cuff and/or thigh FS Cuff, make sure the
electrodes uniformly contact the skin.
• Ventilate the skin by removing the lower leg FS Cuff and thigh FS Cuff for at
least 15 minutes every three to four hours.
If skin irritation or a skin reaction occurs, stop using your L300 Go System immediately
and contact your clinician or dermatologist. You can also contact Bioness Technical
Support at 800.211.9136, Option 3. Resume use only when the skin is completely
healed, and then follow a skin conditioning protocol per the recommendation of your
health-care specialist.

9
Chapter 3 - Environmental Conditions that Affect Use
Chapter 3
Environmental Conditions that Affect Use
Radio Frequency (RF) Communication Information
Several components of the L300 Go System communicate via radio communication
and have been tested and found to comply with the limits for a Class B digital
device, pursuant to Part 15 (RF Devices) of the FCC (Federal Communications
Commission) Rules. These limits are designed to provide reasonable protection
against harmful interference in a residential installation. This equipment generates,
uses, and can radiate RF energy and, if not installed and used in accordance with
the instructions, may cause harmful interference to radio communications. However,
there is no guarantee that interference will not occur in a particular installation. If this
equipment does cause harmful interference to radio or television reception, which
can be determined by turning the equipment off and on, the user is encouraged to
try to correct the interference by one or more of the following measures:
• 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 may affect the L300 Go System
Conformity Certification
The L300 Go 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.

10 User's Guide
2. This device must accept any interference received, including interference that
may cause undesired operation.
This equipment complies with FCC RF radiation exposure limits set forth for an
uncontrolled environment.
Travel and Airport Security
The L300 Go System charger with interchangeable charging adapters is compatible
with Australian, U.K., European Union, and U.S. voltages: 100-240V, 50/60 Hz.
Turn off your L300 Go System before going through airport security. Wear loose
clothing so that you can easily show the security person your L300 Go System. The
L300 Go System will likely set off the security alarm. Be prepared to remove the
L300 Go System so that security can scan it, or ask for the system to be scanned if
you do not want to remove it. It is recommended that you carry a copy of your L300
Go System prescription.
To request a copy of your prescription, contact Bioness or your physician.
Note: The L300 Go System contains radio transmitters. The Federal Aviation
Administration rules require that all radio-transmitting devices be turned off during
flight. Consult with your airline about use of Bluetooth Low Energy before turning on
your L300 Go system in flight.
Electromagnetic Emissions
The L300 Go System needs special precautions regarding electromagnetic compatibility
(EMC). The system needs to be installed and put into service according to the EMC
information provided in this manual. See Chapter 12.
The L300 Go System was tested and certified to use the following:
• AC Adapter with interchangeable blades, model number LG4-7200, supplied
by Bioness Inc.

11
Chapter 3 - Environmental Conditions that Affect Use
• Magnetic Charging Cord, model number LG4-7100, supplied by Bioness Inc.
Warnings
• Do not use the L300 Go System within three feet (1 meter) of shortwave or
microwave therapy equipment. Such equipment may produce instability in the
output of the EPG.
• Remove the L300 Go System before undergoing any diagnostic or
therapeutic medical procedure such as Xray examination, ultrasound,
Magnetic Resonance Imaging (MRI), etc.
• The L300 Go 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 accessories, transducers, and cables other than those specified
(with the exception of transducers and cables sold by the manufacturer of the
L300 Go System as replacement parts for internal components) may result in
increased emissions or decreased immunity of the L300 Go System.
• The L300 Go System may be interfered with by other equipment, even if
that other equipment complies with CISPR (International Special Committee
on Radio Interference, International Electrotechnical Commission) emission
requirements.
• If the audio alert volume level is lower than the ambient levels, the ambient
levels can impede user recognition of the alert conditions.