Transcription

Bioness Inc.25103 Rye Canyon LoopValencia, CA 91355 USATelephone: 800.211.9136 or 661.362.4850Email: [email protected]: www.bioness.comBioness Europe B.V.Stationsweg 413331 LR Zwijndrecht, The NetherlandsTelephone: 31.78.625.6088Email: [email protected]: www.bioness.comRx Only 2019 Bioness Inc.602-00664-001 Rev. F05/20192797MEDICAL - APPLIED CURRENT/ENERGYEQUIPMENT AS TO ELECTRICAL SHOCK,FIRE AND MECHANICAL HAZARDS ONLY INACCORDANCE WITH:ANSI/AAMI ES60601-1 (2005) AMD 1 (2012)CAN/CSA-C22.2No. 60601-1 (2014)E489148

Functional Electrical Stimulation SystemUSER’S GUIDE

List of SymbolsCautionWarningDouble Insulated (Equivalent to Class II of IEC 536)Type BF Applied Part(s)Non-Ionizing RadiationDate of ManufactureManufacturerThis Product Must Not Be Disposed of with Other Household WasteRefer to Instruction Manual/BookletRe-Order NumberLot NumberSerial NumberSingle Patient Use - To Prevent Cross ContaminationSingle Patient Use - To Prevent Cross ContaminationMDMedical DeviceStorage TemperatureHumidity LimitationAtmospheric Pressure LimitationKeep DryIP22Degree of Ingress Protection (for Control Unit)IP42Degree of Ingress Protection (for EPG)IP52Degree of Ingress Protection (for Foot Sensor)LeftRightUnderwriters Laboratories (UL) is an independent, globally recognized agency that certifies,validates, tests, inspects and audits corporations and products.European Authorized Representative

L300 Go User’s Guide Copyright 2019, Bioness Inc.All Rights ReservedNo part of this publication may be reproduced, transmitted, transcribed, stored in a retrieval system, ortranslated into any language or any computer language, in any form or by any third party, without the priorwritten permission of Bioness Inc.TrademarksL300 Go , myBioness , Bioness and the Bioness Logo are trademarks of Bioness Inc. www.bioness.comRx OnlyBioness PatentsThis product is covered by one or more US and international patents. Additional patents pending. For moreinformation on patents visit Bioness web site at: s Inc. and its affiliates shall not be liable for any injury or damage suffered by any person, eitherdirectly 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 PolicyService personnel are advised that when changing any part of the L300 Go System, care shouldbe taken to dispose of those parts in the correct manner; where applicable, parts should berecycled. For more detailed information regarding these recommended procedures, pleasecontact Bioness Inc. Bioness Inc. is committed to continuously seeking and implementingthe best possible manufacturing procedures and servicing routines.Bioness Inc25103 Rye Canyon LoopValencia, CA 91355 USATelephone: 800.211.9136Email: [email protected]: www.bioness.comBioness Europe B.V.Stationsweg 413331 LR Zwijndrecht, The NetherlandsTelephone: 31.78.625.6088Email: [email protected]: www.bioness.com2797

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

Charging the L300 Go System . 35Preparing the Skin. 37Attaching the Electrodes. 37Positioning the Lower Leg FS Cuff. 43Testing the Position of the Lower Leg FS Cuff. 45Removing the Lower Leg FS Cuff. 45Positioning the Thigh FS Cuff . 45Testing the Position of the Thigh FS Cuff. 47Removing the Thigh FS Cuff. 47Positioning the Foot Sensor. 47Chapter 7: Operating the L300 Go System. 51Turning the L300 Go System On/Off. 51Selecting an Operating Mode Using the Control Unit. 51Adjusting Stimulation Intensity. 53Changing Audio and Vibration Feedback Using the Control Unit. 54Turning Stimulation Off Using the Control Unit and EPG. 55Chapter 8: Maintenance and Cleaning. 57Daily Maintenance and Storage. 57Charging. 57Replacing the Foot Sensor Battery. 58Replacing the Control Unit Battery. 59Replacing the Quick Fit Electrodes. 60Replacing the Hydrogel Electrodes. 64Replacing the Electrode Bases. 66Replacing the Steering Electrodes. 67Replacing the Thigh Cloth Electrodes. 69Removing the EPG. 70Removing the Thigh FS Cuff Straps. 71vUser's Guide

Removing the Home Use Thigh Cuff Cover. 72Cleaning Your L300 Go System Components. 73Disinfecting Your L300 Go System Components. 75Disinfecting the Control Unit and EPG. 76Chapter 9: Pairing Replacement Part Components. 77Pairing Setup. 77Pairing a Lower Leg EPG to a Thigh EPG. 77Pairing a New Control Unit to the EPG. 78Pairing a New Foot Sensor to the EPG. 78Chapter 10: Troubleshooting. 81Error Code Descriptions. 81Testing the Functionality of the Alert Indicator. 83Frequently Asked Questions. 84Chapter 11: Technical Specifications. 87Chapter 12: Wireless Information. 97System Characteristics . 97Electromagnetic compatibility (EMC) Information. 98vi

viiUser's Guide

Chapter1IntroductionCentral 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 oftendrag their foot, resulting in instability and increased effort during gait. Many people withCNS injuries/diseases and other disabilities also suffer from thigh muscle weaknessthat is concurrent with or independent of foot drop. Weak thigh muscles can causeconsiderable difficulties with flexing or extending the knee during ambulation.The L300 Go System is designed to improve gait in people suffering from footdrop and/or with thigh muscle weakness. The L300 Go System also can deliverstimulation to either or both the muscles in the upper and lower leg to facilitatemuscle re-education, prevent/retard disuse atrophy, maintain or increase joint rangeof motion, and/or increase local blood flow. The L300 Go System consists of a lowerleg Functional Stimulation (FS) Cuff (available in regular and small sizes) with anExternal Pulse Generator (EPG), a thigh Functional Stimulation (FS) Cuff with anEPG, an optional Control Unit, and an optional Foot Sensor. These componentscommunicate wirelessly to electrically stimulate muscles in the affected leg to raisethe foot and/or to provide knee flexion or extension. The lower leg FS Cuff and thighFS Cuff can be used either independently or together.The L300 Go System is designed to be used in a Hospital/Professional HealthcareFacility or Residential/Home Healthcare environment.Chapter 1 - Introduction1

Foot Sensor(optional)Control Unit(optional)Thigh FS Cuffwith EPGLower Leg FS Cuffwith EPGFigure 1-1: L300 Go SystemThis 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. Ifyou have any questions contact Bioness Client Support Department at 800.211.9136,Option 3 (USA & Canada) or your local distributor. You can also visit the Bionesswebsite at: www.bioness.com.Caution: Do not put on or operate the L300 Go System before being properly fittedand trained by a certified clinician.2User's Guide

Chapter2Safety InformationIndications for UseThe L300 Go System is intended to provide ankle dorsiflexion in adult and pediatricindividuals with foot drop and/or to assist knee flexion or extension in adult individualswith muscle weakness related to upper motor neuron disease/injury (e.g., stroke,damage to pathways to the spinal cord). The L300 Go System electrically stimulatesmuscles in the affected leg to provide ankle dorsiflexion of the foot and/or kneeflexion 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 flowContraindications Users with a demand-type cardiac pacemaker, defibrillator or any electricalimplant should not use the L300 Go System. The L300 Go System should not be used on a leg where a metallic implant isdirectly underneath the electrodes. The L300 Go System should not be used on a leg where a cancerous lesionis 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 motionfrom the stimulation.Chapter 2 - Safety Information3

Warnings The long-term effects of chronic electrical stimulation are unknown. The lower leg FS Cuff and thigh FS Cuff should not be worn overswollen, 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 highfrequency surgical equipment may result in skin burns where the stimulatorelectrodes touch and damage to the EPG. Do not use the L300 Go System within three feet of short wave or microwavetherapy equipment. Such equipment may produce instability in the EPGoutput. The L300 Go System should only be configured by an authorized clinician. In case of any inconvenience, turn off stimulation and remove the lower legFS Cuff and/or thigh FS Cuff. If the stimulation cannot be turned off, removethe FSC to stop stimulation.Precautions Inflammation in the region of the lower leg FS Cuff and thigh FS Cuff may beaggravated by motion, muscle activity, or pressure from the cuff. Stop usingthe 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 maydisrupt the healing process. Over areas of the skin that lack normal sensation. If you have suspected or diagnosed epilepsy.4User's Guide

Some users may experience a skin irritation, an allergic reaction, orhypersensitivity to the electrical stimulation or the electrical conductivemedium. Irritation may be avoided by having your clinician change thestimulation 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 forthe areas under the electrodes to be red and indented. The redness shoulddisappear in approximately one hour. Persistent redness, lesions, or blistersare signs of irritation. Alert your clinician and stop using the L300 Go Systemuntil any inflammation is gone. Stop using the L300 Go System and consult your clinician if stimulation doesnot start at the correct time during gait. Turn off the L300 Go System when at a refueling place. Do not use the L300Go System near flammable fuel, fumes, or chemicals. Only your treating clinician should determine electrode placement andstimulation 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 normalarterial or venous flow in the region of the FSC because of local insufficiency,occlusion, arteriovenous fistula for hemodialysis, or a primary disorder of thevasculature. Obtain physician clearance before stimulating an area with a structuraldeformity. The safe use of the L300 Go System during pregnancy has not beenestablished. Skin problems, on the leg where the lower leg FS Cuff and/or thigh FS Cuff isworn, may be aggravated by the L300 Go System. Adult supervision and assistance should be provided for anyone needing helpwhile using the L300 Go System.Chapter 2 - Safety Information5

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 notused 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 exceedthe 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 youexperience 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 theuser for whom it is fitted. It should not be worn by anyone else or on any otherpart of the body. Turn off the L300 Go System before putting on the lower leg FS Cuff and/orthigh FS Cuff. Do not turn on the L300 Go System until the lower leg FS Cuffand/or thigh FS Cuff is fastened in place. Shut off the L300 Go System before operating machinery or performing anyactivity in which involuntary muscle contractions could injure you (e.g. drivinga car, riding a bicycle, etc.). Protect the L300 Go System electronic components from condensation. Whenmoving the components between hot and cold temperatures, place them inan airtight plastic bag, and let them slowly (for at least two hours) adjust to thetemperature change before use. Medical electrical equipment needs special precautions for electromagneticcompatibility. Remove the L300 Go System before undergoing any diagnostic or therapeuticmedical 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 betaken when removing small parts from the system, which may be accidentallyswallowed. If swallowed, consult a doctor immediately.6User's Guide

Do not modify or alter the system in any way and only use Bioness suppliedor approved components and parts. While the L300 Go (small lower cuff) is designed to fit and be worn by bothpediatric users and small individuals, the system is intended to be managedand maintained only by adult users, adult caregivers and/or healthcareprofessionals.Adverse ReactionsIn the unlikely event that any of the following occurs, stop using your L300 Go Systemimmediately and consult your physician: Signs of significant irritation or pressure sores where the FS Cuff contacts theskin. 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 useof powered muscle stimulators.Skin Care GuidelinesIn the absence of proper skin care, extended use of electrical stimulation may causeskin irritation or a skin reaction to the electrodes or the lower leg FS Cuff and thighFS Cuff. To promote healthy skin with long-term use of the L300 Go System, it isimportant to follow a daily skin-care routine. Clean the skin where the electrodes adhere with a wet washcloth. If any oilsor 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 offthe lower leg FS Cuff and/or thigh FS Cuff.Chapter 2 - Safety Information7

Replace the electrodes at least every two weeks, even if they appear to be ingood condition. If using cloth based electrodes before use and after every 3-4 hours wet foroptimal performance. After taking off the lower leg FS Cuff and/or thigh FS Cuff, always re-coverhydrogel electrodes with the protective plastic covers, where applicable. Excess body hair where the electrodes adhere may reduce electrode contactwith the skin. If necessary, remove excess body hair with an electric shaver orscissors. 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 theelectrodes uniformly contact the skin. Ventilate the skin by removing the lower leg FS Cuff and thigh FS Cuff for atleast 15 minutes every three to four hours.If skin irritation or a skin reaction occurs, stop using your L300 Go System immediatelyand contact your clinician or dermatologist. You can also contact Bioness ClientSupport Department at 800.211.9136, Option 3 (USA & Canada) or your localdistributor. Resume use only when the skin is completely healed, and then followa skin conditioning protocol per the recommendation of your health-care specialist.Incident ReportingAny serious incident that has occurred in relation to the device should be reportedto the manufacturer and the competent authority of the Member State in which theuser and/or patient is established if within the European Union.8User's Guide

Chapter3Environmental Conditions that Affect UseRadio Frequency (RF) Communication InformationSeveral components of the L300 Go System communicate via radio communicationand have been tested and found to comply with the limits for a Class B digitaldevice, pursuant to Part 15 (RF Devices) of the FCC (Federal CommunicationsCommission) Rules. These limits are designed to provide reasonable protectionagainst harmful interference in a residential installation. This equipment generates,uses, and can radiate RF energy and, if not installed and used in accordance withthe instructions, may cause harmful interference to radio communications. However,there is no guarantee that interference will not occur in a particular installation. If thisequipment does cause harmful interference to radio or television reception, whichcan be determined by turning the equipment off and on, the user is encouraged totry 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 assistanceThe antenna for each transmitter must not be co-located or operating in conjunctionwith any other antenna or transmitterPortable and mobile RF communications equipment may affect the L300 Go SystemConformity CertificationThe L300 Go System complies with Part 15 of the FCC rules. Operation is subjectto the following two conditions:1. This device may not cause harmful interference.Chapter 3 - Environmental Conditions that Affect Use9

2. This device must accept any interference received, including interference thatmay cause undesired operation.This equipment complies with FCC RF radiation exposure limits set forth for anuncontrolled environment.Travel and Airport SecurityThe L300 Go System charger with interchangeable charging adapters is compatiblewith 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 looseclothing so that you can easily show the security person your L300 Go System. TheL300 Go System will likely set off the security alarm. Be prepared to remove theL300 Go System so that security can scan it, or ask for the system to be scanned ifyou do not want to remove it. It is recommended that you carry a copy of your L300Go System prescription.To request a copy of your prescription, contact Bioness or your physician.Note: The L300 Go System contains radio transmitters. The Federal AviationAdministration rules require that all radio-transmitting devices be turned off duringflight. Consult with your airline about use of Bluetooth Low Energy before turning onyour L300 Go system in flight.Electromagnetic EmissionsThe L300 Go System needs special precautions regarding electromagnetic compatibility(EMC). The system needs to be installed and put into service according to the EMCinformation 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, suppliedby Bioness Inc.10User's Guide

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 ormicrowave therapy equipment. Such equipment may produce instability in theoutput of the EPG. Remove the L300 Go System before undergoing any diagnostic ortherapeutic 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 otherequipment. If adjacent or stacked use is necessary, the equipment or systemshould be observed to verify normal operation in the configuration in which itwill 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 theL300 Go System as replacement parts for internal components) may result inincreased emissions or decreased immunity of the L300 Go System. The L300 Go System may be interfered with by other equipment, even ifthat other equipment complies with CISPR (International Special Committeeon Radio Interference, International Electrotechnical Commission) emissionrequirements. If the audio alert volume level is lower than the ambient levels, the ambientlevels can impede user recognition of the alert conditions.Chapter 3 - Environmental Conditions that Affect Use11

12User's Guide

Chapter4L300 Go System KitsContentsL300 Go System, Small Lower Leg Box Container Small lower leg Functional Stimulation (FS) Cuff, Right or Left,with (XS) Strap Central External Pulse Generator (EPG) System Charger (with charging adapters) Magnetic Charging Cord Small lower leg FS Cuff Strap (XXS) L300 Go User’s Guide L300 Go User's Reference CardL300 Go System, Lower Leg Box Container Regular lower leg Functional Stimulation (FS) Cuff, Right or Left,with (Medium) Strap Central External Pulse Generator (EPG) System Charger (with charging adapters) Magnetic Charging Cable Cuff Snap Covers (attached to the lower leg FS Cuff) L300 Go User’s Guide L300 Go User's Reference CardChapter 4 - L300 Go System Kits13

L300 Go System, Thigh Plus (Used with the Lower Leg System Kit) Box Container Thigh Functional Stimulation (FS) Cuff, Right or Left Peripheral External Pulse Generator (EPG) Magnetic Charging Cable Thigh Cuff Strap Set with Buckles (Small) Thigh Cuff Strap Set with Buckles (Medium) Thigh Cuff Strap Set with Buckles (Large) Thigh Electrode Set Home Use Cover Home Use Strap Holder L300 Go User’s Guide L300 Go User's Reference Card14User's Guide

L300 Go System, Thigh Stand-Alone Box Container Thigh Functional Stimulation (FS) Cuff, Right or Left Central External Pulse Generator (EPG) Foot Sensor (optional, not included) Foot Sensor Battery (optional, not included) System Charger (with charging adapters) Magnetic Charging Cable Thigh Cuff Strap Set with Buckles (Small) Thigh Cuff Strap Set with Buckles (Medium) Thigh Cuff Strap Set with Buckles (Large) Thigh Electrode Set Home Use Cover Home Use Strap Holder Foot Sensor Pads (optional, not included) Replacement Battery L300 Go User’s Guide L300 Go User's Reference CardChapter 4 - L300 Go System Kits15

Small Lower Leg FSCuff with EPGFoot SensorSystem Charger withMagnetic Charging Cord16User's GuideRegular Lower Leg FSCuff with EPGControl UnitLower Leg FS

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,