Bioness NESS L300 Plus System User Manual
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Bioness NESS L300 Plus System User Manual

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NESS L300 Plus System
User's Guide
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Duane L Sandoval
March 26, 2025

have older version of L 300+. Can I still use it? haven't used for a while due to other issues. Want to try it and see if can use without any issues in hip area

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Mr. Anderson
March 26, 2025

The provided context does not mention the use of the older version of the Bioness NESS L300 Plus System in the hip area. However, it specifies that the L300 and Thigh FS Cuffs should only be worn on the leg of the patient for whom they were fitted and not on any other part of the body. Therefore, using an older version in the hip area may not be appropriate.

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Summary of Contents for Bioness NESS L300 Plus System

  • Page 1 NESS L300 Plus System User’s Guide Rx Only...
  • Page 2 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.

  • Page 3: Table Of Contents

    Chapter 3: Environmental Conditions that Affect Use ...... 11 Radio Frequency (RF) Communication ............11 Conformity Certification ................12 Travel ........................ 12 Chapter 4: Your NESS L300 Plus System Kit ........13 Contents ......................13 System Components .................. 13 L300 Accessories ..................14 L300 Plus Accessories ................
  • Page 4 NESS L300 Plus Thigh FS Cuff ....................23 Distal and Proximal Panels ................. 24 Elongation Bar .................... 24 Straps ......................24 Surface Electrodes ..................24 Thigh RF Stim Unit ................... 25 Gait Sensor ....................... 27 L300 Plus Control Unit ..................29 Control Unit Operating Buttons ..............
  • Page 5 Preparing the Skin .................... 49 Checking and Wetting the Electrodes .............. 49 Positioning the L300 FS Cuff ................50 Removing the L300 FS Cuff ................54 Positioning the Thigh FS Cuff on the Quadriceps ..........55 Positioning the Thigh FS Cuff on the Hamstrings ..........60 Removing the Thigh FS Cuff ................
  • Page 6 NESS L300 Plus Chapter 9: Component Maintenance and Cleaning ......81 Charging the Batteries ..................81 Replacing the Batteries ..................86 Replacing the RF Stim Unit Batteries ............86 Replacing the Gait Sensor Battery ............. 86 Replacing the L300 Plus Control Unit Battery ..........87 Replacing the L300 Hydrogel Electrodes ............
  • Page 7 List of Symbols Caution 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 Re-Order Number Lot Number...

  • Page 8: Chapter 1: Introduction

    In addition, they may experience difficulty flexing or extending their knee. The NESS L300 Plus System is intended to provide ankle dorsiflexion and knee flexion or extension in people suffering from foot drop and thigh muscle weakness following an upper motor neuron injury or disease.
  • Page 9 The wireless handheld Control Unit monitors system status and manages system performance. This User’s Guide describes the NESS L300 Plus System and how to operate the system to achieve maximum benefits. It also describes important safety information, and maintenance and cleaning instructions.

  • Page 10: Chapter 2: For Your Health And Safety

    For Your Health and Safety Indications for Use The NESS L300 Plus System is intended to provide ankle dorsiflexion and knee flexion or extension in individuals who have foot drop and thigh muscle weakness following an upper motor neuron injury or disease (such as a stroke, traumatic brain injury, multiple sclerosis, cerebral palsy, or incomplete spinal cord injuries).

  • Page 11: Warnings

    NESS L300 Plus • The NESS L300 Plus System should not be used on a leg where a regional disorder, such as a fracture or dislocation, could be adversely affected by motion from the stimulation. Warnings • The long-term effects of chronic electrical stimulation are unknown.
  • Page 12 Only your treating clinician should determine electrode placement and stimulation settings. • Use only NESS L300 Plus electrodes supplied by Bioness Inc. • Obtain physician clearance prior to use if you have an alteration in normal arterial or venous flow in the region of the FS Cuffs because of local insufficiency, occlusion, arteriovenous fistula for hemodialysis, or a primary disorder of the vasculature.
  • Page 13 -20°C to +60°C (-4°F to +140°F). Temperature extremes can damage the components. • Do not attempt to repair your NESS L300 Plus. Contact Bioness if you experience a technical problem not covered in this guide. •...

  • Page 14: Adverse Reactions

    Adverse Reactions In the unlikely event that any of the following occurs, stop using your NESS L300 Plus immediately and consult your physician. • Signs of significant irritation or pressure sores where the FS Cuffs contact the skin. • A significant increase in muscle spasticity. •...

  • Page 15: Skin Care Guidelines

    If skin irritation or a skin reaction occurs, stop using your NESS L300 Plus System immediately. Contact your clinician, dermatologist, or Bioness Clinical Specialist. Resume use only when the skin is completely healed. Then follow a skin conditioning protocol per the recommendation of your health-care specialist.
  • Page 16 Caution: Do not put on or operate the NESS L300 Plus System before being properly fitted and trained by a certified clinician. Caution: The Gait Sensor has not been validated for use by individuals weighing more than 300 pounds (136 kilograms).
  • Page 17 NESS L300 Plus User’s Guide...

  • Page 18: Chapter 3: Environmental Conditions That Affect Use

    Environmental Conditions that Affect Use Radio Frequency (RF) Communication Several components of the NESS L300 Plus 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.

  • Page 19: Conformity Certification

    Wear loose clothing so that you can easily show the security person your NESS L300 Plus. The NESS L300 Plus System will likely set off the security alarm. Either ask for a “hand scan” or be prepared to remove your NESS L300 Plus so that security can scan it.

  • Page 20: Chapter 4: Your Ness L300 Plus System Kit

    Your NESS L300 Plus System Kit Your NESS L300 Plus System includes components and accessories of the NESS L300 Foot Drop System plus a Thigh FS Cuff, Thigh RF Stim Unit, accessories for the Thigh FS Cuff, and a Control Unit. For individuals who already have a NESS L300 Foot Drop System, an L300 Plus System upgrade kit is provided.

  • Page 21: L300 Accessories

    NESS L300 Plus L300 Accessories • L300 Hydrogel Electrodes • L300 Hydrogel Electrode Bases • L300 Cloth Electrodes • L300 Cloth Electrode Bases Hydrogel Electrode • Control Unit Neck Strap • Control Unit Wrist Strap • Control Unit Belt Pouch •...
  • Page 22 Cloth Electrode Cloth Hydrogel Electrode Base Electrode Base Neck Strap Wrist Strap Belt Pouch Gait Sensor Pads Shoe Spacers Phillips Screwdriver Chapter 4 - Your NESS L300 Plus System Kit...

  • Page 23: L300 Plus Accessories

    NESS L300 Plus L300 Plus Accessories • L300 Plus System Charger Set • Thigh FS Cuff Distal Panel Subassembly, Large • Thigh FS Cuff Elongation Bar Lock Set • Thigh FS Cuff Electrode Marking Ring Set System Charger Set • Thigh FS Cuff Cloth Electrodes •...

  • Page 24: L300 Plus Upgrade Kit

    L300 Plus Upgrade Kit For individuals who already have a NESS L300 Foot Drop System, an L300 Plus System upgrade kit is provided. Contents • Thigh FS Cuff with Straps, Right or Left • Thigh RF Stim Unit • L300 Plus Control Unit •...
  • Page 25 NESS L300 Plus User’s Guide...

  • Page 26: Chapter 5: System Components And Accessories

    System Components and Accessories This section describes the components and accessories of the L300 Plus System. L300 Functional Stimulation (FS) Cuff The L300 FS Cuff is an ergonomic orthosis that fits on the leg below the knee. The L300 FS Cuff is designed to facilitate dorsiflexion of the foot. It is lightweight, easy to put on with one hand, and can be worn under loose clothing.

  • Page 27: Locator

    NESS L300 Plus The L300 FS Cuff is available in right and left configurations. It is designed to house an integrated L300 RF Stim Unit and two surface electrodes. The RF Stim Unit produces the stimulation signal. The surface electrodes deliver the stimulation signal from the RF Stim Unit to the leg.

  • Page 28: L300 Rf Stim Unit

    L300 RF Stim Unit The L300 RF Stim Unit generates the electrical stimulation pulses used to dorsiflex the foot. The L300 RF Stim Unit responds to wireless signals from the L300 Plus Control Unit and the Gait Sensor to turn stimulation on/off. Features include a rechargeable battery, a status light, and a stimulation light.
  • Page 29 NESS L300 Plus The L300 RF Stim Unit emits both visual and audio alerts when radio communication fails or the component malfunctions. The L300 RF Stim Unit snaps in and out of the cradle of the L300 FS Cuff. See Figure 2. The L300 RF Stim Unit should only be removed from the cradle for maintenance and when cleaning the L300 FS Cuff.

  • Page 30: Thigh Fs Cuff

    Thigh FS Cuff The Thigh FS Cuff is an ergonomic orthosis that fits over the hamstrings or quadriceps muscles. The Thigh FS Cuff is designed to be used in unison with the L300 FS Cuff, to assist with knee flexion or extension throughout the gait cycle.

  • Page 31: Distal And Proximal Panels

    NESS L300 Plus Distal and Proximal Panels The Thigh FS Cuff features two panels: a distal panel that is positioned closer to the knee and a proximal panel that is positioned farther from the knee. The distal panel features a cradle for the Thigh RF Stim Unit. The L300 Plus System Kit includes a replacement large distal panel that fits a larger leg circumference, if needed.

  • Page 32: Thigh Rf Stim Unit

    Thigh RF Stim Unit The Thigh RF Stim Unit snaps in and out of the cradle of the Thigh FS Cuff. See Figure 4. The Thigh RF Stim Unit generates the electrical stimulation pulses used to extend the quadriceps muscles or flex the hamstrings muscles. The Thigh RF Stim Unit responds to wireless signals from the L300 Plus Control Unit and the Gait Sensor to turn stimulation on/off.
  • Page 33 NESS L300 Plus The Thigh RF Stim Unit emits both visual and audio alerts when radio communication fails or the component malfunctions. The Thigh RF Stim Unit should be removed from the cradle for maintenance and when cleaning the Thigh FS Cuff. Display Description Definition...

  • Page 34: Gait Sensor

    Gait Sensor The Gait Sensor consists of a pressure sensor and a transmitter. See Figure 5. The pressure sensor is used to detect when your foot is in the air and on the ground. The transmitter is used to signal the L300 RF Stim Unit and the Thigh RF Stim Unit to move your foot and knee accordingly.

  • Page 35: Phillips Screwdriver

    NESS L300 Plus The pressure sensor fits under the insole of the shoe of the affected leg, attached to a Gait Sensor pad. See Figure 6. The transmitter is worn clamped to the inner rim of the shoe. Shoe spacers are provided to protect the shoe from damage from the clamp.

  • Page 36: L300 Plus Control Unit

    L300 Plus Control Unit The L300 Plus Control Unit is used to turn on/off the L300 Plus System, select an operating mode (gait, training, standby, or clinician), fine-tune stimulation intensity, mute audio alerts, test stimulation intensity of the individual RF Stim Units, and monitor system performance.

  • Page 37: Control Unit Operating Buttons

    NESS L300 Plus Your L300 Plus System Kit includes a system charger set for charging the Control Unit, the L300 RF Stim Unit, and the Thigh RF Stim Unit. It also includes a belt pouch, wrist strap, and neck strap for carrying the Control Unit.
  • Page 38 Operating Control Unit Description Function Button On/Off Turns On/Off the Control Unit Selects Standby, Gait, Mode Training, or Clinician Mode Intensity Adjusts Stimulation Intensity Adjustment Level (Plus/Minus) "Up" Button Selects the Thigh RF Stim Unit RF Stim Unit Selection "Down" Button Selects the L300 RF Stim Unit Mutes the Audio Indicators;...

  • Page 39: Control Unit Digital Display And Indicator Lights

    NESS L300 Plus muscle re-education, prevent or retard disuse atrophy of the lower leg and thigh muscles, maintain or improve range of motion of the ankle and knee joints, and improve local blood circulation. Control Unit Digital Display and Indicator Lights The Control Unit digital display and indicator lights indicate stimulation intensity level, operating mode, battery charge status, electronic registration status, and error messages.
  • Page 40 Display Description Definition On/Off Button Flashes System is On GREEN Mode Button Flashes System is in Gait/Training/ YELLOW SLOWLY Clinician Mode, Stimulation is Off Mode Button Flashes System is in Gait/Training/ YELLOW RAPIDLY Clinician Mode, Stimulation is On Displays 0–9 Intensity Level Intensity Level and “t”...

  • Page 41: Control Unit Audio Indicators

    NESS L300 Plus Display Description Definition Thigh RF Stim Unit Indicator Faulty Electrode Contact Flashes RED Control Unit and RF Stim Unit Radio Communication Failure Indicators Alternately Flash Between the Control Unit and RF RED and “E” Flashes Stim Unit Gait Sensor and RF Stim Unit Gait Sensor Hibernation or Radio Indicators Alternately Flash...

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