L360 Safety Information

Indications for Use

The L360 Thigh System is intended 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 L360 Thigh System electrically stimulates muscles in the affected leg to provide knee flexion or extension; thus, it also may improve the individual’s gait. 

The L360 Thigh System may also:

  • Facilitate muscle re-education
  • Prevent/retard disuse atrophy
  • Maintain or increase joint range of motion
  • Increase local blood flow
  • Provide early post-surgical quadricep and hamstring strengthening
  • Improve post-surgical knee stability secondary to quadricep and hamstring strengthening
  • Relax muscle spasms

Contraindications

  • Patients with a demand-type cardiac pacemaker, defibrillator or any electrical implant should not use the L360 Thigh System.

Warnings

  • The L360 Thigh System should not be used on a leg where a metallic implant is directly underneath the electrodes.
  • The L360 Thigh System should not be applied over, or in proximity to, cancerous lesions.
  • The L360 Thigh 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.
  • The long-term effects of chronic electrical stimulation are unknown.
  • The thigh 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 L360 Thigh System to the patient and high-frequency surgical equipment may result in skin burns where the stimulator electrodes touch and damage to the EPG.
  • Do not use the L360 Thigh System within three feet of short wave or microwave therapy equipment. Such equipment may produce instability in the EPG output.
  • The L360 Thigh System should only be configured by an authorized clinician.
  • In case of any inconvenience, turn off stimulation and remove the thigh cuff. If the stimulation
    cannot be turned off, remove the thigh cuff to stop stimulation.

Precautions

  • Inflammation in the region of the thigh cuff may be aggravated by motion, muscle activity, or pressure from the cuff. Advise patients to stop using the L360 Thigh System until any inflammation is gone.
  • Use caution when treating patients with suspected or diagnosed heart problems.

Advise patients to use the thigh 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.
  • If the patient has suspected or diagnosed epilepsy.

Some patients may experience a skin irritation, an allergic reaction, or hypersensitivity to the
electrical stimulation or the electrical conductive medium. Irritation may be avoided by changing the stimulation parameters or electrode placement.

  • Do not use the L360 Thigh System without electrodes.
  • After removing the thigh 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. Advise patients to stop using their L360 Thigh System until any inflammation is gone and to alert their clinician.
  • Advise patients to stop using their L360 Thigh System and consult their clinician if stimulation does not start at the correct time during gait.
  • Advise patients to turn off the L360 Thigh System when at a refueling place. Do not use the L360 Thigh System near flammable fuel, fumes, or chemicals.
  • Only a treating clinician should determine electrode placement and stimulation settings.
  • The L360 Thigh System should be kept out of the reach of children.
  • Use only the L360 Thigh System electrodes supplied by Bioness.
  • Turn off the L360 Thigh System before removing or replacing the electrodes.
  • Specific physician clearance should be obtained before using the L360 Thigh System on patients who have an alteration of normal arterial or venous flow in the region of the thigh 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 L360 Thigh System when patients have a structural deformity in the area to be stimulated.
  • The safe use of the L360 Thigh System during pregnancy has not been established.
  • Skin problems, on the leg where the thigh cuff is worn, may be aggravated by the L360 Thigh System.
  • Adult supervision and assistance should be provided for anyone needing help while using the L360 Thigh System.
  • The patient is the intended operator of the L360 Thigh 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 L360 Thigh 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 L360 Thigh System. Contact Bioness if you experience a technical problem not covered in this guide.
  • The thigh 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 L360 Thigh System before putting on the thigh cuff. Do not turn on the L360 Thigh System until the thigh cuff is fastened in place.
  • Advise patients to shut off the L360 Thigh System before operating machinery, or performing any activity in which involuntary muscle contractions could cause injury (e.g., driving a car, riding a bicycle, etc.).
  • Protect the L360 Thigh 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.
  • Advise patients to remove the L360 Thigh System before undergoing any diagnostic or therapeutic medical procedure such as X-ray examination, ultrasound, MRI, etc.

Adverse Reactions

In the unlikely event that any of the following occurs, advise patients to stop using their L360 Thigh System immediately and consult their physician:

  • Signs of significant irritation or pressure sores where the thigh 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.

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 thigh cuff. Skin irritation tends to occur after approximately three months of use. To promote healthy skin with long-term use of the L360 Thigh 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 thigh cuff.
  • Replace the electrodes every two weeks or more frequently, even if they appear to be in good condition.
  • Wet cloth based electrodes before use and after 3-4 hours for optimal performance.
  • 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 thigh cuff, make sure the electrodes uniformly contact the skin.
  • Ventilate the skin by removing the thigh cuff for at least 15 minutes every three to four hours.

If skin irritation or a skin reaction occurs,patients should stop using their L360 Thigh System immediately and contact their clinician or dermatologist. They can also contact Bioness Client Support Department at
800-211-9136 (USA and Canada) or your local distributor. Patients should resume use only when the skin is completely healed, and then follow a skin conditioning protocol per the recommendation of their healthcare specialist.

Incident Reporting

Any serious incident that has occurred in relation to the device should be reported to the manufacturer and the competent authority of the member state in which the user and/or patient is established if within the European Union.

Environmental Conditions that Affect Use

Radio Frequency (RF) Communication Information

Several components of the L360 Thigh 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 L360 Thigh System.

Conformity Certification

The L360 Thigh 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.
  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 L360 Thigh System charger with interchangeable blades is compatible with Australian, U.K., European Union, and U.S. voltages: 100-240V, 50/60 Hz.

Advise patients to turn off their L360 Thigh System before going through airport security and to wear loose clothing so they can easily show the security person their L360 Thigh System. The L360 Thigh System will likely set off the security alarm. Patients should be prepared to remove the L360 Thigh System so that security can scan it, or ask for the system to be scanned if they do not want to remove it. It is recommended that patients carry a copy of their L360 Thigh System prescription.

Patients can request a copy of their prescription by contacting Bioness or their physician.

Note: The L360 Thigh 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 L360 Thigh System in flight.

Electromagnetic Emissions

The L360 Thigh 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 15.

The L360 Thigh System was tested and certified to use the following:

  • AC Adapter with interchangeable blades, model number LG4-7200, supplied by Bioness Inc.
  • Magnetic charging cord, model number LG4-7100, supplied by Bioness Inc.

Warnings

  • Do not use the L360 Thigh 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 L360 Thigh System before undergoing any diagnostic or therapeutic medical procedure such as X-ray examination, ultrasound, magnetic resonance imaging (MRI), etc.
  • The L360 Thigh 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 L360 Thigh System as replacement parts for internal components) may result in increased emissions or decreased immunity of the L360 Thigh System.
  • The L360 Thigh 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.