L100 Go Safety Information
Indications for Use
The L100 Go System is intended to provide ankle dorsiflexion in adults with foot drop or muscle weakness related to upper motor neuron disease/injury (e.g., stroke, damage to pathways to the spinal cord). The L100 Go System electrically stimulates muscles in the affected leg to provide ankle dorsiflexion of the foot; thus, it also may improve the adult’s gait.
The L100 Go System may also:
- Facilitate muscle re-education
- Prevent/retard disuse atrophy
- Maintain or increase joint range of motion
- Increase local blood flow
Contraindications
Patients with a demand-type cardiac pacemaker, defibrillator or any electrical implant should not use the L100 Go System.
Warnings
- The L100 Go System should not be used on a leg where a metallic implant is directly underneath the electrodes.
- The L100 Go System should not be used on a leg where a cancerous lesion is present or suspected.
- The L100 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.
- The long-term effects of chronic electrical stimulation are unknown.
- The Lower Leg 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 L100 Go 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 L100 Go System within three feet of short wave or microwave therapy equipment. Such equipment may produce instability in the EPG output.
- The L100 Go System should only be configured by an authorized clinician.
- In case of any inconvenience, turn off stimulation and remove the Lower Leg Cuff. If the stimulation cannot be turned off, remove the FSC to stop stimulation.
Precautions
- Inflammation in the region of the Lower Leg Cuff may be aggravated by motion, muscle activity, or pressure from the cuff. Stop using the L100 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 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.
- 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 having your clinician change the stimulation parameters, type of electrodes, or electrode placement.
- Do not use the L100 Go System without electrodes.
- After removing the Lower Leg 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 L100 Go System until any inflammation is gone.
- Stop using the L100 Go System and consult your clinician if stimulation does not start at the correct time during gait.
- Turn off the L100 Go System when at a refueling place. Do not use the L100 Go System near flammable fuel, fumes, or chemicals.
- Only your treating clinician should determine electrode placement and stimulation settings.
- Use only the L100 Go System electrodes supplied by Bioness Inc.
- Turn off the L100 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 L100 Go System during pregnancy has not been established.
- Skin problems, on the leg where the Lower Leg Cuff is worn, may be aggravated by the L100 Go System.
- Adult supervision and assistance should be provided for anyone needing help while using the L100 Go System.
- The patient is the intended operator of the L100 Go System.
- Protect all electronic components from contact with water, such as from sinks, bathtubs, shower stalls, rain, snow, etc.
- Do not leave the L100 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 L100 Go System. Contact Bioness if you experience a technical problem not covered in this guide.
- The Lower Leg 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 L100 Go System before putting on the Lower Leg Cuff. Do not turn on the L100 Go System until the Lower Leg Cuff is fastened in place.
- Shut off the L100 Go System before driving, operating machinery, or performing any activity in which involuntary muscle contractions could injure you.
- Protect the L100 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 L100 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. Care should be taken when removing small parts from the system, which may be accidentally swallowed. If swallowed, consult a doctor immediately.
- Do not modify or alter the system in any way and only use Bioness supplied or approved components and parts.
Adverse Reactions
In the unlikely event that any of the following occurs, stop using your L100 Go System immediately and consult your physician:
Signs of significant irritation or pressure sores where the Lower Leg 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 of the Lower Leg Cuff. To promote healthy skin with long-term use of the L100 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 Cuff.
- Replace the electrodes at least every two weeks, even if they appear to be in good condition.
- Wet cloth based electrodes before use and after every 3-4 hours for optimal performance.
- After taking off the Lower Leg 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 Cuff, make sure the electrodes uniformly contact the skin.
- Ventilate the skin by removing the Lower Leg Cuff for at least 15 minutes every three to four hours.
If skin irritation or a skin reaction occurs, stop using your L100 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.
Incident Reporting
Any serious incident that has occurred in relation to the medical 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 L100 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 L100 Go System
Conformity Certification
The L100 Go System complies with Part 15 of the FCC rules. Operation is subject to the following two conditions:
- This device may not cause harmful interference.
- 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 L100 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 L100 Go System before going through airport security. Wear loose clothing so that you can easily show the security person your L100 Go System. The L100 Go System will likely set off the security alarm. Be prepared to remove the L100 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 L100 Go System prescription.
To request a copy of your prescription, contact Bioness or your physician.
Note: The L100 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 L100 Go system in flight.
Electromagnetic Emissions
The L100 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 L100 Go 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 L100 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 L100 Go System before undergoing any diagnostic or therapeutic medical procedure such as Xray examination, ultrasound, Magnetic Resonance Imaging (MRI), etc.
- The L100 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 L100 Go System as replacement parts for internal components) may result in increased emissions or decreased immunity of the L100 Go System.
- The L100 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.