Precautions for Use of the NESS L300 Foot Drop System

• Inflammation in the region of the NESS L300 may be aggravated by motion, muscle activity, or pressure from the Functional Stimulation Cuff (Orthosis). Use of the device should be temporarily halted until the inflammation is resolved completely.
• Caution should be used in patients with suspected or diagnosed heart problems.
• Caution should be used in the presence of the following conditions in the area of the Functional Stimulation Cuff (Orthosis):
  • When there is 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.
• Caution should be used for patients with suspected or diagnosed epilepsy.
• Some patients may experience skin irritation or hypersensitivity due to the electrical stimulation or electrical conductive medium. The irritation can usually be reduced by changing the stimulation parameters or alternate electrode placement (performed by the treating clinician).
• Electrode placement and stimulation setting should be determined by the treating clinician.
• The NESS L300 should be used only with electrodes supplied by Bioness Neuromodulation Ltd. or Bioness Inc.
• Specific physician clearance should be obtained prior to use in patients with alteration of normal arterial or venous flow in the region of the Functional Stimulation Cuff (Orthosis) due to local insufficiency, occlusion, arterio-venous fistula for the purpose of hemodialysis, or a primary disorder of the vasculature.
• Specific physician clearance should be obtained when there is a structural deformity in the area to be stimulated.
• The safety of the NESS L300's use during pregnancy has not been established.
• Skin problems in areas of contact with Functional Stimulation Cuff (Orthosis) may be aggravated by use of the NESS L300.
• The NESS L300 should be turned off before removing or replacing the electrodes.
• The NESS L300 should be kept out of the reach of children.
• The NESS L300 Control Unit is splash proof. However, it should be protected from any contact with water, such as water from sinks, bathtubs, and shower stalls, from weather such as rain or snow, or any other source of water.
• Do not leave the NESS L300 stored in a car in hot or cold weather where the temperature may exceed the recommended storage temperatures of -20 to 60°C (-4 to 140°F) and could cause damage to the device.
• Should any technical problem occur that is not covered in the Troubleshooting section of the NESS L300 User's Guide, contact Bioness Inc. Do not attempt to repair the NESS L300.
• The Functional Stimulation Cuff (Orthosis) is meant to be worn only on the leg of the patient for whom it is fitted. It should not be applied to anyone else or any other part of the body.
• Put on the Functional Stimulation Cuff (Orthosis) only when the NESS L300 is turned off. Do not activate it until it is fastened in place.
• The system should be shut off while driving, operating machinery, or during any activity in which involuntary muscle contractions may put the patient at undue risk of injury.
• Medical electrical equipment needs special precautions regarding Electromagnetic Compatibility (EMC).
• In order to avoid condensation problems, when moving the NESS L300 between hot and cold temperatures, place the NESS L300 in an airtight plastic bag and let it slowly adjust to the temperature changes (at least 2 hours) before using the system.