Below is a list of Indications, Contraindications, and general Warnings and Cautions related to the use of Walkasins® Lower Limb Sensory Prosthesis. All Warnings and Cautions pertaining to specific functions or procedures are included throughout the Walkasins Instructions for Use available with the product and from RxFunction at 888.382.3518.

Intended Use / Indication for Use

Walkasins is an external lower limb sensory prosthesis intended to replace the nerve function used for detection and signaling of foot pressure sensation.

Walkasins is indicated for patients with lower limb sensory peripheral neuropathy who present with gait and balance impairments. Walkasins is indicated for patients who can feel the tactile stimuli from the Haptic Module on the lower leg.

Walkasins is contraindicated for:

• Untreated lymphedema;
• Untreated lesion of any kind, swelling, infection, inflamed area of skin or eruptions on the lower leg near product use;
• Acute thrombophlebitis including deep vein thrombosis;
• Untreated fractures in the foot and ankle;
• Severe peripheral vascular disease.

Warnings

WARNING: Do not let small children or pets play with or operate Walkasins. Walkasins contains small parts that can be inhaled or swallowed by children or pets causing choking. Children or pets can damage Walkasins.

WARNING: Use only the RxFunction cable for charging the Haptic Module. Do not leave Walkasins near unattended young children and pets due to the increased risk of strangulation.

WARNING: Use of accessories, transducers and cables other than those specified or provided by RxFunction could result in increased electromagnetic emissions or decreased electromagnetic immunity of Walkasins, and result in improper operation.

WARNING: Use of Walkasins adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, Walkasins and the other equipment should be observed to verify that they are operating normally.

WARNING: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of Walkasins including cables specified by RxFunction. Otherwise, degradation of the performance of this other equipment could result.

WARNING: Use only the power adapter and power adapter cable supplied by RxFunction. Use of other power adapters or cables may increase the risk of electrical shock.

Precautions

CAUTION: Always monitor your lower legs for changes to the skin. The long-term effects of persistent low-intensity vibrations to the skin are unknown.

CAUTION: Do not rely solely on Walkasins to maintain balance. Walkasins cannot prevent falls.

CAUTION: Do not place Walkasins over damaged skin or open wounds. Placing Walkasins over damaged skin could cause further skin damage.

CAUTION: Do not overload Walkasins. Walkasins has been tested for individuals weighing up to 300 lbs. (136 kg). Overloading may decrease performance.

CAUTION: Do not immerse Walkasins in water or use them where they can get wet such as in the shower, bathtub, swimming pool or washing machine. The Haptic Module and Receptor Sole are not waterproof and may stop working.

CAUTION: Do not allow Walkasins to be used by any person for whom it was not prescribed to limit the risk of cross-contamination.

CAUTION: Stop using Walkasins if experiencing increased pain or discomfort as a result of using Walkasins to avoid the risk of injury. Notify the prescribing healthcare team member of any pain or discomfort.

CAUTION: Stop using Walkasins immediately if any lesions, severe swelling, infections, or inflamed areas of the skin occur. Contact your healthcare provider and resume use only as directed.

CAUTION: Place the Receptor Sole flat. Never place the Receptor Sole over visible debris or kinks, as this will interfere with the operation of the device or could lead to skin damage.

CAUTION: Do not place Walkasins over damaged skin or open wounds as doing so could cause further skin damage.

CAUTION: Do not over-tighten the Haptic Module Strap. Over-tightening the strap can reduce blood flow and cause injury.

CAUTION: Properly secure the Haptic Module Strap to avoid the Haptic Module becoming disconnected. A disconnected Haptic Module Strap during use can be a tripping hazard.

CAUTION: Do not attempt to modify, service, or repair Walkasins.

CAUTION: Never connect the Power Adapter and Power Adapter Cable to Walkasins while wearing the device. Walkasins does not function when charging, and the cable presents a tripping hazard.

CAUTION: Never use heat or any household chemicals to clean Walkasins.

Skin Care Guidelines

Reduced sensation in the feet from peripheral neuropathy places you at a higher risk for skin injury. Careful attention to proper skin care with Walkasins use is essential.

Always follow skin care recommendations provided by your healthcare team.

Recommendations for proper skin care:

• Always check for signs of skin irritation on your foot and lower leg when putting on and taking off Walkasins.
• Never place the Receptor Sole or the Haptic Module over irritated or damaged skin.
• Wearing socks (cotton or other natural fibers) during Walkasins use may help protect skin integrity.
• Ensure the Haptic Module fits comfortably and snugly without being too tight throughout use.