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Below is a list of Indications, Contraindications, and general Warnings and Cautions related to the use of Walkasins. 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 Leg Unit on the lower leg.
Contraindications

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 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 Leg Unit. 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 this equipment and result in improper operation.

WARNING: Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment 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 the lower legs for changes to the skin. 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, bath, swimming pool or washing machine. The Leg Unit and Foot Pad 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 the experiencing increased pain or discomfort as a result of using Walkasins to avoid risk of injury. Notify the prescribing healthcare team member of any pain or discomfort.

CAUTION: Place the Foot Pad flat. Never place the Foot Pad 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 Leg Unit Strap. Over-tightening the Strap can reduce blood flow and cause injury.

CAUTION: Properly secure the Leg Unit Strap to avoid the Leg Unit becoming disconnected. A disconnected Leg Unit 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

Without proper skin care, extended use of Walkasins may lead to skin irritation or damage. Wearing socks (cotton or other natural fibers) underneath both the Walkasins Leg Unit and Foot Pad is recommended in order to protect skin integrity.

Always check for signs of skin irritation on your foot and lower leg when putting on or taking off Walkasins. You should never place the Foot Pad and the Leg Unit over irritated or damaged skin.

Throughout use, ensure the Leg Unit provides a comfortable and snug fit without being too tight. Adjust the Leg Unit strap as needed.
If skin lesions, severe swelling, infections, or inflamed areas of the skin occur, stop using Walkasins. Contact your healthcare team immediately. Resume use as directed by your healthcare team.

Always follow skin care recommendations provided by your healthcare team.