4
5
Defibrillator
- External defibrillation of a person wearing a FES device can damage the
device or injure the user even when the device is turned off. Under some circumstances there
may be risk of burns under the electrode sites during defibrillation. To eliminate any risk, the
FES electrodes should be removed before defibrillation paddles are applied.
Chronic Stimulation
- Effects of long term chronic stimulation are unknown in this particular
application.
1.4 WalkAide Specific Warnings
Walking
- Care should be taken when using the WalkAide for people who experience
dizziness or have difficulty maintaining balance. The WalkAide is not designed to prevent
falling. Assess user’s condition for inability to walk or balance.
Electrodes
- The user should not relocate the position of the electrodes within the cuff. Do
not use the WalkAide without electrodes.
Placement
- Never use the WalkAide on any area of the body other than the leg.
Stimulation
- Stop using the WalkAide if stimulation does not come on at the appropriate time
when walking and/or there is a change in the sensation perceived while the stimulation is on.
Environment
- WalkAide and WalkLink are not intended for use within flammable
environments such as oxygen and anesthetics.
Impact
- Care should be taken to prevent excessive impact to the WalkAide Control Module.
This includes standing or kneeling on the unit, or impact from any hard surfaces.
WalkLink
1. FCC Part 15 notice:
This device complies with Part 15 of the FCC Rules. Operation is subject to the following
two conditions: (1) This device may not cause harmful interference, and (2) this device
must accept any interference received, including interference that may cause undesired
operation.
2. FCC Radiation Exposure Statement for Portable Devices
This equipment complies with FCC radiation exposure limits set forth for an uncontrolled
environment. This equipment is in direct contact with the body of the user under normal
operating conditions. This transmitter must not be co-located or operating in conjunction
with any other antenna or transmitter.
3. The user is cautioned that changes or modifications not expressly approved by the party
responsible for compliance could void the user’s authority to operate the equipment.
1.5 Precautions
Heart Disease
- Use caution in applying electrical stimulation to persons suspected of having
heart disease. More clinical data is needed to show that such persons will not experience
adverse results.
Sensory Deprivation
- Use caution when placing electrodes on areas of the skin with
reduced response to normal sensory stimuli, due to the risk of skin burns.
Children
- FES devices should be kept out of the reach of children.
Epilepsy
- Use caution in applying electrical stimulation to persons suspected of having
epilepsy. More clinical data is needed to show that such a person will not experience adverse
events.
Recent Surgery
- Do not use FES following recent surgery where muscle contraction may
disrupt the healing process.
Electrodes
- Do not use lotion or oil in the area that the electrodes make contact with the
skin. Stimulation may not be effective.
Proper Use
- The safety and efficacy of FES depends on the proper use and handling of
the FES system. Improper use of the device or electrodes can result in injury to the user.
Regularly check accessories for wear and replace as needed. Electrodes should be firmly
secured to the skin. Never use the WalkAide if it appears to be malfunctioning. If there
is a change in the way it usually works (i.e. change in sensation, surging of stimulation,
intermittent stimulation) do not use the WalkAide and contact Innovative Neurotronics
immediately.
Operating Equipment
- The stimulator should not be used while operating potentially
dangerous equipment such as automobiles, power lawn mowers or large machinery. Abrupt
changes in stimulation level could create a hazard.
Sleeping
- The WalkAide should not be worn or used while sleeping or bathing.
Heat and Cold - The use of heat or cold producing devices such as electric blankets, heating
pads or ice packs may affect the electrodes or the person’s circulation and increase the risk of
injury. A medical doctor and clinician should be consulted before using with FES.
Caution
- Do not plug foot sensor into any electrical socket other than WalkAide.
Caution
- Do not unplug foot sensor while sensor is in the shoe.
1.6 Regulatory Information
FDA is the regulatory agency that governs the process of testing and approval of medical
devices. The WalkAide has been classified as a Class II medical device, requiring FDA
510(k) approval of device safety and the effectiveness of the device prior to marketing.
