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Innovative Neutronics WalkAide User Manual

Innovative Neutronics WalkAide
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LM01 R9
© 2010 Innovative Neurotronics. All rights reserved. All trademarks and registered trademarks
are the property of their respective holders.

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Innovative Neutronics WalkAide Specifications

General IconGeneral
BrandInnovative Neutronics
ModelWalkAide
CategoryPersonal Care Products
LanguageEnglish

Summary

The WalkAide Stimulator System

Indications of Use

Intended to address foot drop in patients with damage to upper motor neurons or brain/spinal cord pathways.

Contraindications

Lists conditions where the device should not be used, such as with pacemakers or over tumors.

Warnings About FES

Monitoring Equipment Interference

FES may interfere with electronic monitoring equipment like EKG machines.

MRI Safety

The WalkAide should not be worn during an MRI scan.

Electrode Usage and Safety

Use only approved electrodes to avoid burns or discomfort; avoid open wounds.

Pregnancy and FES

Safety of FES during pregnancy has not been established.

Hospital Equipment Interaction

Do not use simultaneously with high-frequency hospital equipment to prevent burns.

Skin Irritation Warning

Improper electrode use can cause irritation or burns; do not use on irritated skin.

Medical Supervision Requirement

FES should only be used under medical supervision of a physician and clinician.

Two-Way Radios Proximity

Be cautious using FES near devices emitting radio frequencies like cell phones.

WalkAide Specific Warnings

Walking and Balance Considerations

Use caution if experiencing dizziness; device does not prevent falls.

Electrode Placement Guidelines

Do not relocate electrode position; never use without electrodes.

Body Placement Restriction

Never use the WalkAide on any body part other than the leg.

Stimulation Behavior Monitoring

Stop use if stimulation is irregular or sensation changes.

Environmental Hazards Warning

Not intended for use in flammable environments like those with oxygen or anesthetics.

Impact and Handling Caution

Minimize excessive impact to the control module; avoid standing/kneeling on it.

Precautions

Heart Disease Caution

Use caution in persons with suspected heart disease; more data needed.

Sensory Deprivation Risk

Use caution on skin with reduced response due to burn risk.

Child Safety

FES devices should be kept out of the reach of children.

Epilepsy Caution

Use caution in persons with suspected epilepsy; more data needed.

Recent Surgery Restriction

Do not use following recent surgery where muscle contraction may disrupt healing.

Skin Preparation for Electrodes

Do not use lotion or oil where electrodes contact skin; ensure good contact.

Proper Use and Maintenance

Proper use is key to safety/efficacy; check accessories, secure electrodes.

Operating Equipment and General Safety

Adverse Reactions: Skin Irritation

Reported with FES; check skin, do not use on irritated skin. Notify doctor if persistent.

Operating Dangerous Equipment

Do not use while operating dangerous equipment due to potential stimulation changes.

Sleeping and Bathing Restrictions

The WalkAide should not be worn or used while sleeping or bathing.

Heat and Cold Application Caution

Avoid heat/cold devices near electrodes; consult doctor before use with FES.

Foot Sensor Socket Restriction

Do not plug foot sensor into any electrical socket other than WalkAide.

Cautions and Handling

General FES Use Rules

Use under clinician instruction, avoid hazardous situations, ensure proper operation.

Unit Handling and Environment

Handle carefully, avoid water, excessive heat, vibration; do not drop unit.

Accessory and Battery Cautions

Use only approved accessories; do not open unit except to replace battery.

Sitting Posture Guideline

Turn OFF the unit if sitting for an extended period of time.

Symbols and Definitions

Device Symbols Reference

Explains various symbols used on the device and in the manual, like Type BF Equipment and Error Signal.

Key Indicator Definitions

Defines indicators for battery, stimulation, and connectors.

WalkAide Controls and Indicators

Top View Controls Overview

Details the Intensity Knob, Exercise Button, STIM Button, and indicator lights.

Audible Alarms Explained

Explains different audible alarms for low battery, sensor connection, and device errors.

Unit Views and Connector Identification

Identifies output connectors, battery compartment, and WalkLink connector on different views.

General Operating Instructions

Application and Removal Ease

Designed for single-handed application/removal; can be worn under clothing.

Clinician Setup and Electrode Placement

Clinician sets optimal stimulation areas and electrode placements on the initial visit.

Applying the WalkAide

Skin Preparation for Application

Ensure skin is clean and free of lotions for proper contact and stimulation.

Unit Preparation Before Use

Ensure unit is OFF and Intensity Knob is at O before handling.

Leg Positioning and Moisture

Sit with leg extended, moisten electrodes and correct position below knee.

Cuff Placement Accuracy

Position cuff correctly using visual indicator for effective stimulation.

Applying the WalkAide (Continued)

Foot Sensor Connection Procedure

Connect foot sensor if provided to the marked side of the unit.

Turning On and Intensity Adjustment

Turn unit ON, check for green light, adjust intensity to clinician's level.

Testing Stimulation and Foot Movement

Press STIM button to check intensity and foot movement quality.

Walking with the WalkAide

Stand and walk; can be used with or without shoes, but proper footwear is recommended.

Removing the WalkAide and Skin Care

Unit Storage Instructions

Place plastic backings on electrodes, store in a resealable bag away from sunlight.

Skin Care Recommendations

Check skin before/after use, gently remove electrodes, avoid irritated areas or lotions.

Instructions for Exercise Mode

Exercise Mode Usage Guidelines

Designed for stimulation while at rest, not for walking. Apply repeated stimulation.

Starting Exercise Mode Procedure

Assume sitting position, adjust Intensity Knob, press Exercise Button for >3 seconds.

Battery Management and Replacement

Battery Life and Indicators

Expected battery life is ~42 hours; low battery indicated by flashing lights and beeps.

Battery Replacement Procedure

Turn unit OFF, open compartment, replace with a single alkaline AA battery; do not use rechargeables.

Changing the Electrodes

Electrode Replacement Frequency

Electrodes should be changed approximately every 1-2 weeks or upon excessive wear.

Electrode Connection Guide

Disconnect old leads, place new electrodes, connect BLACK to BACK, RED to FRONT.

Maintenance and Cleaning Procedures

Unit Maintenance Requirements

Unit requires no user maintenance beyond battery replacement; refer servicing to clinician/manufacturer.

Cleaning the WalkAide Unit

Wipe unit with rubbing alcohol or mild detergent; do not use bleach or immerse in water.

Storing the WalkAide Device

Remove battery if storing for extended periods to conserve power.

Washing the WalkAide Cuff

Hand wash cuff liner, do not use bleach, line dry only; do not remove locators.

Device Disposal Guidelines

Dispose of the device properly according to local and national regulations.

Troubleshooting-Frequently Asked Questions

Indicator Lights Not Functioning

Likely low battery voltage. Replace battery and check again.

Error Message: Green Blinking, Red On

Indicates an error message. Turn unit off and on again.

Troubleshooting Insufficient Foot Lift

Check intensity, electrodes, and contact area. Consult clinician if still insufficient.

Stimulation Timing Issues

May indicate cuff shift or walking pattern change. Consult clinician for adjustments.

Lotion and Oil Use on Skin

Do not apply lotions/oils to electrode area. Keep leg clean and moist.

Troubleshooting and Clinician Contact

Electrode Lifespan Expectation

Electrodes should be changed approximately every 1-2 weeks or upon excessive wear.

Battery Lifespan and Indicators

Each AA battery lasts 1-3 weeks. Low battery indicated by flashing lights and beep.

WalkAide Accessory Storage

Store accessories in a resealable bag to prevent electrodes from drying out.

WalkAide Status Indicator

A green blinking light near the Intensity Knob indicates the unit is on with adequate battery.

When to Contact Your Clinician

Contact clinician for questions, condition changes, accessory wear, errors, or irritation.

Wearing Schedule and Break-In

Break-In Period Schedule

Provides a schedule for increasing ON time and decreasing OFF time over 14 days.

Skin Integrity Checks During Wear

Check skin every 2 hours; remove cuff at intervals to inspect skin under electrodes.

Skin Preparation for Wearing

Do not use lotions/oils; ensure skin is clean and try prior to applying cuff.

Shaving and Irritation Management

Shave in evening to prevent irritation; reduce wear time if soreness occurs.

Electrode Moistening and Replacement

Wet electrodes before use; change every 1-2 weeks, cover with backing tabs.

WalkAide User Statement of Understanding

Patient and Practitioner Agreement Form

Form for patient to review manual, understand instructions, and agree to follow wearing schedule.

Medical Device ID Card Information

Patient Identification Card Details

Details for a patient ID card including name, practitioner, and device information.

Technical Information

Reference Part Numbers

Lists part numbers for various WalkAide kits, components, and accessories.

Technical Specifications and Support

Device Specifications Overview

Details size, weight, power source, current, voltage, channels, pulse type, and width.

Operating and Storage Conditions

Specifies temperature, humidity, and altitude limits for device operation and storage.

Ratings and Expected Service Life

Provides IEC rating and expected service life of the device.

Manufacturer Contact Information

Provides contact details for Innovative Neurotronics for further assistance.