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The WalkAide
System
®
Clinician Manual
INDEPENDENCE
one step at a time
© 2013 Innovative Neurotronics. All rights reserved. All trademarks and registered trademarks
are the property of their respective holders. No part of this manual may be reproduced in any
form without the written consent of Innovative Neurotronics Incorporated. Information in this
LM06-R6
manual is for the use of qualified clinicians only.
Caution: USA Federal Law restricts this device to sale by or on the order of a physician.
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Table of Contents
Troubleshooting
Summary of Contents for Innovative Neurotronics The WalkAide System
- Page 1 INDEPENDENCE one step at a time © 2013 Innovative Neurotronics. All rights reserved. All trademarks and registered trademarks are the property of their respective holders. No part of this manual may be reproduced in any form without the written consent of Innovative Neurotronics Incorporated. Information in this LM06-R6 manual is for the use of qualified clinicians only.
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Page 2: Table Of Contents
Introduction Indications of Use Contraindications Warnings About FES 1.4 WalkAide Specific Warnings Precautions Regulatory Information Adverse Reactions Cautions Glossary Equipment Clinician Kit Patient Kit Demo Kit WalkAide/WalkLink Controls, Indicators & Alarms WalkAide Bi-Flex Cuff Electrode Replacement WalkAide Cuff Disposable Liner 2.8 Symbols and Definitions WalkAnalyst Software Installation WalkAnalyst Upgrades... -
Page 3: Introduction
- The WalkAide should not be worn while receiving any MRI scan. Electrodes - The use of electrodes not supplied by Innovative Neurotronics may diminish results or increase risk of burns or discomfort. Do not place electrodes over open wounds, broken skin or metal objects beneath the skin such as surgical staples. -
Page 4: Walkaide Specific Warnings
1.5 Precautions 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 Heart Disease - Use caution in applying electrical stimulation to persons suspected of having FES electrodes should be removed before defibrillation paddles are applied. heart disease. More clinical data is needed to show that such persons will not experience adverse results. -
Page 5: Adverse Reactions
Innovative Neurotronics submitted the 510(k) to FDA which contained extensive testing and design data, and successfully received 510(k) approval on 09/21/05. Collect Walking Data Collects patient walking data from the Heel Sensor, Hand Switch and/or Tilt Sensor during: Adverse Reactions (1) initial data collection procedures, (2) programmed walking trials in either Tilt or Heel mode, and (3) follow-up walking trials for confirmation of effective walking programs or re- optimization. Skin irritation and burns beneath the electrodes have been reported with the use of nerve stimulators. Do not leave the electrodes in place for long periods of time without checking or Collected Logs cleaning the skin underneath them. - Page 6 Heel and Foot Sensors Save and Analyze There are two types of load bearing sensors: Function that saves and adds the current walking trial as a date and time stamped event (1) The clinician heel sensor is used during data collection and analysis while testing a under Collected Walking Trials. potential WalkAide user. (2) The optional full-length foot sensor is sent home with users whose gait pattern does Save Copy...
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Page 7: Equipment
2.2 Patient Kit analysis and parameter modification in order to correctly time the applied stimulation to the user. The Patient Kit consists of the WalkAide Control Module, WalkAide Electrode Lead Cable, WalkLink and WalkAide User Manual. An appropriately sized WalkAide Cuff is ordered separately and Provides a wireless connection between the WalkAide and a computer, and also allows the full-length Foot Sensor is an optional item. -
Page 8: Walkaide/Walklink Controls, Indicators & Alarms
5. Rapid beeping: Constant beeping with rapid green light flashing indicates the unit was WalkAide/WalkLink Controls, Indicators & Alarms turned on too quickly to a high level, or a new battery was installed without turning off the device. Just turn the device OFF and back ON slowly. 6. Hibernation mode: A non-audible alarm with only a red blinking light indicates hibernation Red visual indicator for error Exercise Button Green blinking light indicates that... -
Page 9: Electrode Replacement
WalkAide Cuff Disposable Liner The cuff must be positioned on the leg correctly to achieve effective and efficient stimulation. Use the Orange visual indicator as a reference for accurate placement of the cuff. Only use The purpose of the Disposable Liner is to provide a hygenic barrier between patient and the the latch to secure and remove the WalkAide. The Velcro strap is adjusted to an optimal level cuff. Additionally, it can shorten preparation time in follow up visits. Each Disposable Liner by your clinician at the initial visit and should not be altered. -
Page 10: Symbols And Definitions
2.8 Symbols and Definitions 4. The WalkAnalyst program will be installed in the Program Files/Innovative Neurotronics directory unless another directory is selected. Meaning of Symbols 5. Once the program has been installed, an icon will be created on the desktop for quick access. WalkAnalyst can also be accessed from the Windows start menu. For detailed Indicates connector location for instruction, refer to WalkAnalyst Installation & Bluetooth Configuration Guide provided... -
Page 11: Changing Clinical Preferences
3.4 Changing Clinical Preferences 4.0 WalkLink Configuration and Bluetooth Pairing WalkAnalyst software allows the clinician to modify default preferences. 4.1 Configuring initial set-up process (Pairing) Clinical preferences: The WalkAide unit default preset A one-time link must be created from the computer to the WalkLink. This is called the “pairing values can be changed to individual process”. -
Page 12: Fitting Process
Note: If the computer and the WalkLink were previously connected: Turn on the WalkLink and open the WalkAnalyst software program. The blue light on the front of the 1. Always prepare the user for the testing procedure by providing a thorough explanation of WalkLink should begin to blink. The WalkAide can be attached to the WalkLink at any the process and always ask for continuous feedback during the procedure. -
Page 13: Electrode Placements And System Preparations
9. Balance the eversion and dorsiflexion movements with very slight shifting of the to indicate that the unit is on. ALWAYS start at a low level of intensity and gradually peripheral nerve stimulator. After determining the most appropriate ‘balance’ point, mark increase during the testing procedure. the location of the posterior black-based node on the leg. This is the starting point for 6. -
Page 14: Fitting A New Patient
• 5.3 Fitting a New Patient Anatomical variations are common. Select Create Patient Profile. Add basic information (patient ID, location, primary diagnosis, etc) and save the patient file. Select Program. During the initial fitting, you have the following programming options: • Rapid+ Program is a simple and easy programming option that can be used by all clinicians. See section 5.5.1 for all the details of Rapid+ Programming. •... -
Page 15: Programming Options
5.5 Programming Options Step 3: Activate Beep on Stim mode. Observe as the patient walks with the newly programmed settings. 5.5.1 Rapid+ Program Adjust the control settings based on clinical observation and patient feedback. Step 1: Select the Rapid+ Program button to initiate programming and initialize the WalkAide device to operate by hand stimulation from the WalkLink. -
Page 16: Standard Program
5.5.2 Standard Program Exercise Settings: Click on the Exercise Settings tab ito adjust patient’s exercise settings. (Figure Select Standard Program (Figure 33) to initiate Standard Programming. Step 1: Enter Patient Information Figure 41: (Adjustment) Exercise settings Usage Logs: Click on the Usage Logs tab to view and/or clear usage data. (Figure 42) Figure 44: (Standard) Patient information Step 2: Clear Usage Logs • The WalkAide collects usage data and gait activity for 69 days since the log start date. -
Page 17: Adjustment
Step 4: Verify WalkAide Settings 1. ‘Zoom’ - Press and hold the left mouse button • This screen captures the current WalkAide and then drag the cursor to select the desired settings. Setting adjustments can be made steps. This ‘Selection’ process will highlight to accommodate specific clinical needs of selected steps to create the most effective a patient. (i.e, Reduce pulse duration for a walking program. -
Page 18: Recover Program
5.5.4 Recover Program TIPS: • If the error rates are greater than 20%: Select Recover if you notice that a patient file is missing for a previously progammed Reset Zoom to see all Data and select a different sequence of steps for WalkAide unit. A patient may also see a clinician at a clinic for a follow-up visit which is Optimization, or different from the one where the patient was originally fitted. Collect a new walking trial for data processing. Repeat the Zoom, Autoset and Optimize procedure. • Connect the WalkAide to a paired WalkLink. -
Page 19: Exercise Mode Settings
TIPS: report this occurrence to your WalkAide clinician. • Slowly work in to full-time wearing of the WalkAide System. How well the user tolerates • The Exercise Mode may be helpful during fitting to verify correct electrode placement. the WalkAide during this break-in period will depend on each individual’s daily regimen and •... -
Page 20: Usage Log
6.0 Evaluation & Reporting Precautions for WalkAide wear: • Skin irritation under the electrodes can occur in a small percentage of FES users. Common WalkAnalyst provides an option to compare a patient’s gait performance with WalkAide versus causes of irritation are use of lotions or perfumed soaps, recent shaving, non-compliance wearing a brace and no assisted device. -
Page 21: Use And Care Of The Walkaide And Accessories
Word version of the report. • Before applying the WalkAide System, the skin must be clean, dry and free from lotions or oils. Any debris on the skin will be transferred to the electrode compromising the adhesiveness and effectiveness of the electrode. -
Page 22: Clinical Troubleshooting
in the same direction the hair lies. Never grasp the cuff and roughly pull away from the leg. onductivity is enhanced by a complete circuit. Assuring a uniform electrode-skin interface. Using a dab of water to separate the electrode from the skin can prolong electrode wear. Apply water to the electrodes (and the skin if desired); make sure that there is no water •... - Page 23 Examples of Threshold Adjustments Control Times (Min, Max, and Wait Time) • Example 1 - Tilt On Threshold is too high (Figure 61). Steps occur on the Tilt graph during which the peak does not reach the On Threshold and therefore stimulation does not occur. Lower the On Threshold to better match the Tilt data in the graph. Figure 64: Control times adjustment in Figure 65: Control times adjustment Figure 61: Tilt on threshold too high...
- Page 24 When testing the WalkAide System on a user with a smaller leg or a child, the Pulse Width should be lowered to 25 prior to testing the system.
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Page 25: Graph Analysis
8.3 Graph Analysis Follow-Up and Re-Optimization The WalkAide System is designed to be part of a progressive rehabilitation program. Many users increase walking speed over time with consistent use of functional electrical stimulation. Other changes in the walking pattern include decreased effort with gait, changes in step and stride length, improved symmetry of stance and swing phases, decreased need for external support (i.e. canes, walkers, crutches), and improved swing phase dynamics. Other... -
Page 26: Technical Troubleshooting
• P rocess the best walking trial by using the Zoom, Autoset and Optimize functions. parameters. (Since this walking data was collected over the user’s existing walking program, the Autoset function is NOT used.) • S end the new walking program to the WalkAide and collect a final walking trial in the Tilt • Mode for verification. Send the new walking program to the WalkAide and collect a final walking trial in “Tilt Mode” for verification. Option 3: Standard Programming, Manual Adjustments: If the user has made moderate changes in their walking ability or if the clinician is planning ahead for changes, then manual adjustments can be made. -
Page 27: Walklink Troubleshooting
Time clock in the WalkAide unit for usage log has stopped working. Need to reconnect to but now messages from WalkAnalyst appear that WalkAnalyst could not find a the WalkAnalyst program to Clear WalkAide Log. configured WalkLink. • Internal time clock battery needs replacing. Contact Innovative Neurotronics. • Turn the WalkLink off and back on, and either choose the first option in the Bluetooth configuration wizard (i.e. Search for Previously Connected WalkLinks) or simply exit and 9. The green light does not flash when the WalkAide is turned ON. -
Page 28: Alternate Pairing Method
Turn off internal Bluetooth of the computer. Internal Bluetooth adapters are FCC class 2 devices with very limited range. Check your computer manual on how to disable internal Bluetooth. If another Bluetooth driver/software is causing the conflict, you may need help from your IT support team. Call the Innovative Neurotronics technical support team if you have trouble resolving this problem. 2. An error occurred while installing the device. -
Page 29: Technical Information
12.0 Contact Information Shipping and Storage Conditions: Device (Long Term) Temperature: -4° – 140°F (-20° – +60° C) Relative Humidity: 95% max., non-condensing If further assistance is required, please contact: Innovative Neurotronics, Inc. Electrodes (Long Term) 3600 North Capital of Texas Hwy, . Temperature: 41° – 80.6°F (5° – +27° C) Bldg. B, Suite 150 Humidity: 35 – 50% Austin, TX 78746 Toll Free (888) 884-6462...