Table of Contents Definition of Symbols ........................ 6 Before Proceeding ........................7 Important Safety Information ..................... 8 Biodex Warranty ........................10 Introduction ........................12 Intended Use ........................ 12 Indications for Use ....................... 12 ...
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References: ........................ 102 P arts and Assembly Illustrations ..................104 Appendix A: CSV File Export ....................109 Appendix B: Use of Music Therapy and the Biodex Gait Trainer ..........114 GAIT TRAINER 3 (v3.X SOFTWARE)
Before Proceeding NOTE: The warnings, cautions and instructions provided in this manual must be read, followed and kept available for consultation at all times. Observing the information, instructions, and procedures presented throughout this manual is essential for using this product both properly and safely. SPECIFIC CAUTIONS Allow only qualified, trained personnel to operate or service this product.
For electromagnetic compliance definition, refer to the Table of Contents. Reference Cleaning and Maintenance instructions in Table of Contents. CAUTION: Operation for 950-400: 115 VAC; 950-401: 230 VAC; 950-404: 100 VAC. ATTENTION: Opération pour 950-400: 115 VAC; 950-401: 230 VAC; 950-404: 100 VAC.
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CAUTION: To avoid risk of electric shock, this equipment must only be connected to supply mains with protective earth. ATTENTION: Pour éviter le risque de choc électrique, cet équipement doit uniquement être connecté à un approvisionnement conduites avec la terre protectrice.
BIODEX MEDICAL SYSTEMS, INC. During the warranty period, BIODEX MEDICAL SYSTEMS, INC. will in its sole discretion, repair, send replacement parts, or replace the equipment found to have such defects at no charge to the customer.
7. After analyzing the problem, we will decide if the unit can be repaired on site, or replacement parts will be sent. 8. If the unit must be returned, Biodex will provide a return materials authorization number (R.M.A. #.) Pack the unit in the carton that it was originally shipped in. It is the customer's responsibility for any damage that occurs during shipping.
Printer Installation 1. Refer to the supplied printer manual to unpack the printer and ensure that it has not been damaged by shipping. 2. Position the printer on the Biodex-provided printer stand. GAIT TRAINER 3 (v3.X SOFTWARE)
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3. Locate the printer power cable. Plug the small end into the power receptacle on the back of the printer. 4. Insert the AC plug end of the printer power cable first into the Biodex-provided power adapter, and then insert the adapter plug into the power cable receptacle on the back, lower base of the Gait Trainer 3.
For help with this, please call Biodex Customer Support at 631-924-9000, Option 3. Similarly, any Windows 7 keyboard or mouse will automatically connect using one of the USB connections.
2. Gait Trainer Mode The Biodex Gait Trainer can be used for gait training applications or as a rehabilitation treadmill. The following section describes use in the Gait Trainer Mode. The rehabilitation treadmill operation is described later in this manual.
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Figure 2.2. The Gait Trainer Patient Setup screen. Figure 2.3 The Gait Trainer Patient Setup screen. The presence of certain icons (e.g., the Diagnosis and G-Code icons) are set within system Utilities. Similarly, the different ways to input height, weight, and age information can also be configured in system Utilities.
Additional Gait Training Patient Setup Screen Parameters NOTE: The following parameters are only visible when they are activated within the Gait Trainer Configuration settings (i.e., in system Utilities.) G-Code Options (Figure 2.10.): Touch <G-Code> to apply certain G-Code settings to this ●...
Set Step Length Tolerance Range: Touch <Set Range> and use the pop-up keypad to ● increase or decrease the distance between the target lines the patient must achieve in the steps they take. Set Visual Biofeedback ON/OFF Interval Time: Touch <ON>, <OFF>, or <Interval> and ●...
The G-Code Calculator Options Screen Figure 2.10. The G-Code Calculator Options screen. The G-Code Calculator Options screen contains three drop-down menus that will apply various types of G-Code data to the patient’s tests. The G-Code result options and categories are discussed in depth in a later section of this document.
Footfalls/Histogram Screen Parameters Touch <Next> at the Patient Setup screen to advance to the Footfalls/Histogram screen. At this screen, users can view patient progress via either a footfall or histogram display. Touch the appropriate icon at the bottom of the left to toggle between display formats. With either display, the following parameters can be adjusted at any time as follows: Walking Speed (mph): Located at the top right of the screen.
NOTE: Clarification of Normative Data for the Gait Trainer: The normative data and goals presented in the Biodex Gait Trainer are derived from the reference tables in Gait Analysis, An Introduction, 2nd. Edition, Michael W. Whittle, 1997, pgs. 218 - 219.
Test Results Screen Functions From the Test Results screen the user can perform the following functions: Back: Return to the Footfalls/Histogram screen by touching <Back>. All current exercise data will be lost if <OK> to proceed is touched. To cancel and return to the Test Results screen, touch <Cancel>.
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Figure 4.6. Select Progress Report, and Reports on the following screen. Figure 4.7. Touch the progress parameters that you are interested in viewing and/or printing. Green boxes indicate selected parameters. Also, choose to have data points on the report and/or Normative data ranges. Figure 4.8.
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Figure 4.12. In this case, the progress report shows an increased step length variability over the sessions. Figure 4.13. Progress report showing the percentage of time spent on each foot. GAIT TRAINER 3 (v3.X SOFTWARE)
Associating G-Code Data The G-code screen is accessed from the Patient Setup screen in the Gait Trainer interface. Touch the <G-code> icon to access this screen. Figure 5.2. Patient Setup screen in the Gait Trainer interface. Using the G-code icon, a user can access the drop-down menus needed for associating G-code data.
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The G-code category drop-down menu features a list of commonly used rehabilitation categories. The category most likely to be associated with the Gait Trainer is the Mobility: Walking and Moving Around selection. Figure 5.5. The second drop-down menu on the G-code Calculator Options screen in the Gait Trainer interface allows the user to choose a G-code category.
Figure 5.9. The Patient Setup screen after G-code data has been associated. Test Results Data Exercise report data can be reviewed from the Test Results screen only after touching <End> to end the exercise session and touching <Results>. The Test Results screen can also be accessed by selecting the individual record from the Reports section in system Utilities.
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Figure 5.12. Sample graph showing how the Gait Trainer software calculates Impairment Percentage. From the Stored Test Results screen, the therapist may also choose to alter the Impairment Percentage numbers manually. To do so, touch the number to be changed. Figure 5.13.
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Enter an updated number with the keypad. Two things can be observed when the Stored Test Results screen is redisplayed: First, a red asterisk has appeared next to the updated number marking it as being amended. Also, since the impairment level change was a significant one — from 0 to 33 — the Severity Modifier Code has changed from CH to CJ.
6. Treadmill Operation Figure 6.1. The Quick Start feature allows the user to begin the exercise session with minimal input. Quick Start Operation Although the Gait Trainer offers advanced programming capability, it also features a "Quick Start" function that allows the user to immediately begin exercise on the system with 1/4-mile scaled track views.
Heart Rate: Displayed at the top of the screen, this is the real-time heart rate of the user during the exercise session measured using the contact handgrips. Quick Setting Option for Speed Value: Clinicians and users have the option of bringing the treadbelt to a designated speed without having to press the <▲>...
7. Treadmill Profiles The Biodex Gait Trainer treadmill mode features five pre-loaded exercise profiles and the ability to create and select up to 12 custom exercise profiles. These programs allow the clinician to select pre-determined exercise format routines. Exercise profiles are divided into as many as ten segments each.
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Figure 7.1. The Select Profile screen allows the user to choose from five pre-defined profiles. Figure 7.2. At the Profile Setup Options screen, users can enter values for time, body weight and maximum elevation. GAIT TRAINER 3 (v3.X SOFTWARE)
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Figure 7.4. At the Editing Profile screen, clinicians enter values for speed, elevation and time for each of up to ten stages for any profile. GAIT TRAINER 3 (v3.X SOFTWARE)
Configuration Figure 8.3. Configuration – Utilities Screen To advance to the Configuration screen from the Utilities Menu, touch <Configuration>. There will be a submenu featuring two icons; one for System Configuration and one for Gait Trainer Configuration. For either option, the user must enter 159 at the “Access ID Code” prompt and touch <OK>.
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Figure 8.6. Set the System Date/Time Screen Tone Volume: Touch any section of the horizontal bar to select a new tone volume setting. Selecting low numbers along the bar will result in lower volume while selecting high numbers makes the louder. Tone volume settings range from 0 to 10. Change Access ID Code: Users can change the default Access Code (159) used to access secure settings in the device software.
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Figure 8.9. Clinical Codes Screen. Figure 8.10. Patient Setup screen with Clinical Codes (CPT) option activated. Normative Data Configuration: Normative data can be specified to each facility’s needs. Select a particular row of demographic information and touch the pencil icon beside the row to edit the norms for performance in the settings at the bottom of the screen.
3. The user may also edit the data in the Additional Information screen. On this screen, the user can add details regarding the facility where the patient is being treated or create customized drop-down menus to name two options. 4. After editing the patient information, touch <OK>. The file is saved with the changes and the system returns to the Patient Management –...
Figure 8.19. The Multiple Patient Data Export screen. 1. From the Patient Management – Select a Patient screen, touch <Export Multiple>. 2. On the next screen, the user has the option to select what range of patient records to export: All records, records from a certain date to present time, records prior to a certain date, or all records between certain dates (From/To).
Figure 8.21 illustrates that the BioReports folder is just one of several subfolders that are automatically generated in the main GaitTrainer4 directory, which is automatically generated by the system. Here is a list of the subfolders, along with the types of files they contain: BioBackup: The backup of system settings with database.
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Figure 8.25. Restore from USB Screen. The Select Backup to Restore screen displays a list of backed up databases that have been created. The most recently backed up database will be the top row of the list. Select the database to restore as the Gait Trainer’s current data set, and select the <OK> icon. The Database Restore Complete screen is displayed as illustrated below: Figure 8.26.
Figure 8.28. Advanced System Maintenance Screen. Advanced System Maintenance Screen Settings Treadmill Diagnostics: The Treadmill Diagnostics screen allows the user to conduct some diagnostic tests with regards to treadmill performance. The strain gauges can be reset to the factory calibration and the strain gauge board can be re-initialized. Touch <...
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Figure 8.32. Event Log Screen. Reset Application Settings: Use this function to return all application settings to factory defaults. Patient data will not be deleted a reset is performed. Figure 8.33. Reset Application Settings Screen. Language: Use this function to set a language preference for the system. Product Type: The product type can be designated as either Gait Trainer or RTM 600.
From time to time, it may be necessary to update the device’s software. The steps for updating the software are as follows: 1. Download the updated software from www.biodex.com to a portable thumb drive. Be sure to save the file in the root directory of the drive.
9. Music Therapy The Biodex Gait Trainer 3 with version 3.X software can be configured with an optional Music Therapy component (see Appendix B for a treatise on the use of music therapy in relation to the Biodex Gait Trainer). The Music Therapy option includes a specially designed bracket to hold the provided sound bar and a USB drive that activates the music player software and the music therapy music files.
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Figure 9.4. The sound bar’s power and sound cables (arrows). The Music Therapy component will not be activated until the flash drive is inserted into one of the USB ports on either the side or the bottom of the display. (The location of USB ports may vary depending on the display model.) The software will activate automatically once the flash drive is inserted.
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“Music” button in the lower left corner. During an initial assessment, a Music Therapist assesses the patient's gait with either an over- ground session (10 meter walk test) or if they have the Biodex Gait Trainer, with a standard Gait Trainer mode session—no music.
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In this example, the 72 BPM version of the song “Street Walking” is selected. Figure 9.8. Setting the Beats per Minute (BPM) To match the BPM of the song with the steps per minute reading on the left, touch the “up” <Metronome>...
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in application than Rhythmic Auditory Stimulation (RAS), because it is (a) applied to movements that are not rhythmical by nature (e.g., most arm and hand movements, functional movement sequences such as dressing or sit-to-stand transfers) and (b) it provides more than just temporal cues.
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On the Music Therapy screen when <Select Song> is touched, the contents (audio files) of the currently inserted flash drive are displayed. If the Biodex flash drive is inserted, a library of songs composed specifically for music therapy will be displayed. A different flash drive can be inserted (although not at the same time) and the software will display any audio files that are in the flash drive’s root directory.
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baseline tempo will be unknown and will need to be entered for tempo control to work correctly. For each song with no tempo identified, enter the tempo (in this case 80 BPM [Beats Per Minute]) and touch <OK>. Figure 9.13. Entering a song’s tempo (BPM). The Controls work as follows: Play: Starts the song and, if already playing, will pause the music.
A more comprehensive clinical guideline for music therapy protocols will be available to help guide a music therapy program. Visit www.biodex.com or email clined@biodex.com for more information. The music therapy component of the Gait Trainer 3 should only be utilized by a credentialed music therapist.
10. Maintenance The Biodex Gait Trainer 3 should provide trouble-free operation as long as the following maintenance procedures are performed. To verify hours of operation, touch <Utilities> and touch the right-left-right sequence on the main system Utilities screen to activate the <Advanced System Maintenance>...
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Figure 10.1. Main Screen Figure 10.2. Main Menu, followed by right-left-right touches to activate Advanced System Maintenance button. GAIT TRAINER 3 (v3.X SOFTWARE)
3. Allow the Gait Trainer 3 to dry for approximately ten minutes. NOTE: Use only the Biodex lubricant kit with the Gait Trainer 3. Most standard greases, waxes and silicon sprays will build up on the rollers causing belt slippage and affecting tracking.
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2. Access the Quick Start Treadmill function and adjust the speed to 1.0 MPH. Figure 10.6. Quick Start Treadmill Screen 3. Walk on the treadmill at 1.0 MPH and stop the treadbelt with a foot. Front roller should slip under the treadbelt .
NOTE: The above faults indicate an issue with the treadmill. For fault 64-Safety Lanyard Removed, verify lanyard is still attached in its proper location. For all other faults, please contact Biodex Support Services department at 1-800-224-6339 and provide the fault code. Someone will provide instructions on how to proceed.
Declaration of Conformity Manufacturer’s Declaration Electromagnetic Emissions The Gait Trainer 3 is intended for use in the electromagnetic environment specified below. The customer or the user of the Gait Trainer 3 must ensure that it is used in such an environment.
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Immunity IEC 60601-1-2 IEC 60601-1-2 Electromagnetic Test Test Level Compliance Environment -Guidance Level frequency of the transmitter. Recommended separation distance: d = 1.2√ P 150 KHz to 80 MHz d = 1.2√ P 80 MHz to 800 MHz d = 2.3√ P 800 MHz to 2.5 GHz Where P is the maximum output power rating of the transmitter in watt (W)
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CHIU, CC, et al. INFLUENCING FACTORTS AND AMBULATION OUTCOME IN PATIENTS WITH DUAL DISABILITIES OF HEMIPLEGIA AND AMPUTATION Arch Phys Med Rehabil, Vol. 81, Jan 2000 Biodex #91-144 DEAN, CM, et al. TASK-RELATED TRAINING IMPROVES PERFORMANCE OF SEATED REACHING TASKS AFTER STROKE, Vol.
Appendix A: CSV File Export From the Gait Trainer application, two types of CSV files can be exported: Single (Individual) test record CSV • Multiple test record CSV file. • A Single CSV file will contain all of the data for an individual test along with raw data points.
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Field Heading Description left leg. RtVariance Coefficient of variation displayed as a percentage for the Right Leg. LtVariance Coefficient of variation displayed as a percentage for the Left Leg. RtTimeDistrib The time spent on the right foot displayed as a percentage. LtTimeDistrib The time spent on the left foot displayed as a percentage.
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The file starts with the basic information about the patient/test performed, after which it contains the actual scores/data for the test result. A more concise illustration of the exported file is presented in Figure A.2 below: Figure A.2. CSV File Format Explanation – A More Concise Illustration of the Exported File. The first record within the exported CSV file illustrates values of AvgSpeed = 0.25 and the normative data minimum and maximum for this category as 0.96 and 1.68 respectively (see Figure A.3 extracted from the Test Results screen that matches the exported CSV file value).
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Patterned Sensory Enhancement (PSE) A broader application than RAS as it facilitates movement and movement patterns that are not biologically rhythmical. These movement patterns are incorporated into a series to form functional movement patterns. For example, hand and arm movements for eating, dressing, and other ADL’s as well as whole body movements required to shift from a seated to as standing position.
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Everywhere: 45-108 Initial Contact/ Metronome/Bass Drum • Constant music (heelstrike) • Facilitates heel strike 45-108 BPM Initial Contact Bass guitar • A crisp sound with greater force assists with Metronome/Down (heel strike) increasing stride length beat of songs • tends to get people to stroll •...
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Music Samples from compositions designed for use in Biodex GT3 Systems Animals Everywhere (gentle forward-pulling sensory experience throughout piece): BPM: Time: Activity: 45 BPM: Guitar pattern for leg lift, extension and drum playing down beat for consistent heel strike from beginning through end of song.
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72 BPM: 0:00 - Heel strike first. 0:26 1:19 Gentle pushing quality to sensory pattern, builds movement up then backs off and gives anticipatory cues for more complex UE/LE complex coordination. 2:13 Integrate texture for full hip extension and UE rotation, arm swing. Throughout piece more up/down as well as sideways (rotate/weight shift) enhanced quality for more complex gait movements.