GAIT TRAINER 3 APPLICATION/OPERATION MANUAL 950-400 950-401 950-402 950-403 950-404 950-405 950-406 950-407 950-408 BIODEX Biodex Medical Systems, Inc. 20 Ramsey Road, Shirley, New York, 11967-4704, Tel: 800-224-6339 (Int’l 631-924-9000), Fax: 631-924-9338, Email: info@biodex.com, www.biodex.
GAIT TRAINER 3 This manual covers installation and operation procedures for the following products: 950-400 950-401 950-404 950-402 950-403 950-405 950-406 950-407 950-408 Treadmill, Treadmill, Treadmill, Treadmill, Treadmill, Treadmill, Treadmill, Treadmill, Treadmill, Gait Trainer Gait Trainer Gait Trainer Gait Trainer Gait Trainer Gait Trainer Gait Trainer Gait Trainer Gait Trainer 3, 3, 3, 3, 3, 3, 3, 3, 3, 115 VAC 230 VAC 100 VAC 115 VAC, with Extended Handrails 230 VAC, with Extended Handrails 10
TABLE OF CONTENTS 1. IntroductIon ..........................................................................................................................1-1 2. safety consIderatIons for General use ..............................................................2-1 3. setup ................................................................................................................................................3-1 • Connecting the Printer ..........................................................
1. INTRODUCTION Designed specifically for rehabilitation and retraining of gait for patients with neurologic and orthopedic gait dysfunctions, the Biodex Gait Trainer provides both the audio and visual feedback needed to progress patients quickly and safely to normal ambulation. The Gait Trainer is easy to use. The clinician need only select the patient’s age and height for the treadmill to automatically calculate the exact speed needed to achieve desired step cycle.
! 2. SAFETY CONSIDERATIONS FOR GENERAL USE The following safety considerations should be observed for all patients who exercise on the Biodex Gait Trainer. Additional clinical considerations, specific to gait training, are provided in the chapter titled: Clinical Applications and References. 1. 2. 3. 4. 5. All patients should consult a physician before beginning any rehabilitation program. Instruct patient on proper use and all Gait Trainer safety features before beginning exercise.
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2. CLINICAL CONSIDERATIONS FOR GENERAL USE 1 2 3 4 5 6 8 7 Figure 2.1. 1. Reset Button 2. Remote CRT Monitor Connector 3. PS 2 Connector 4. Ethernet activity lights. Green indicates connectivity. Yellow indicates activity. 5. Auxiliary Com Port (Serial Port) 6. Ethernet Connector (RJ 45) 7. PCB activity lights. Green indicates compact flash activity. Yellow indicates power on. 8. USB Connectors (suggested to use one of these for printers) Figure 2.2.
3. SET-UP Attach Printer Cable (underneath display) Attach Safety Lanyard Figure 3.1. Attaching the Safety Lanyard, printer cable and printer. Included with the Gait Trainer are a printer, printer stand and Safety Lanyard. These should all be attached/installed prior to operation of the Gait Trainer. connectInG the prInter (wired) (See Section 13 for wireless printing information) (See Figure 3.1.
CONTENTS handraIl InstallatIon (optIonal) (See Figures 3.2 – 3.4.) Figure 3.2. Figure 3.3. Figure 3.4. The Biodex Gait Trainer comes with a sturdy support bar installed (Figure 3.2). Optional Standard (Figure 3.3) and Geriatric/Pediatric handrails (Figure 3.4) are also available.
CONTENTS The Biodex Gait Trainer 3 comes with a sturdy support bar, but optional Standard Rehab and Geriatric/Pediatric handrails are also available. Both optional handrails are installed as follows: Note: Do not fully tighten any screws until all the screws and hardware have been positioned and partially secured. 1. 2. 3. 4. 5. 6. 7. 8. Using a Phillips screwdriver, remove the two screws that attach the cover plate to side of the display support bar. Set the screws and mounting plates aside.
CONTENTS situation 2: It is not required that the main power switch be turned on and off each day. The Gait Trainer display will actually go into a sleep mode when not in use. This is the “Screen Saver” function. This “Not in use time period” can be adjusted in the Configuration menu found in Utilities. In the event the main powered is cycled on and off, the Gait Trainer will automatically check the strain gages.
CONTENTS If in the unlikely event, the Gait Trainer can not bring the strain gages into the necessary ranges, the Treadmill function is unaffected and use in the treadmill mode can continue. Please contact Biodex Customer service to resolve the Gait Trainer problem.
4. GAIT TRAINING 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 Training Mode. Rehabilitation treadmill operation is described later in this manual. the GaIt traInInG Mode The Gait Training Mode is useful for the rehabilitation and retraining of gait for patients with neuralgic and orthopedic gait dysfunctions. It provides both audio and visual feedback for patient compliance.
CONTENTS the GaIt traIner user setup InforMatIon screen (See Figure 4.2) Figure 4.2. The Gait Trainer User Setup Information screen. The Opening Menu displays three icons: Gait Trainer, Treadmill and Utilities. Touch to advance to the User Setup Information screen. This screen allows entry of patient information and parameters used for gait training. At the User Setup Information screen, simply touch the appropriate icon to begin entering information.
CONTENTS • A/V Biofeedback Options: Touch to enter biofeedback options from the Audio/Visual Biofeedback Options screen. • : Go back one screen. • : Advance to the next screen. the audIo/vIsual bIofeedbacK screen (See Figure 4.3.) Figure 4.3. The Audio/Visual Biofeedback screen. The Audio/Visual Biofeedback screen (A/V) is accessed from the Gait Training User Information screen by touching the icon. At this screen, biofeedback parameters can be entered or set.
CONTENTS the footfalls/hIstoGraM screen (See Figure 4.4 – 4.5.) Toggle by pressing yellow dot to display speed as cycles/sec, MPH, or meters/sec Real time (average of last 5 steps) display of step length Y axis – Step Length can be scales 0-60 cm, 0-80 cm, 0-100 cm or 0-120 cm. X axis – can be TIME, DISTANCE or STEPS To change the axis label: Before the gait training has started simple touch the axis label to toggle between choices. Figures 4.4. and 4.5.
CONTENTS • Speed (mph): Located at the top right of the screen. Use the associated ▲ and ▼ icons to set this goal to match the desired cycles per second. Walking speed is displayed in MPH or KMH. The default value will be according to how the Gait Trainer is set up (English or Metric). Most people can relate better to MPH or KMH, than cycles per second. If you want to know what the cycles/second are, toggle the speed on the left.
5. NORMATIVE DATA (Refer to Tables A1 and A2.) The normative data charts provided in this manual can be used to develop rehabilitation programs and discharge criteria for your patients. The normative values are based on age and gender so comparisons can be easily made. Note: Clarification of Normative Data for the Gait Trainer: The normative data presented in the Biodex Gait Trainer 3 id derived from the reference tables in Gait Analysis, An Introduction, 2nd. Edition, Michael W. Whittle, 1997, pgs.
6. GAIT TRAINER OPERATION GaIt traIner theory of operatIon 1. Walking (gait) speed can be increased two ways: Increase step frequency (step cycle) or increase step length. 2. Step cycle: A successive heel strike for the same foot, i.e. Right step, left step, right step. Set belt speed based on how many complete successive heel strikes occur within a second. .1 cycle per second is very slow, 3 cycles per second is fast. Normal walking step cycle approximates 1 cycle per second. 3.
7. EXERCISE RESULTS (See Figures 7.1, 7.2 and 7.3.) Exercise results can be reviewed from the Exercise Results screen only after touching to end the exercise session and then touching . Figure 7.1. The Exercise Results screen. Note the Exercise Results functions available at the bottom of the screen. exercIse results paraMeters Time: This displays the total elapsed time from the start of the exercise until either the end of the exercise bout or when the button is pushed.
CONTENTS RT/LT time distribution: This is the actual time spent on the mentioned limb. The time spent on each limb should be equally distributed between right and left. Should they be different, the patient is spending more time on one leg than the other. Ambulation Index: This is a composite score relative to 100 based on foot-to-foot time distribution ratio and average step cycle. The goal is 100.
CONTENTS Figures 7.2 and 7.3: Gait Trainer printouts include a Biodex Gait Training Exercise Summary and Biodex Gait Training Exercise Histogram.
CONTENTS Gait trainer progress report A progress report is perfect for showing need, progress and outcome. Progress reports for specific parameters are available when a patient has multiple exercise reports. Select any of the patient records by touching the yellow dot.
CONTENTS Touch the parameter that you are interested in viewing and/or printing progress. Green indicates selected. Also, choose to have data points on the report and/or Normative data ranges. Total time same for each exercise session.
CONTENTS Average walking speed increased over two months. As the steps increased so did the distance over two months.
CONTENTS Step length became symmetrical and normal after two months. Step length variability decreased as the steps became symmetrical and approached normal after two months.
CONTENTS Equal time was spent on each foot after two months.
8. TREADMILL OPERATION Figure 8.1. The Quick Start feature allows the user to begin the exercise session with minimal input. QuIcK start operatIon (See Figure 8.1.) 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. Quick-Start operation is simple. With the system turned ON, position the user on the treadbelt and proceed as follows: 1.
CONTENTS QuIcK start tracK / nuMerIc dIsplay paraMeters Users can choose from a Quick Start Exercise Track or Numeric display during Quick Start exercise sessions. The following parameters are displayed for both choices. Note: To toggle between displayed parameters (i.e., to change measurement units for calories, pace or distance) touch the yellow dot next to each parameter heading. Time: Cumulative time in minutes/seconds from the point at which the treadbelt begins to move in either direction.
5. MANUAL OPERATION Figure 8.2. The RTM 600 Setup Options screen allows entry of patient-specific information and parameters. Manual treadMIll operatIon (See Figure 8.2.) Manual treadmill operation is easy. Like the Quick Start function, Manual Start allows the user to begin exercising quickly. Rather than use default settings, however, this mode of operation prompts the clinician to enter the patient’s body weight, select the treadbelt direction, and enter values for Time, Distance and Calories.
CONTENTS 5. When all parameters are entered/selected, press on the display to activate the treadbelt and begin the exercise session. The treadbelt will ramp up to .1 mph. 6. Use the <▲> and <▼> arrows on the Exercise Track or Numeric Display to adjust the speed setting to the desired value. Both speed and elevation can be adjusted at any time during the exercise session. 7. Touch to pause the exercise session at any time. Press to resume the exercise session. 8.
CONTENTS Figure 8.3. The Exercise Track display. Figure 8.4. The Numeric display.
9. 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. Users can select any of the pre-defined exercise profiles, review or edit any exercise profile, or delete an existing exercise profile.
CONTENTS Figure 9.1. The Select Profile screen allows the user to choose from five pre-defined profiles. Figure 9.2. At the Profile Setup Options screen, users can enter values for time, body weight and maximum elevation.
CONTENTS Figure 9.3. Ready to begin an exercise session with Profile 1, Anaerobic, selected. desIGnInG a custoM exercIse profIle (See Figure 9.4.) To design a custom exercise profile: 1. At the treadmill Opening Menu touch . The Select Profile Menu should now be displayed 2. Touch option six, . The Custom Profiles screen should now be displayed. 3. Touch and then enter the number (1 – 12) of the profile you would like to design. Touch .
CONTENTS Figure 9.4. At the Editing Profile screen, clinicians enter values for speed, elevation and time for each of up to ten stages for any profile.
10. GAIT TRAINER UTILITIES Figure 10.1. The Utilities Menu allows access to the Configuration and Patient Management screens. The System Maintenance screen, not displayed, is also accessed through the Utilities Menu. The Utilities Menu allows users to access the Configuration, Patient Management and System Maintenance (not shown) screens. The Utilities Menu also displays technical information about the Gait Trainer, firmware version, and cumulative hours of use.
CONTENTS confIGuratIon (See Figures 10.2 and 10.3.) Figure 10.2. The Configuration screen. To advance to the Configuration screen from the Utilities Menu, touch . Enter 781 at the “Access ID Code” prompt and touch . The Configuration screen should now be displayed. This screen allows the user to choose between various display options and to set specific parameters for a variety of treadmill functions. Following is a description of Configuration screen options.
CONTENTS Set Date/Time: Touch to change the system time or date. Touch to highlight the value to change, then use the <▲>or <▲> icons to increase or decrease the value as desired. Touch to return continue and return to the Configuration screen. LCD Brightness: Touch any section of the horizontal bar to select a new brightness setting. Selecting low numbers along the bar will result in a darker screen while selecting high numbers makes the screen appear brighter.
CONTENTS patIent ManaGeMent (See Figures 10.4 and 10.5.) Figure 10.3. The Patient Management screen. Figure 10.4. The Stored Patient Exercise screen. To advance to the Patient Management screen from the Utilities Menu, touch . Enter 781 at the “Access ID Code” prompt and touch . The Patient Management screen should now be displayed.
CONTENTS Patient Management functions include the ability to delete an individual patient file, multiple patient files, print a stored exercise report, print a stored patient histogram and export patient data. A description of each feature follows. deleting patient files To Delete An Entire Page of Patient Files: 1. Touch the icon. The system will ask if you are sure you want to delete the selected files. Touch .
CONTENTS systeM MaIntenance The System Maintenance screen is hidden from normal view. This screen, when active, allows the user to select the treadmill type (Gait Trainer or RTM600), perform speed and elevation calibration, and perform strain gauge calibration. To access the System Maintenance screen: 1. Touch . Note: The next step requires pressing the hidden keypads in the upper right and left corners of the displays touch screen. 2. 3.
11. MAINTENANCE Your Biodex Gait Trainer 3 should provide trouble-free operation as long as the following maintenance procedures are performed. To verify hours of operation, simply touch button (see Figure 11.1). At the bottom of screen, hours of use will be indicated (see Figure 11.2). Be sure to adhere to the hours of usage guidelines in Figure 8.3. Be sure to adhere to the hours of usage guidelines in the chart below.
CONTENTS Figure 11.2. Utilities Screen, depicting hours of use. Instruction hours of usage Lubricate Deck Reverse Deck Belt Replacement Clean Motor and Amp Front Roller Cleaning 75 1,000 1,000 750 375 Figure 11.3. Hours of Usage Guidelines daIly MaIntenance As required, clean all exterior surfaces, upholstery and restraining straps. Specialized vinyl cleaners or protectants are recommended for upholstery and cushions. Otherwise, use a solution of warm water and mild detergent.
CONTENTS annually or every 1,000 hours reverse exact-track bed Reverse the Exact-Track bed. The Gait Trainer 3 bed is double-sided, allowing it to be reversed and used over. Once both sides have been used, the bed must be replaced. replace treadbelt Inspect Treadbelt for cracks or tears. If none are found, continue to use. If any cracks or tears are apparent, replace treadbelt. MaIntenance procedures belt/deck lubrication (See Figure 11.4.) 1. 2. 3.
CONTENTS treadbelt adjustment 1. Remove the 6 Phillips head screws from the cover. Lift the cover off the treadmill. (See Figure 11.5) Figure 11.5. Treadmill Cover 2. Touch Treadmill icon on main screen and adjust the speed to 1.0 mph. (See Figure 11.6) Figure 11.6.
CONTENTS 3. Walk on the treadmill at 1.0 mph and stop the treadbelt with your foot. Front roller should slip under the treadbelt. (See Figure 11.7 and 11.8) Figure 11.7. Treadmill shown without cover. Note the location of front roller. Front roller Figure 11.8. Close up of motor, showing front roller.
CONTENTS 4. Adjust the two belt tensioning bolts evenly at the back of the treadmill so that the front roller slows down but continues to turn when you stop the treadbelt with your foot. (See Figure 11.9) Figure 11.9. Back of Treadmill shown for tensioning bolt location. treadbelt alignment Adjust the two hex bolts so that the distance between the end of the roller and the edges of the belt are equal on both sides. (See Figure 11.
12. TROUBLESHOOTING syMptoM Gait Trainer 3 is turned ON and speed control is inoperable (belt not moving). Check for faults on display. The following diagnostic error codes apply: CODE DESCRIPTION 128 Communication between upper/lower board inop 64 Safety Lanyard Removed 32 Control fault (no amplifier) 16 Grade Error 8 Motor Tach Output Exceeds Selected Speed 4 Motor Tach Output is Below Selected Speed Note: The above faults indicate an issue with your treadmill.
13. ELECTROMAGNETIC COMPATABILITY conformance to standards This equipment conforms to the following safety standards: standard edition and/or date IEC60601-1-2 First edition, 2007 Table 1.1 Safety standards accompanying eMc documents This medical electrical equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in this manual. • Portable and mobile RF communications equipment can affect medical electrical equipment.
CONTENTS declaration of conformity emissions Manufacturer’s declaration electromagnetic emissions The Gait Trainer 3 Treadmill is intended for use in the electromagnetic environment specified below. The customer or the user of the Gait Trainer 3 Treadmill should assure that it is used in such an environment emission test compliance electromagnetic environment RF emissions CISPR 11 Group 1 The Gait Trainer 3 Treadmill generates RF energy only for its internal functions.
CONTENTS Continued from previous page Immunity test Iec 60601-1-2 test level Iec 60601-1-2 compliance level electromagnetic environment – guidance Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11 < 5% UT (> 95% of dip in UT for 1/2 cycle) 40% UT (60% of dip in UT) for 5 cycle 70% UT (30% of dip in UT) for 25 cycle < 5% UT (> 95% of dip in UT) for 5 sec < 5% UT (> 95% of dip in UT) for 1/2 cycle 40% UT (60% of dip in UT) for 5 cycle 70% UT (30% of dip
CONTENTS recommended separation distances Recommended separation distances between portable and mobile RF communications equipment and the Gait trainer 3 treadmill. table 6 The Gait Trainer 3 Treadmill is intended for use in the electromagnetic environment in which radiated RF disturbance are controlled.
14. SPECIFICATIONS Dimensions: 86" l x 27" w (218 x 69 cm) Walking Area: 64" l x 20" w (160 x 51 cm) Printer Stand: 24" l x 24" w (61 x 61 cm) Motor: 2 HP with 4Q-Pulse Width Modulation Control Speed Range: Forward: 0-10 mph (0-16.9 km/h) Reverse: 0-3 mph (0-4.8 km/h) in 0.1 mph (.16 km/h) increments Elevation: 0-15% Grade Heart Rate Monitoring: Polar® Telemetry (Chest Strap) and contact handgrip Deck: 1" thick (2.
15. REFERENCES AND BIBLOGRAPHY references: 1. Burchfeild, JB. Reading the Body’s Gas Guage. Advance for Providers of Post-Acute Care: April, 1999, pp: 57-72. 2. Whittle, MW. Gait Analysis: An Introduction. Butterworth - Heinemann, Second Edition, 1997. 3. Sekiya, N., et al. Optimal Walking in Terms of Variablity in Step Length. JOSPT, Vol 26 (5): 266272, Nov. 1997. bIblIoGraphy: BARBEAU, H, et al.
CONTENTS GOLDIE, PA, et al. DEFICT AND CHANGE IN GAIT VELOCITY DURING REHABILITATION AFTER STROKE Arch Phys Med Rehabil, Vol. 77:1074-1082 / Oct 1996 Biodex #91-142 PREDICTION OF GAIT VELOCITY IN AMBULATORY STROKE PATIENTS DURING REHABILITATION Arch Phys Med Rehabil, Vol. 80:415-420 / April 1999 Biodex #92-215 HESSE, S, et al.
CONTENTS MULCARE, JA, et al. PHYSIOLOGICAL RESPONSES DURING UNWEIGHTED AMBULATION: A PILOT STUDY Abstract PT – 78(5) / May 1988 Biodex #91-126 NADEAU, S, et al. ANALYSIS OF THE CLINICAL FACTORS DETERMINING NATURAL AND MAXIMAL GAIT SPEEDS IN ADULTS WITH A STROKE Am J of Phys Med & Rehabil, Vol. 78(2): 123-130 / March-April 1999 Biodex #91-154 NELSON, AJ DO WE NEED QUANTIFIED GAIT ANALYSIS IN THE CLINIC?….
CONTENTS SHARP, SA, et al. ISOKINETIC STRENGTH TRAINING OF THE HEMIPARETIC KNEE: EFFECTS ON FUNCTION AND SPASTICITY Arch Phys Med Rehabil, Vol 78 / Nov 1997 Biodex #91-148 STAMER, MH TREATING GAIT DYSFUNCTION IN KIDS WITH CP Advance for Directors in Rehabilitaton: 59-62 / June 1997 Biodex #91-133 SUZUKI, K, et al.
CONTENTS WOLFF, M, et al. BEYOND STRIDE – OTHER CONSIDERATIONS WHEN DECIPHERING GAIT OF PEOPLE WITH AMPUTATION Advance for Physical Therapists: 28-32 / March 9, 1998 Biodex #91-140 Rev.
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Certified Quality Management System BIODEX Biodex Medical Systems, Inc. 20 Ramsey Road, Shirley, New York, 11967-4704, Tel: 800-224-6339 (Int’l 631-924-9000), Fax: 631-924-9338, Email: info@biodex.com, www.biodex.
