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BALANCE SYSTEM SD - Biodex Medical Systems

1. 2 Position the printer on the printer stand as shown 3 Locate the black printer power cable Plug the small end into the power receptacle on the back of the printer Do not connect any other equipment to this receptacle 4 Plug the AC plug end of the power cable into power cable port on the back lower base of the Balance System 5 Locate the white USB cable Connect one end of the cable to the USB port on back of the Balance System display Connect the other end of the cable to the USB port at the back of the printer directly above the power cable port 6 Ensure both cables are positioned so that they will not interfere with the patient or get caught in the Balance System platform or handles 7 Insert several sheets of paper into the printer paper holder Insert the paper holder into the top of the printer so that the open end interlocks with the printer and the paper faces out toward you 8 With power ON to the Balance System press the Power ON switch on the printer Ensure the printer s green Ready LED comes on to indicate the printer is receiving power Refer to the supplied printer manual for additional printer information e ASSEMBLY amp INSTALLATION Figure 3 1 The printer power cable should be plugged into the AC receptacle on the rear base of the display support post The printer USB cable should be plugged into the USB port on back of the display 1 Reset Button 2 Remote CRT Monitor Connector 3 PS
2. 4 20x 75 LG 4 RER DOO ITE BLUE REF CONTROL MODULE ASS 1850 300 A030 J 950 300 W205 WELDMENT II INT WIG PLATE 1 REID 8 IB SOLIER PADS LOCATION A 12905 J JIINTC 1 77 Quy SPUR ANOUFF 4 19 Lo 2 VD W Wh W W x 50 LG 2 RER D TOP NNTG 2 RER D CAD HD 6 32x 2510 6 FLAT 1 RER D IES 3 RER D Y i fia tcs END D ROLLER CHAIN 25 S 1 RER D 08277 BRG THRUST 3 810x 7300x 06THK 3 12936 WASHER 11730 REF JOLINFx 18 6 6 REGU 950 300 1316 PLATE LUCK 8 R 08378 GREASE OPEN GEAR A R 09134 SCR SHOULDER 1 40 09405 NUT HEX ELEASTIC BRG 3 RER D PIND GREEN VR 3 8 16 950 300 4130 U JOINT MOTUR 4 WELOMENT 1 REND gt RER I TTE BLUE REF 850 300 4335 PLATE SPRING C12 REID CR HEX HD 3 8 16x 75 LG E 85 op IBI JILT TYP SEW AS REQ D amp FRAME SUPPORT REQ 0 A BEARING IBE GR 045 300 M317 SPRING PLATE ACME N 950 300 334 TUBE GUIDE 12 REG D 960 LOCTITE 638 RETAINING CLMPULND AR B4 NITE CLEAN SURFACES WITH ALCOHOL PRIOR 10 APPLYING LDCTITE SUPPORT 3 REN D 08621 BOST BRONZE PLAIN ING 3 SED PRESS BRG IN SO IT IS FLUSH WITH BOTTOM Jo0 MOTOR AND BRKT ASSY 1 RED
3. lt p SGB Firmware 1 10 Hours Of Use 1 Back Next Patient Data Storage Usage Meter Patient Data Storage Usage is scaled to 6 000 patient tests When storage reaches 85 of its capacity it is suggested that patient tests be deleted or archived You may archive patient data to a USB memory device or to a computer or network using the Biodex Patient Data Collection Software Ee SYSTEM UTILITIES CONFIGURATION See Figure 11 1 At the System Utilities screen touch Configuration and then enter 781 in response to the Enter Access Code prompt Touch lt OK gt The Configuration screen should now be displayed At this screen users can set values for Screen Time Out Screen Saver Date Time Fall Risk Defaults m CTSIB Defaults and Change Access ID Code You can also turn Tone ON OFF adjust LCD brightness or Tone volume and select Measurement Units Printer Resolution or Joystick Emulation When you have finished making all of your selections and adjustments touch lt OK to return to the Main Menu Configuration Set Screen TimeOut Fall Risk Defaults Screen Saver m CTSIB Defaults Set Date Time Change Access Id Code Measure Units U S Tone Printer Resolution Normal Tone Volume gt e Joystick Emulation Disabled 6 Secure Code Access Disabled Back Figure 11 1 The Configuration screen SET SCREEN TIME OUT The Screen Time Out setting determines how long the display screen remains ON when the
4. quipement sans l autorisation du fabricant A CAUTION If this equipment is modified appropriate inspection and testing must be conducted to ensure continued safe use of equipment N ATTENTION Si cet quipement est inspection modifi e appropri e et essais doivent tre effectu s pour s assurer a continu l utilisation s curitaire de l quipement For disposal information at the product s end of life contact Biodex For additional technical advice service or education information please contact Biodex Medical Systems Inc 20 Ramsey Road Shirley New York 11967 4704 1 800 224 6339 Int l 631 924 9000 or customerservice biodex com V BEFORE PROCEEDING PRODUCT CERTIFICATIONS AND CLASSIFICATIONS The Balance System SD has received the following certifications and falls within the following classifications ETL Listed Electrical Equipment Laboratory Use Part 1 General Requirements for Safety conforms to UL 60601 1 CAN CSA C22 2 No 601 1 M90 IEC 60601 1 IEC 60601 1 4 and IEC 60601 1 2 and CE Marked FDA Class II Equipment EC Certificate EC 4132458 NOTE Circuit diagrams for this product are provided in the Schematics section at the back of this manual Authorized European Community Representative ee e Emergo Europe Molenstraat 15 2513 BH The Hague The Netherlands Type B Applied Part A CC Electromagnetic Compatibility This equipment complies with the Medical Equip
5. setups and positioning with a healthy subject before attempting to set up an injured patient e To assist our users and stimulate interest in developing protocols this manual contains a Clinical Considerations section where appropriate These comments come from the clini cal experience of our users as well as from published journals e The product is intended to remain in one location during operation The product is provid ed with wheels for relocation and should be used when performing this operation It is rec ommended that two persons move the product A CAUTION It is recommended that patients wear non skid foot wear when using this device ATTENTION Il est recommand que les patients portent des pieds antid rapants usure lors de l utilisation de ce dispositif NOTE Service should be provided by qualified personnel only Please do not attempt installation or repair on your own Call Biodex Customer Service first they ll be glad to help CAUTION Modifications to this product are not allowed Unauthorized modification of the prod Z uct can result in hazards to the operator and patient and will void the manufacturer s warranty Do not modify this equipment without authorization from the manufacturer N ATTENTION Des Modifications ce produit ne sont pas autoris es Modification non autoris e du produit peut entrainer des risques pour l op rateur et le patient et annulera la garantie du fabri cant Ne modifiez pas cet
6. should be that of a typical commercial or hospital environment APPENDIX E 2 Continued from previous page Immunity test IEC 60601 1 2 IEC 60601 1 2 Test level Compliance level Voltage dips short lt 5 UT gt 95 of dip lt 5 UT gt 95 of dip interruptions and in UT for 1 2 cycle in UT for 1 2 cycle voltage variations 40 UT 60 of dip 40 UT 60 of dip on power supply in UT for 5 cycle in UT for 5 cycle input lines 70 UT 30 of dip 70 UT 30 of dip IEC 61000 4 11 in UT for 25 cycle in UT for 25 cycle lt 5 UT gt 95 of dip lt 5 UT gt 95 of dip in UT for 5 sec in UT for 5 sec Power frequency 3 A m 3 A m 50 60 Hz magnetic field IEC 61000 4 8 Conducted RF 3 Vrms 3 Vrms IEC 61000 4 6 150 KHz to 80 MHz 150KHz to 80 MHz Radiated RF 3V m 3V m IEC 61000 4 3 80 MHz to2 5 GHz 80 MHz to2 5 GHz NOTE 1 UT is the a c mains voltage prior to application of the test level NOTE 2 At 80 MHz and 800 MHz the higher frequency range applies NOTE 3 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflections from structures objects and people Field strength from mixed transmitters such as base stations for radio telephones and land mobile radios amateur radio AM or FM broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmi
7. strategies or synergies to simplify movement The central nervous system CNS takes advan tage of pathways that link together groups of muscles in a flexible and repeatable sequence This linking or packaging of muscle groups allows the brain to respond to an infinite variety of cir cumstances by drawing on muscle responses that have been successful in the past This linking or packaging of muscles in a repeatable sequence is called a movement strategy Utilizing a movement strategy simplifies the way the nervous system accesses a motor reaction in response to sensory input Strategies are automatic reactions that have evolved over time tak ing into account biomechanical and environmental constraints Strategies that are successful for maintaining balance are stored so that the CNS is not forced to start from scratch each time a loss of balance occurs Strategies are automatic reactions slower than reflexes but much faster than voluntary movements Three anterior posterior movement strategies have been identified the ankle hip and stepping strategies Ankle Strategy The nervous system employs the ankle strategy in response to small losses of balance and to adjust balance in quiet standing The ankle strategy is also called ankle sway and uses the length of the foot as a lever to correct for minor losses of balance In the ankle strategy activation of the leg muscles is from the floor up or distal to proximal A small loss of balance in the forw
8. system is no longer in use following a test exercise Once the selected time expires the system returns to the Main Menu 1 At the Configuration Screen touch Set Screen Time Out The Set Test Exercise Complete Screen Time Out screen should now be displayed 2 Use the lt A gt or W gt arrows to increase or decrease the value displayed in 00 30 second increments The Time Out range is from 00 00 to 30 00 3 Touch lt OK to confirm your changes and return to the Configuration screen Touch Cancel to return to the Configuration screen without making any changes SYSTEM UTILITIES Eque SCREEN SAVER The Screen Saver setting determines how long the display screen remains ON when the system is no longer in use Once the selected time expires the screen fades to black even if the system remains ON 1 At the Configuration Screen touch Screen Saver gt 2 Use the lt A gt or lt W gt arrows to increase or decrease the value displayed in 1 minute increments The Time Out range is from 00 00 to 60 00 3 Touch lt OK gt to confirm your changes and return to the Configuration screen Touch Cancel to return to the Configuration screen without making any changes SET DATE TIME Time and Date are system wide parameters that show on all printed reports 1 Atthe Configuration Screen touch Set Date Time The Set System Date Time screen should now be displayed 2 Touch the parameter to set so that the
9. 4 of samples M L Mean Deflection Xn n th sample Standard Deviation The amount of variability in the statistical measure A low standard devia tion demonstrates that the range of values from which the mean was calculated were close together Y 4 Xn X n of samples Standard Deviation Dn _______ Xn n th sample n pa X mean deflection NOTE Mean A P and M L Deflections are from the patient s actual position in contrast to the Stability Index which is a variance from level as established during the centering patient portion of the test proto col The resulting scores for Mean A P and M L Deflections are not statistically effected by the centering process REPORTS 9 2 Percent Time In Zone Quadrant These values represent the percentage of test time the patient spends in each Zone Quadrant during the test The Target Zones A B C and D are equal to specific ranges of deflection and radiate in con centric circles from the center of the foot platform as follows Zone A zero to five degrees foot platform deflection from level Zone B six to ten degrees foot platform deflection from level Zone C 11 15 degrees foot platform deflection from level Zone D 16 20 degrees foot platform deflection from level Quadrants represent the four quarters of the Test Grid in the X and Y axis as follows For the Both Feet protocol e Quadrant 1 right anterior e Quadrant 2 left anterior Quadrants re
10. 72 Sample Size N 50 N 52 N 50 N 17 OSI Average 1 4 1 9 2 3 3 0 OSI SD 0 7 12 14 1 0 There was a significant mean difference for balance scores between 1 Age group 1 and Age group 3 2 Age group 1 and Age group 4 and 3 Age group 2 and Age group 4 That is the youngest subjects were more stable than the third oldest subjects The youngest subjects were more stable than the oldest subjects And the second youngest subjects were more stable than the oldest subjects Also the two youngest groups were similar in their balance stability and the two older groups were similar in their balance stability B APPENDIX B APPENDIX C CTSIB NORMATIVE DATA COLLECTION AND RELIABILITY CTSIB reliability and predictive score data were collected from 100 randomly recruited people All test subjects were healthy active working people Medical history was recorded via a confi dential questionnaire The testing and protocol followed IRB approval and was performed on site In addition to the CTSIB all 100 recruits participated in a Timed Get up and Go TUG and Gait Speed assessment The TUG and Gait Speed tests are accepted tests for Balance assessment The reason for doing the additional tests with the CTSIB was to strengthen the results when a posi tive correlation is made between the three accepted standardized assessments Subjects were tested initially then again 2 weeks later A third follow test was administe
11. 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 com
12. D REPLACEMENT R 4 R 5 REPLACEMENT 950 440 4020 ADJ DISPLAYS TUBE ASSY 1 RET O DISPLAY FRAM 2 USPLYFRMASSYBEO 40 1010 A 70 m4 EI 950 440 357 PLATE g nw CD 950 300 430 08893 CILLAR CLAMP LUN 1 25 DIA 1 RED TN 1 ACER 1 RED D CR L08921 ERG NYLINER J 125 DIA 2 RETO SL 950 440 0140 Li CO WIEN HANDLE BAR 1 RED 10 345 300 4330 HAND CS DIR PULL PIN LO oad SPRIN COMPRESSION 1 REDD 7 1730 SUPER LLBI d ASE A R 9 08989 GRIP EDAM 12 ID x4 LG 13315 HOLE PLUG 21 i DIA 250 MTG HOLE 2310367 RETAINING CLANP 1 RER D 94 23 DIA 1 REDD i 7 08004 NUT HEX HD 930 440 W100 1 16 32 2RER D WELOMENT BAS E AN 1 RER D 09406 SCR PH IL PNGA M 6 32LNCx 50LG C13012 NUT CLIP C2 H0 32 7 R B 4 2 n 09013 WASHER FENDER RER D REPLACEMENT R 097 056 STHL JSN d 1 UJ7 50 Ova 29 FR DEN E2800 d CD 8 Tf I 081 005 56 AND OQLV 0 Lo SIH ES CE NLINI UD 1 30 ld 108 097 0656 33S DN REPLACEMENT p 19197 SCR SUC FLAT HD 1
13. Eyes Open Firm Surface 0 89 Better 0 50 Worse Baseline Normals very stable Eyes Closed Firm Surface 1 39 Better 1 00 Worse Somatosensory is predominant Vestibular is secondary imi Normals have similar scores to eyes open firm A Eyes Open Foam Surface 1 73 Better 0 75 Worse Vision is predominant Vestibular is secondary Normals sway more on foam than firm but remain stable A Eyes Closed Foam Surface 2 17 Better 2 25 Worse Vestibular is predominant 2o HENEEE TI Normals sway more with eyes closed on foam than A with eyes open on foam but remain stable o ooo Back Save Results Home The CTSIB presents results in a manner that is easy to understand and communicate T A description of the relationship of the test condition to the sensory system is provided when the m CTSIB protocol format of 4 conditions is used Space limitations preclude the descrip tion for 6 conditions The 4 condition m CTSIB test is the preferred test protocol anyway The results are presented relative to the upper limit of the normal reference data Patient results will either be better equal to or worse than normal The higher the Sway Index score the more unstable the patient was for the condition Total instability where they had to hold onto something or stop is considered a Fall and is noted as Fell in the test results The number at the midpoint of the scale is the upper limit of the normal score rounded to the nearest 25 For example a E
14. Fall Risk Test Results Actual STD Score Dev Overall Stability Index 2 4 0 39 Your score compared to age group of healthy people GE A ENT HE ETE E EE S E A E ES E ELE EE EE APT E DRE N 72 89 YRS HERE Ep pop pos bs oops n 54 71 YRS i 0 0 9 5 1 0 4 5 2 0 2 5 3 0 3 5 4 0 45 5 0 Your Score A 72 89 yrs ll 54 71 yrs W 36 53 yrs IN 17 35 yrs Back Print Save Results Home Figure 8 14 A sample Fall Risk Test Results screen PERFORMING A FALL RISK TEST See Figures 8 13 and 8 15 1 Position support handles as per patient protocol 2 Position display height and tilt for patient comfort 3 Atthe Main Menu touch Testing The Testing Menu screen should now be displayed 4 Touch Fall Risk The User Setup Information screen should now be displayed 5 Touch the Keypad icon for Name and enter the patient s name Touch lt OK gt to return to the User Setup Information screen 6 Touch the lt Keypad gt icon for Age and then enter the patient s age Touch lt OK to return to the User Setup Information screen 7 Touch the appropriate lt Height gt key to highlight the patient height range setting desired Touch lt Next gt to advance to the Patient Position screen 8 Position the patient on the system and explain the test protocol Press Start on the display to activate the cursor and have the patient move the cursor to the center
15. Heel Position D6 D16 Test Trial Time 20 secs Age 47 Test Trials 1 Cursor ON Condition Sway Index Mean v Eyes Open Firm Surfaco os CN rir mb Baseline Normals very stable 0 35 v Somatosensory predominant Vestibular secondary Normals sway more with eyes closed 0 73 y Vision predominant Vestibular secondary Normals sway more on foam than firm 0 54 v Vestibular predominant Normals sway most with eyes closed on foam 1 65 n wee m wl L M Posterior Posterior Eyes Open Firm Surface Eyes Closed Firm Surface Anterior n gt m is asl Posterior Posterior Eyes Open Foam Surface Eyes Closed Foam Surface Comments Clinician 9 7 CTSIB Report Utilizing the CTSIB capabilities clinicians can test patients and compare results to normative data REPORTS 9 10 PROGRESS REPORTS Progress Reports graph overall stability scores for each test date selected The tests are selected from Patient Maintenance on the Utilities Menu The patient selected must have multiple tests with resultant Stability Index scores for either Postural Stability Fall Risk or Athletic Single Leg test formats Progress Report Date Range Patient Name 01 18 2008 To 01 13 2008 Session Joe Biodex Postural Stability 5 83 T sos Mh AMA Overall de FENS Stability TL Index 0148 0148 01 48 01 18 01 18 01 18 0148 Date amp 2 Back Print Figure 9 8 A Postural Stability Progress Report To Print A Progress Rep
16. J Phys Rehabil Med 2010 Vol 46 No 1 59 67 Biodex 92 291 CAMPBELL MH et al THE CORRELATION BETWEEN ISOKINETIC STRENGTH MEASURES AND FUNCTIONAL PERFORMANCE IN AN ELDERLY POPULATION Biodex 93 293 CAVANAUGH JT et al BALANCE AND POSTOPERATIVE LOWER EXTREMITY JOINT RECONSTRUCTION Orthopaedic Phys Therapy Clinics of No America Vol 11 1 75 99 March 2002 Biodex 92 244 APPENDIX G G 2 CHO KH et al EFFECT OF LOWER LIMB STRENGTH ON FALLS AND BALANCE OF THE ELDERLY Ann Rehabil Med 2012 36 386 393 Biodex 92 311 CLARK S et al GENERALIZABILITY OF THE LIMITS OF STABILITY TEST IN THE EVALUATION OF DYNAMIC BALANCE AMONG OLDER ADULTS Arch Phys Med Rehabil Vol 78 1078 1084 October 1997 92 269 DiCOSTANZA K et al EFFECT OF ADHESIVE MEDIAL LONGITUDINAL ARCH SUPPORT ON POSTURAL SWAY J of Athletic Training Vol 36 2 supp S66 April June 2001 Biodex 92 227 DOVER G et al RELIABILITY OF INVERSION AND EVERSION PEAK TORQUE MEASUREMENTS FROM THE BIODEX SYSTEM 3 ISOKINETIC DYNAMOMETER J of Athletic Training Vol 35 2 supp S 91 April June 2000 Biodex 91 185 FERRIS CM et al A COMPARISON OF STRENGTH PROPRIOCEPTION LAXITY FLEXIBILITY AND BALANCE BETWEEN BASKETBALL AND NON BASKETBALL COLLEGIATE FEMALE ATHLETES J of Athletic Training Vol 35 No 2 supp S38 April June 2000 Biodex 91 189 FINN JA et al STABILITY PERFORMANCE ASSESSMENT AMONG SUBJECTS OF DISPARATE
17. Results screen touch Home 8 9 TESTING ATHLETE SINGLE LEG STABILITY TESTING The test protocol for the Athlete Single Leg Stability Testing allows clinicians to test athletes against data derived from studies using the Biodex Balance System The low stability level of four will challenge athletes and provide the data necessary to assess the athlete s single leg pos tural stability Athletic Single Leg Stability Testing Leg Tested Test Trial Time Right O 00 20 Trials e Score DET 0 0 Platform Setting 4 Clear Tracing Press START to Release Platform D lt gt Back Home C Figure 8 9 The Athlete Single Leg Stability Testing screen Athletic Single Leg Stability Testing Options Number of Trials Rest Countdown Initial Platform Ending Platform Setting Setting CO rs Cursor a Cancel oK o Figure 8 10 The Athlete Single Leg Stability Testing Options screen TESTING 8 10 Athletic Single Leg Stability Test Results Actual STD Normal STD Score Dev Score Dev Overall Stability Index 3 0 0 83 3 9 1 9 Anterior Posterior Index 1 3 85 3 7 1 8 Medial Lateral Index 2 5 96 15 8 HHHH LLL 0 0 0 5 1 0 1 5 2 0 2 5 3 0 4 0 5 0 5 5 6 0 Your Score Overall Stability Index Jj Anterior Posterior Index DM Medial Lateral Index Another Test B Rk Same Patient Back Print Save Results Home Figure 8 11 A sample Athlete Single Leg Stabi
18. Stability Testing Options screen 8 7 TESTING Limits of Stability Test Results Time to Complete Test 00 29 Direction Control Actual Goal Overall 84 65 Forward _ 64 65 Backward 95 30 Right 96 65 Lert 99 65 Forward Right 98 65 Forward Left 93 65 BackwardRight 91 65 Backward Left 99 65 o e200 Back Save Results Home Figure 8 8 The Limits of Stability Test Results screen for a bilateral test PERFORMNIG A LIMITS OF STABILITY TEST See Figures 8 7 and 8 9 1 2 10 11 Position support handles as per patient protocol Position display height and tilt for patient comfort At the Main Menu touch lt Testing gt The Testing Menu screen should now be displayed Touch lt Limits of Stability gt The User Setup Information screen should now be displayed Touch the lt Keypad gt icon for Name and enter the patient s name Touch lt OK gt to return to the User Setup Information screen Touch the lt Keypad gt icon for Age and then enter the patient s age Touch lt OK gt to return to the User Setup Information screen Touch the appropriate lt Height gt key to highlight the patient height range setting desired Touch lt Next gt to advance to the Patient Position screen Position the patient on the system and explain the test protocol Press lt Start gt on the display to activate the cursor and have the patient move the cursor to the center point on the gri
19. Touch Skill Level to tighten or widen the spread between targets Three skill levels are available from which to choose Touch lt Skill Level gt until the desired target configuration is displayed If desired touch lt Clear Tracing gt to remove any tracing that remains on the screen from a previous exercise session Touch lt More Options gt to advance to the Limits of Stability Training Options screen if desired Here you can set the Limits of Stability Hold Time for the exercise and turn Tracing ON OFF Touch lt OK gt to confirm your selections and return to the Limits of Stability screen or lt Cancel gt to return to the Limits of Stability screen without making changes e To set a Limits of Stability Hold Time use the lt A gt or lt W gt keys to scroll to the desired setting Hold times range from 025 to 5 seconds e To turn tracing ON OFF touch lt Tracing gt to toggle between choices At the Limits of Stability Training screen touch the lt A gt or lt W gt keys to select the desired platform stability static 12 is most stable 1 is least stable Explain the training protocol to the patient then press lt Start gt to begin the LOS training ses sion The LOS Training screen reflects the patient s stability performance through the course of the LOS training session The Elapsed Time from the start of the training session is shown at the top right of the display while the stability level is illustrated by a bar g
20. can be stopped at anytime to proceed to the test rep m CTSIB Testing Q Tracing Clear Tracing Eyes Open Firm Surface Test Trial Time 00 30 Trials 1 Sway Index Condition 1 4 Press COLLECT DATA to Begin Test Collect Data Practice Trial Back After completing the condition the next test condition will follow until all conditions have been completed When the last condition is completed a Test Complete message is displayed Touch Results to advance to the CTSIB Test Results screen m CTSIB Testing Tracing Test Trial Time 00 30 Trials 1 1 Prepare for Condition 2 Clear Tracing Eyes Closed Firm Surface Eyes Ope Firm Surf Trial 1 Complete Rest Countdown 3 D D TESTING 4 Atthe Results screen touch lt Print gt to automatically generate a printed report if desired To save the test data touch Save Results and then touch lt OK gt in response to the Save Results for later reporting or export prompt The system will display Save Results Completed after the results are saved Another test for the same patient can be performed Press Another Test Same Patient gt Pick desired test from the test selection menu To return to the Opening Menu from the CTSIB Test Results screen touch Home Note in the results if a patient could not complete a stage the stage is noted as Fell m CTSIB Test Results Sway Condition Index Sway Index
21. et al NEUROMUSCULAR TRAINING IMPROVES SINGLE LIMB STABILITY IN YOUNG FEMALE ATHLETES JOSPT Vol 34 6 305 316 June 2004 Biodex 92 245 PEREIRA HM et al INFLUENCE OF KNEE POSITION ON THE POSTURAL STABILITY INDEX REGISTERED BY THE BIODEX STABILITY SYSTEM Gait amp Posture Nov 2008 Vol 28 Issue 4 668 672 Biodex 92 293 PINTO KK et al THE EFFECTS OF ANKLE TAPING AND BALANCE ACTIVITIES ON BIODEX STABILITY MEASUREMENTS J of Athletic Training Vol 34 2 S 30 April June 1999 Biodex 91 102 RIEMANN BL et al COMPARISON OF THE ANKLE KNEE HIP AND TRUNK CORRECTIVE ACTION SHOWN DURING SINGLE LEG STANCE ON FIRM FOAM AND MULTIAXIAL SURFACES Arch Phys Med Rehabil Vol 84 90 95 January 2003 92 237 ROZZI SL et al KNEE JOINT LAXITY AND NEUROMUSCULAR CHARACTERISTICS OF MALE AND FEMALE SOCCER AND BASETBALL PLAYERS American J Sports Med Vol 27 3 312 319 May June 1999 Biodex 91 101 SCHMITZ RJ et al INTERTESTER AND INTRATESTER RELIABILITY OF A DYNAMIC BALANCE PROTOCOL USING THE BIODEX STABILITY SYSTEM J of Sports Rehab 7 95 101 1998 Biodex 93 271 APPENDIX G G 6 SIERI T and BERETTA G FALL RISK ASSESSMENT IN VERY OLD MALES AND FEMALES LIVING IN NURSING HOMES Disability and Rehabilitation 2004 Vol 26 No 12 718 723 Biodex 93 106 SIUDMAK PG et al CORRELATIONS BETWEEN DYNAMIC BALANCE PERFORMANCE AND ISOKINETIC FUNCTIONS OF KNEE FLEXOR EXTENSOR MUSCLES IN THE ELDER
22. muscles of the lower leg anterior tibialis and gastrocnemius are almost silent Studies have shown that when a walker is used the body largely abandons the ankle strategy and relies heavily on the hip strategy for balance This dependence on the hip strategy for balance paradoxically may lead to a decrease in ankle sway and contribute to fur ther decline in balance arising from loss of ankle strength and flexibility For this reason the pros and cons of walker use must be carefully considered before a walker is recommended for fulltime use Stepping Strategy The third strategy employed by the nervous system for balance is the stepping strategy This strategy is used when the loss of balance exceeds the area of stability and the person is forced to step or fall APPENDIX D D 2 SENSORY ORGANIZATION FOR BALANCE Perhaps the most confusing part of a balance evaluation is the part that examines the sensory sys tem and its contribution to balance The sensory system includes the eyes ears vestibular appara tus inner ear somatosensory system touch and proprioception taste and smell The parts of the sensory system that contribute directly to balance are the visual vestibular and somatosenso ry touch and proprioception systems The use of multiple systems in balance allows us to learn new movements quickly and to fine tune and easily repeat familiar movements The sensory system receives input from the environment through spec
23. of multiple visual cues For example a person may be safe walking in a quiet well lit hallway but be unable to negotiate a busy noisy hallway filled with people and equipment Vestibular damage or loss can also have a profound effect on balance and postural control Vestibular impairment can cause problems with gaze stabilization including blurred vision problems with balance and posture and vertigo Shumway Cook amp Woollacott 2001 Improper Sensory Selection Sensory loss may lead to inflexible or improper sensory weighting A person may depend on one particular sense for postural control even if that sense leads to further instability Shumway Cook amp Woollacott 2001 You may notice a person walking with head down care fully watching every step In this case vision is the dominant sense being used for balance Retraining would involve improving the use of somatosensory and vestibular input to reduce dependence on visual input APPENDIX D D 4 Abnormal Internal Representations Individuals perceptions of their limits of stability are difficult to assess and understand Illness and injury including stroke clearly affect confidence and may alter perceived stability limits A person s stability may be affected by fear of falling even when the physical ability exists to per form a task safely Conversely individuals may not have an accurate idea of the limits of their stability and thus have little warning when los
24. tion Print Test Results To print test results for any patient touch the desired test to generate an on screen report then touch Print to print the test results Single Patient Export To export the results of any saved test touch Export Data The data will immediately sent to the export program Single Patient Delete Although the Balance System SD display can store a significant number of test records you may want to decrease the number of stored records from time to time To delete any full page display of saved reports touch Delete Respond lt OK to the delete prompt The page displayed will be deleted from the display memory The delete function only works with pages you cannot select a specific test or patient to delete without deleting every test and patient displayed on the screen Multiple Patient Export See Figure 11 6 NOTE Store patient records on a USB memory device Manage view and print reports with Patient Data Collection Software Biodex part 4950 389 In addition to exporting any single patient record multiple patient records can be exported 1 At the Patient Management screen touch Multiple Export to export multiple patient records The Multiple Patient Data Export screen should now be displayed 2 Four options are available for multiple export all export all patient records prior to export all patient records prior to selected date from delete all patient records after a selected d
25. warranted to be within their specified accuracy at the time of shipment If a question arises and BIODEX MEDICAL SYSTEMS INC determines that the initial calibration is in error the instrument will be recalibrated at no charge B Mechanical products are warranted to meet written specifications and tolerances at the time of shipment C The return policy is as stated in paragraph 1 C 3 Warranty is non transferable 4 Non Warranty Service A Repairs and or replacements not covered by this warranty may be performed by BIODEX MEDICAL SYSTEMS INC at a factory authorized service location Estimates of repair charges may be requested however a charge for estimate preparation may apply if the repair is later not authorized by the customer B The cost of transportation into and out of the service location will be the responsibility of the customer IX BALANCE SYSTEM SD WARRANTY Service Procedure If you think you have a service problem take the following action 1 Check to see that the problem occurs more than once 2 Refer to the instruction manual and operations procedure 3 Refer to the instruction manual Troubleshooting Guide If you still think you have a service problem call BIODEX MEDICAL SYSTEMS INC Service Department at 800 224 6339 Keep yourself and the phone next to the equipment 1 Service will ask you for a brief description of the problem We will ask specific questions about the malfunction t
26. 2 supp S 78 April June 2001 Biodex 92 228 LAUFER Y et al EFFECT OF ATTENTION FOCUS ON ACQUSITION AND RETENTION OF POSTURAL CON TROL FOLLOWING ANKLE SPRAIN Arch Phys Med Rehabil Vol 88 Jan 2007 105 108 Biodex 92 285 LEONARD K et al CHANGES IN DYNAMIC POSTURAL STABILITY FOLLOWING CRYOTHERAPY TO THE ANKLE AND KNEE J of Athletic Training Vol 34 2 S 68 April June 1999 Biodex 91 107 LEPHART S et al LEARNING EFFECTS AND RELIABILITY OF THE BIODEX STABILITY SYSTEM Sports Medicine amp Neuromuscular Laboratory Univ of Pittsburgh Pittsburgh PA Biodex 93 208 PROPRIOCEPTION FOLLOWING ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION J of Sport Rehabilitation Vol 1 188 196 1992 Biodex 92 283 APPENDIX G G 4 THE ROLE OF PROPRIOCEPTION IN THE MANAGEMENT AND REHABILITATION OF ATHLETIC INJURIES The Am J of Sports Med Vol 25 No 1 130 137 1997 Biodex 92 284 LINDEMANN U et al IMPROVING BALANCE BY IMPROVING MOTOR SKILLS Z Gerontol Geriat 37 20 26 2004 Biodex 93 205 MAGILL J et al CHANGES IN DYNAMIC POSTURAL STABILITY WITH THE USE OF NEOPRENE SLEEVES J of Athletic Training Vol 34 2 S 30 April June 1999 Biodex 91 103 MALLEY C et al THE EFFECTS OF THREE DIFFERENT ANKLE TRAINING PROGRAMS ON FUNCTIONAL STABILITY AND SINGLE LIMB STANCE J of Athletic Training Vol 34 2 S 30 April June 1999 Biodex 491 105 MATTACOLA CG et al STRENGTH FUNCTIONAL OUTCOME
27. 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 3 2 Connect the power cable and USB cable to the rear of the printer ASSEMBLY amp INSTALLATION 3 2 PARTS AND ADJUSTMENTS See Figure 3 3 Mechanical adjustments to the Biodex Balance System are straightforward and uncomplicated In fact there are only three adjustments that need be addressed to accommodate any patient Support Handle Position Display Height and Display Tilt All other test and exercise functions are software controlled To Adjust the Support Handle 1 To position the Support Handle for patient use hold the Support Handle while pulling out on the Support Handle Release Pin Rotate the handle to the desired position Release the pin to lock the Support Handle in place 2 To release the Support Handle so that it cannot be used by the patient hold the handle while pulling out on the Support Handle Release Pin Fully lower the handle then release the pin Ajustement de l appui 1 Pour r gler l angle de l appui le tenir tout en tirant sur le verrou Trouver la position voulue rel cher le verrou pour garder la position ainsi trouv e 2 Pour carter l appui le baisser tou
28. 36 5 S30 Biodex 92 295 BEHAN E A COMPARISON OF A DYNAMIC BALANCE SYSTEM TO A STATIC FORCE PLAST SYS TEM FOR ORTHOPEDIC AND MUSCULOSKELETAL REHABILITATION Biodex Medical Systems Biodex 91 113 G 1 APPENDIX G wows BLACKBURN JT et al BALANCE AND JOINT STABILITY THE RELATIVE CONTRIBUTIONS OF PROPRIOCEPTION AND MUSCULAR STRENGTH J of Athletic Training Vol 34 2 S 30 April June 1999 Biodex 91 104 BLACKBURN TA et al SINGLE LEG STANCE DEVELOPMENT OF RELIABLE TESTING PROCEDURE Berkshire Institute of Orthopedic amp Sports Physical Therapy Wyomissing PA Biodex 93 207 REHABILITATION AFTER LIGAMENTOUS AND LABRAL SURGERY OF THE SHOULDER GUIDING CONCEPTS J of Athletic Training 2000 35 3 373 381 Biodex 93 111 CACHUPE WJC et al RELIABILITY OF BIODEX BALANCE SYSTEM MEASURES Human Performance Dept San Jose State University June 2000 Biodex 491 198 CAGGIANO NA et al THE RELATIONSHIP BETWEEN ANKLE KINESTHESIA AND PEAK TORQUE WITH SINGLE LEG MULTIAXIAL PLATFORM STABILITY J of Athletic Training Vol 34 2 S 31 April June 1999 Biodex 91 106 CAKAR E et al THE ANKLE FOOT ORTHOSIS IMPROVES BALANCE AND REDUCES FALL RISK OF CHRONIC SPASTIC HEMIPARETIC PATIENTS Eur J Phys Rehabil Med 2010 Vol 46 No 3 363 368 Biodex 92 290 JUMPING COMBINED EXERCISE PROGRAMS REDUCE FALL RISK AND IMPROVE BALANCE AND LIFE QUALITY OF ELDERLY PEOPLE WHO LIVE IN A LONG TERM CARE FACILITY Eur
29. 4 20x 75 LG 4 REA OCD COB00 LOTITE BLUE REF 950 300 W205 WELOMENT 08805 C ANCE CONTROL MODULE BALCNTRLMLDASSY950 300 A030 J SELDER PADS LEICA 12906 L 0Ih NE RER I 4 18 LT SENSOR EU 2 REN D Y 1 REDD 0x50 LG 2 RED 2 REID M NIG 2 REID UT HO 3 8 16x1 50 LG Ru CATION 25 SPROCKET 14 1 ROUNZE BRG 1 REND RUST 03 THK CDRER D Wy WASHER D WM WAM Is CA CKET 19T CREDE D ROLLER CHAIN 4 25 441 D REID SHORT SHUARE KEY C3RER D gt H 10 32NFx 18 6 6 REID O ITE ELLE RE D 5 16 18x 50 LG TK 5 16 CERERI D R FLAT 8 REG 8421 SCR HEX HD 4 20x 50 LG 4 REV HER LOCK 08938 8 REN 050 3 PLATE SPRING 1 REI D T 3 8 16x 75 LG GRAD j i j M305 ALME SCREW d NURSE SES RING SPA E IND MARKING FLUSH ON TOP OF BOLT 8 REF APPLIED TO HEAD OF BOLT TYP iu M367 NUT MODIFIED ACME 3 SUPER LUBE REF 945 300 M317 SPRING PLATE 350 300 C30 Y ACHE SCREW AS RED ST WASHER amp FRAM 12 RFID AINING COMPOUND A R GA ITA ALCOHOL PRIDR To RAME SLPPERT 3 RET D IN BEARING 3 REU D WITH BOTTOM KT ASSY CL REM REPLACEMENT R 8 BIODEX
30. A minimum of three test trials should be used to avoid excessive balance deviations The patient s performance is noted as a stability index Test results are compared to age depend ent normative data Scores higher than normative values suggest further assessment for lower extremity strength proprioception and vestibular or visual deficiencies Poor balance is a major contributor to falls Strength particularly high speed and proprioceptive training have demon strated positive results in balance improvement NOTE For information on normative data referenced in the Predictive Values Report see Appendix C NOTE For information comparing the original Balance System Protocol for Fall Risk Balance Testing to the Balance System SD Protocol for Fall Risk Balance Testing see note and chart page B 1 References 1 Finn JA et al Biodex Balance System Assessment Amoung Subjects of Disparate Balancing Abilities Presented at the 1999 American College of Sports Medicine Meeting Updated May 2010 8 17 TESTING CLINICAL TEST OF SENSORY INTEGRATION AND BALANCE CTSIB OR m CTSIB MODIFIED CTSIB The Clinical Test of Sensory Interaction and Balance CTSIB is standardized test for Balance assess ment on a static surface The CTSIB test protocol is well documented in the literature as an effective test for identifying individuals with mild to severe balance problems The CTSIB consists of six con ditions The test provides a generalized a
31. AND POSTURAL STABILITY CRUCITATE LIGAMENT RECONSTRUCTION J of Athletic Training Vol 37 3 262 268 July Sept 2002 Biodex 92 241 MELZER I et al POSTURAL STABILITY IN THE ELDERLY A COMPARISON BETWEEN FALLERS AND NON FALLERS Age and Ageing 2004 33 6 602 7 Biodex 492 288 Abstract MYER GD et al REHABILITATION AFTER ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION CRITE RIA BASED PROGRESSION THROUGH THE RETURN TO SPORT PHASE J of Orthop amp Sports Phy Ther 36 6 385 402 June 2006 Biodex 93 117 NELSON AJ et al USING THE BIODEX UNWEIGHING SYSTEM BALANCE SYSTEM AND GAIT TRAINER IN AN INTEGRATED REHABILITATION PROGRAM Abstract May 2001 Biodex 92 217 PAJALA S et al FORCE PLATFORM BALANCE MEASURES AS PRDICTORS OF INDOOR AND OUTDOOR FALLS IN COMMUNITY DWELLING WOMEN AGED 63 76 YEARS J Gerontol A Biol Sci Med Sci 2008 63 2 171 8 Biodex 492 289 Abstract G 5 APPENDIX G PALM H G et al THE ROLE AND INTERACTION OF VISUAL AND AUDITORY AFFERENTS IN POSTURAL STABILITY Gait amp Posture Oct 2009 Vol 30 Issue 3 328 333 Biodex 92 296 PARRACA J et al TEST RETEST RELIABILITY OF BIODEX BALANCE SD ON PHYSICALLY ACTIVE OLD PEOPLE Journal of Human Sport amp Exercise 2011 issue 2 vol 8 444 451 Biodex 92 287 PATERNO MV et al THE RETURN OF NEUROMUSCULAR COORDINATION AFTER ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION Biodex Medical Systems Biodex 491 112 PATERNO MV
32. BALANCE SYSTEM SD OPERATION SERVICE MANUAL 950 440 950 441 950 444 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 com FN 10 205 Rev C 2 14 BALANCE SYSTEM This manual covers installation and operation procedures for the following products 3950 440 System Balance SD 115 VAC 950 441 System Balance SD 230 VAC 950 444 System Balance SD 100 VAC A CAUTION Federal law restricts this device to sale or on the order of a medical practitioner When prescribed for therapeutic purpose a physician should clearly define the parameters of use i e total work maximum heart rate etc to reduce the risk of patient injury A ATTENTION Droit f d ral limite ce dispositif la vente ou de l ordre de la profession m dicale Lorsque prescrits des fins th rapeutiques un m decin devrait clairement d finir les param tres d utilisation p ex total travail fr quence cardiaque maximale etc afin de r duire le risque de blessure de patient TABLE OF CONTENTS Before Proceedings iei ditor teeth oerte eed edes t tius IV Definition ot Symbols sesion iura a e E pA EERE citati e it une V 1r Tnttod elon Re n cond ramis five ti ei en at mes 1 1 2 oystenm SpectficatiODS i rre ere datei ONU ER Preterea eei Ren eet ii p teens date osent 2 1 3 Assembly and Installation p peii n OPI PR UR E
33. BALANCING ABILITIES Southern Connecticut State University 501 Crescent St New Haven CT 06515 Phone 203 392 6036 Biodex 93 286 FLYNN WL et al CHANGES IN DYNAMIC POSTURAL STABILITY FOLLOWING CRYOTHERAPY J of Athletic Training Vol 32 2 S 6 April June 1997 Biodex 91 110 FREIDHOFF G et al PILOT ASSESSMENT OF THE BIODEX STABILITY SYSTEM WITH NORMALS TEST RETEST AND DAY TO DAY RELIABILITY University of Kentucky Div of P T Med Center Annex I Lexington KY Biodex 93 206 G 3 APPENDIX G HANDRAKIS JP STATIC STRETCHING DOES NOT IMPAIR PERFORMANCE IN ACTIVE MIDDLE AGED ADULTS Journal of Strength amp Conditioning Research March 2010 Volume 24 Issue 3 pp 825 830 Biodex 92 294 HINMAN MR FACTOS AFFECTING RELIABILITY OF THE BIODEX BALANCE SYSTEM A SUMMARY OF FOUR STUDIES J of Sport Rehab Vol 9 3 240 52 August 2000 Biodex 91 194 HORNYIK ML et al RELIABILITY OF LIMITS OF STABILITY TESTING A COMPARISON OF TWO DYNAMIC POSTURAL STABILITY EVALUATION DEVICES J of Athletic Training Vol 36 2 supp S78 April June 2001 Biodex 92 229 HORODYSKI MB et al MEASUREMENTS OF DYNAMIC POSTURAL STABILITY VISUAL SCANNING AND MEN TAL FLEXIBILITY IN COLLEGIATE FOOTBALL PLAYERS J of Athletic Training Vol 34 2 585 April June 1999 Biodex 91 108 JORDEN RA et al THE INFLUENCE OF ANKLE ORTHOSES AND EXERCISE ON POSTURAL STABILITY J of Athletic Training Vol 36
34. CTSIB Age Range screen to return to the m CTSIB Defaults screen To Add an Age Range 1 At the Configuration Screen touch lt m CTSIB Defaults gt The m CTSIB Defaults screen will now be displayed 2 Select Age Range gt 3 Select the lt Add gt Age Range button at the bottom of the screen 4 A new Age Range screen will appear The From and To values in the range will also appear on the screen 5 Select the value you would like to set Adjust the value using the lt A gt or lt W gt arrows or the key pad displayed 6 Press lt OK to save the new age range and return to the m CTSIB Age Range screen 7 Press lt OK gt from the m CTSIB Age Range screen to return to the m CTSIB Defaults screen CHANGE ACCESS ID CODE At the Default Settings screen users can change the Access Code used to access the Default Settings screen To Change the Access ID Code 1 At the Configuration Screen touch Change Access ID Code gt 2 Select your New Access ID Code by entering the value using the lt A gt or lt Y gt arrows or the key pad displayed 3 Press lt OK to save the New Access ID Code and return to the Default Settings screen 11 5 SYSTEM UTILITIES Turn Tone ON OFF This setting enables or disables an audible tone which signals test or exercise start completion and countdown between trials 1 Atthe Configuration screen simply touch the ON or OFF icon to select the desired setting Adjust LCD Brightne
35. LY Biodex 93 295 TESTERMAN C et al EVALUATION OF ANKLE INSTABILITY USING THE BIODEX STABILITY SYSTEM Foot Ankle Int 1999 May 20 5 317 21 ISSN 1071 1007 Biodex 91 116 UUSI RASI K et al ASSOCIATIONS OF CALCIUM INTAKE AND PHYSICAL ACTIVITY WITH BONE DENSITY AND SIZE IN PREMENOPAUSAL AND POSTMENOPAUSAL WOMEN A PERIPHERAL QUANTITATIVE COMPUTED TOMOGRAPHY STUDY J of Bone and Mineral Research Vol 17 No 3 2002 544 552 Biodex 92 281 WILKERSON GB DYNAMIC JOINT STABILITY MECHANICAL AND NEUROMUSCULAR INTER RELATIONSHIPS Biodex Medical Systems Biodex 91 109 WINTERS KM et al DETRAINING REVERSES POSITIVE EFFECTS OF EXERCISE ON THE MUSCULOSKELETAL SYSTEM IN PREMENOPAUSAL WOMEN J of Bone and Mineral Research Vol 15 No 12 2000 2495 2503 Biodex 92 280 rev Aug 2 2012 G 7 APPENDIX G REPLACEMENT R 1 REPLACEMENT Gr id MM 18 ASN d TWO J T l Ag d OS CO dd d Add OSHS lf LI TAN 2680 i ME 1 IREN EU Her 1 1219 pu d Al HH 113 B R 2 REPLACEMENT OU A1 S097 0 MINT 7 LUN Gerad dil 580 dS ETE EX CT ED NAS VLrc 00E 066 REPLACEMENT Pes SCR SIC FLAT HD 1
36. OLS N BEFORE PROCEEDING e This system should be operated only by qualified personnel Ensure that all system wiring and cables are routed away from any area where they might be stepped on or rolled over by wheeled equipment A CAUTION To avoid risk of electric shock this equipment must only be connected to a supply mains with protective earth ATTENTION Pour viter le risque de choc lectrique cet quipement doit uniquement tre con nect un approvisionnement conduites avec la terre protectrice e The plug is considered the method of disconnecting the product from mains power Do not place the product in a position where the plug is not easily accessible e Connecting electrical equipment to power outlet on the back of the unit effectively leads to creat ing a medical electrical system and can result in a reduced level of safety This outlet is intended only for use with an approved printer equipped with an IEC cord see System Specifications list e Be aware that use of Biodex technology requires professional expertise for discerning appro priate treatment techniques Each subject s unique situation should be taken into account before beginning any type of testing or rehabilitation program Be sure you fully comprehend the operating instructions as well as the considerations both physical and clinical discussed throughout the manual before attempting to set up a subject for testing or exercise Practice
37. RAINING See Figure 7 2 The Postural Stability Training mode is designed to emphasize specific movement patterns or strategies by placing markers anywhere on the screen grid The patient s score is a tally of how many times the patient can touch targets with the on screen cursor during any session Time counts up or down as set Postural Stability Training rime 00 00 Score 0 STATIC Place Target G x lear T D a R Clear Tracing Press START to Begin D Figure 7 2 The Postural Stability Training screen e To Access The Postural Stability Mode 1 Position the support handles as per patient protocol 2 Position the display height and tilt for patient comfort 3 Atthe Main Menu touch Training The Training Menu screen should now be displayed 4 Touch Postural Stability gt The User Setup Information screen should now be displayed If this is a new patient and you want to save this training session after its completion you must enter the patient s name height and weight If you do not need to save the training session touch lt Next gt and skip to step 8 5 Touch the Keypad icon for Name and enter the patient s name Touch lt OK gt to return to the User Information screen 6 Touch the lt Keypad gt icon for Age and enter the patient s age Touch lt OK to return to the User Information screen 7 Touch the Keypad icon for Height and enter the patient s
38. RE HIS EERE EEEE 3 1 Printer Installation Parts and Adjustments 4 Clinical Considera Hong a cidit nidos p etti bereiten 4 1 General Clinical Considerations Additional Considerations for Fall Risk Screening and Conditioning Program bi Applications iasueni tubi Radiata RI HU Rer niece i Re e n sameness 5 1 Orthopedic and Sports Medicine Fall Prevention Reference Notes 6 iniri 9 6 1 Accessing the Main Menu Display Panel Keys Described e Screen Keys 2 The Dinh ROMANE cosas iin a nint ne aM dai mu anne 7 1 Postural Stability Training Limits of Stability LOS Training Weight Shift Training Maze Control Training Random Control Training Percent Weight Bearing Training Create Save and Recall Custom Protocols E DE 8 1 The Postural Stability Test The Limits of Stability Test Athlete Single Leg Stability Testing Performing a Fall Risk Test Clinical Test of Sensory Integration and Balance CTSIB overview EB E LoS e r nn brin niet es terne tn inertie eine nait einen ttes 9 1 Report Parameters Defined Progress Reports Sample Balance Reports MP T 10 1 Assessing Limits of Stability With The Biodex Balance System Understanding Patient Performance Balance System Statistics Defined Changing Normative Data Default IEEE e 11 1 Cong UrdHOD sssrin to ies manti nee 11 2 e Patient Managemen
39. RMANCE The patient s performance is noted in the following ways 1 Stability Index The stability index represents the variance of platform displacement in degrees from level A high number is indicative of a lot of motion which is indicative of the patients having trouble balancing Differences between right and left limbs can be noted 2 Percent Time in Zone Quadrant Example If a patient with a right lateral ankle sprain spends the vast majority of time in Zone 1 the trend will be to fall into inversion This gives feedback as to the exact ankle position being challenged 3 Test Grid For testing as the patient goes further and further from the center of axis the patient is being challenged to sustain proper position For rehabilitation we can note how far the patient can deviate from the center and still maintain a proper position 105 DATA BALANCE SYSTEM STATISTIC DEFINITIONS Stability Index Represents the variance of platform displacement in degrees from level A high number is indicative of the patient having trouble balancing The patient s Actual Stability Index is represented in the Postural Stability Athletic Single Leg and Fall Risk Report under the col umn labeled Actual Score The Actual Score can be compared to age related Predictive Score this is found to the immediate left of the Actual Score under the column labeled Predictive Values Should your patient s Actual Values not fit into the range of t
40. STABILITY TESTING This test protocol can be used to compare patients of similar age ranges in a normative database Test Duration 20 seconds Level Four Stance Type Single leg Trials 3 References prr Single Leg Stability Test results compliation of data from Paterno MV et al Neuromuscular Training Improves Single Limb Stability in Young Female Athletes J Orthopedic Sports Therapy June 2004 e Arnold BL Schmitz R Examination of Balance Measures Produced by the Biodex Stability System J of Athletic Training 1998 33 4 323 327 e Rozzi S et al Knee Joint Laxity and Neuromuscular Characteristics of Male and Female Soccer and Basketball Players American J Sports Medicine Vol 27 No 3 1999 8 13 TESTING PERFORMING A FALL RISK TEST The Fall Risk test allows identification of potential fall candidates Test results are compared to age dependent normative data Scores higher than normative values suggest further assessment for lower extremity strength proprioception and vestibular or visual deficiencies Fall Risk Testing Test Trial Time e 00 20 Trials 8 Tracing Score 0 0 Platform Setting Clear Tracing 12 Press START to Release Platform Back Figure 8 12 The Fall Risk Testing screen Fall Risk Testing Options Number of Trials Rest Countdown Initial Platform Ending Platform 5 CR lt gt 2 Cancel OK Figure 8 13 The Fall Risk Testing Options screen TESTING 8 14
41. Time in Time in Quadrant 9 11 40 Quadrant 26 6 m 30 iv 21 m 4 iw 64 Back Print Save Results Home Figure 8 5 A sample Postural Stability Test Results screen for a bilateral test 8 amp 3 TESTING PERFORMING A POSTURAL STABILITY TEST See Figures 8 2 and 8 6 2 10 11 12 13 Position support handles as per patient protocol Position display height and tilt for patient comfort At the Main Menu touch Testing The Testing Menu screen should now be displayed Touch Postural Stability The User Setup Information screen should now be displayed Touch the Keypad icon for Name and enter the patient s name Touch lt OK gt to return to the User Setup Information screen Touch the Keypad icon for Age and then enter the patient s age Touch lt OK gt to return to the User Setup Information screen Touch the appropriate lt Height gt key to highlight the patient height range setting desired Touch lt Next gt to advance to the Patient Position screen Position the patient on the system and explain the test protocol Press Start on the display to activate the cursor and have the patient move the cursor to the center point on the grid Touch Record to bring up the Position Patient Entry screen Using the keypads enter the patient s left foot left heel right foot and right heel positions using the midline of the foot and the platform grid as reference points Touch lt Next
42. YSTEM UTILITIES 12 REIMBURSEMENT Biodex Rehabilitation Equipment is commonly used in rehabilitation services based on a physician referral for these ICD 9 codes As a result these CPT codes may be applied Reimbursement amounts vary among plans and states Physician referral and ICD 9 codes V15 88 728 87 729 89 715 0 715 2 781 2 719 7 719 4 719 5 718 8 780 40 781 20 850 00 850 10 850 11 850 12 850 50 850 90 310 20 Personal History of Fall Muscle weakness Leg weakness Degenerative joint disease Secondary localized osteoarthritis Abnormal gait Difficulty in walking Joint pain Joint stiffness Instability of joint Dizziness Imbalance Concussion without LOC Concussion with brief LOC Concussion with LOC lt 30 minutes Concussion LOC 31 to 59 minutes Concussion with unspecified duration of LOC Concussion unspecified NOS Post concussion Syndrome PCS The following CPT codes can be applied Reimbursement amounts vary among plans and states 97110 97112 97116 97530 97535 97750 96992 Therapeutic procedure one or more areas each 15 minutes therapeutic exercise to develop strength endurance range of motion and flexibility Neuromuscular reeducation of movement balance coordination kinesthetic sense posture and or proprioception for sitting and or standing activities Gait Training includes stair climbing Therapeutic activities direct one on one patient contact by the pro
43. age of weight bear ing on the patient s foot ankle knee hip body side etc In this mode targets can be set that encourage patients to focus on weight bearing goals in anterior posterior medial and lateral movements Therapists and patients should find weight bearing training to be an effective mode for communicating what where and how a patient s body weight is located or feels Q Percent Weight Bearing Training ien rime 0 00 75 Score 0 100 50 100 25 so 75 100 Press START to Begin D Back Figure 7 7 The Percent Weight Bearing Training screen NOTE Scoring is the percent time spent within the target range The axis will show green when weight bearing is within target settings If desired shift the red Percent Weight Bearing target zone by touching and dragging the appropriate red line to the desired Percent Weight Bearing target Percent Weight Bearing Training e rime 00 00 Score 0 100 50 50 100 Press START to Begin o Back Figure 7 8 If desired use the More Options button to set the training grid to medial lateral only 7 13 THE TRAINING MODES To Access The Weight Bearing Training Mode NOTE Weight Bearing is used with the platform in static mode only 1 2 10 11 12 13 Position the support handles as per patient protocol Position the display height and position for patient comfort At the Main Menu touch T
44. aining Time 00 00 gt Full a 3 _ Pattern 3 3 C Skill Level 3 Clear Tracing STATIC 29 o 9 amp D Y Back Figure 7 3 The Limits of Stability LOS Training Screen To Access The Limits of Stability Training Mode 1 Position the support handles as per patient protocol 2 Position the display height and tilt for patient comfort 3 Atthe Main Menu touch Training The Training Menu screen should now be displayed 4 Touch Limits of Stability gt The User Setup Information screen should now be displayed If this is a new patient and you want to save this training session after its completion you must enter the patient s name height and weight If you do not need to save the training session touch lt Next gt and skip to step 8 5 Touch the lt Keypad gt icon for Name and enter the patient s name Touch lt OK to return to the User Information screen 6 Touch the lt Keypad gt icon for Age and enter the patient s age Touch lt OK to return to the User Information screen THE TRAINING MODES 7 4 10 11 12 13 14 15 16 17 Touch the lt Keypad gt icon for Height and enter the patient s height Touch Next to advance to the Limits of Stability Training screen At the Limits of Stability Training screen touch lt Stance gt to toggle though the patient stance positions until the desired choice right leg left leg or both legs is displayed
45. am Surface Eyes Open vs Eyes Closed With Eyes open on an unstable surface normal individuals have significantly more sway then when standing on a firm surface And even more sway on the unstable surface with their eyes closed However they do not become overly unstable or fall Patients that do become unstable or fall when standing on foam with eyes open may have difficultly using visual information for balance control and or may have lower extremity musculoskeletal problems A hip strategy should be used on unstable surfaces NOTE These tests are targeting sensory integration deficits Standing on an unstable surface presents biomechanical and musculoskeletal challenges Patient with ankle or foot problems joint weakness or pain will have high scores As such in these patients it can not be assumed that sensory abnormalities are the underlying cause as they can not be distinguished from motor musculoskeletal issues Ideally patient should be screen for motor problems prior to the CTSIB test Only patients without motor problems should be tested with the CTSIB The LOS test is an effective test to tease out this question APPENDIX D D 6 APPENDIX E ELECTROMAGNETIC COMPATIBILITY This equipment conforms to the following safety standards 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 a
46. ard direction causes contraction of the gastrocnemius hamstrings and lower back muscles in that order to bring the body back into balance D APPENDIX D Posterior Anterior Sway Sway Figures D 1 and D 2 The ankle strategy that is used in response to small perturbations is also called ankle sway Illustration Wild Iris Medical Education A small loss of balance in the backward direction causes contraction of the anterior tibialis quadri ceps and lower abdominal muscles in that order to bring the body back into balance Our bodies are constantly using this strategy to adjust for minor losses of balance For example you would use the ankle strategy to maintain balance when standing on a bus to correct for losses of balance and to prevent yourself from falling as the bus changes speed You might also use the ankle strate gy to maintain your balance on a very soft surface such as thick grass or a piece of foam Hip Strategy The hip strategy describes movement about the hip in response to larger losses of balance or when the support surface does not allow the use of the ankle lever such as on an icy surface or when the surface is shorter than the length of the foot In the hip strategy activation of muscles is from the trunk down or proximal to distal A loss of balance in the forward direction causes contraction of the lower back and hamstring muscles in that order to regain balance When the hip strategy is used the
47. ate and from to export all records between selected dates Touch Options until the desired option is displayed For prior to and from to touch the date displayed to advance to the date screen Touch the date section to change and use the lt A gt or lt W gt arrows to adjust 3 Touch Export Now gt to export the selected patient files SYSTEM UTILITIES Multiple Patient Data Delete Total Data Records Stored 22 option Prior To 08 01 2010 D Back Delete Figure 11 6 For multiple export or multiple deletion of patient records touch Option to select records based before or after a selected date or between two selected dates Multiple Patient Delete In addition to deleting any single patient record multiple patient records can be deleted 1 Atthe Patient Management screen touch Multiple Delete gt to delete multiple patient records The Multiple Patient Data Delete screen should now be displayed 2 Three options are available for multiple delete all delete all patient records prior to delete all patient records prior to selected date and from to delete all records between selected dates Touch Options until the desired option is displayed e For prior to and from to touch the date displayed to advance to the date screen Touch the date section to change and use the lt A gt or lt W gt arrows to adjust 3 Touch Delete Now to delete the selected patient files 11 9 S
48. ble to the frequency of the trans mitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorp tion and reflection from structures objects and people Operating Temperature Do not expose the equipment to a temperature change of more than 5 F 3 C per hour Limits of low and high operating temperature ranges are 59 to 86 F 15 C to 30 C APPENDIX E E4 APPENDIX F CLEANING AND MAINTENANCE General Maintenance The Biodex Balance SD requires only the most basic general maintenance performed on an as needed basis at least every three to four months Cleaning Instructions With the system turned OFF wipe down all surfaces with a damp cloth Mild soap and water can be used to remove stains and scuff marks As needed inspect all locking and adjustment mechanisms for signs of wear or damage If you have any questions or need further assistance contact the Biodex Customer Service Department CAUTION Some steps of these procedures require the Balance SD to be turned ON When this is N the case use extreme caution working on the system f ATTENTION Certaines tapes de la pr sente marche suivre n cessitent que le syst me d quili brage soit mi
49. center thus a lower score is more desirable than a higher score Platform stability can be varied during a this test by selecting More Options from the Postural Stability Testing screen Clinicians can also set trial time number of trials starting and ending platform stability rest countdowns or bilateral test Position Patient Stance 2 Both Left Foot Angle Right Foot Angle aa LT Right Heel Left Heel amp Accept foot placement as shown or Enter new centered foot postion and confirm Home Confirm Figure 8 2 The Patient Position screen with patient positions entered Postural Stability Testing Options Number of Trials Rest Countdown Initial Platform Ending Platform s BeA 0 v oK a e Figure 8 3 The Postural Stability Testing Options screen TESTING 8 2 Postural Stability Testing Q Test Trial Time 00 20 Trials 3 Tracing Score 0 0 Platform Setting Static Clear Tracing Press START to Release Platform lt b 2 Back Home Figure 8 4 The Postural Stability Testing screen Postural Stability Test Results Left Leg Results Right Leg Results Actual STD Actual STD Score Dev Score Dev Overall Stability Overall Stability Index 1 4 1 23 Index 1 8 2 70 Anterior Posterior Anterior Posterior Index 1 2 1 26 Index 1 5 2 35 Medial Lateral Medial Lateral Index 0 5 0 44 Index 0 6 1 50 Ti i Ti i en A 98 m 2 Je A OA n 3 coo nio 6 2 n0 1
50. cep tion Orthopedic changes include loss of ankle sway leading to an increase in the use of the hip and stepping strategies and lower foot swing height Psychomotor changes include loss of confi dence changes in the perceived limits of stability and a propensity to fall in new or novel situa tions perhaps due to impaired anticipatory mechanisms Sensory changes include abnormal sensation i e peripheral neuropathies abnormal tone effects of drugs visual disturbance such as hemianopsia and a reduction in the function of the vestibular system of the inner ear Shumway Cook and Woollacott 2001 D 5 APPENDIX D CTSIB TEST RESULT INTERPRETATION Neurocom The CTSIB is the Clinical Test for Sensory Integration and Balance The CTSIB is the standard test for differentiating balance problems as a result of visual vestibular or somatosensory The CTSIB uses 4 conditions to test contribution of visual vestibular and somatosensory inputs 1 Eyes Open firm surface This is the baseline condition Accurate information is available to all three sensory systems visual vestibular and somatosensory Normal individuals are very stable in this condition 2 Eyes Closed Firm surface No visual input is available The Patient must rely on somatosen sory and vestibular inputs Somatosensory is the primary sensory input Vestibular inputs are secondary High sway scores are indicative of problems with somatosensory In normal indi vid
51. countdown before beginning the first test trial The display screen will show Test Trial Time and Platform Setting to the left of the grid Trial Number and score are dis played to the right of the grid NOTE To stop a test in progress at any time and return to the Fall Risk Testing screen with the platform locked touch Cancel or Stop When the first trial is finished the screen will display Trial 1 Complete the platform will return to the locked position and the rest countdown will begin for the second trial Touch Collect Data gt to begin the second test trial and continue in the same manner to complete trials two and three After completing the test a Test Complete message is displayed Touch lt Results gt to advance to the Fall Risk Test Results screen At the Fall Risk Test Results screen touch Print to automatically generate a printed report if desired To save the test data touch Save Results and then touch lt OK gt in response to the Save Results for later reporting or export prompt The system will display Save Results Completed after the results are saved To return to the Opening Menu from the Fall Risk Test Results screen touch lt Home gt TESTING 8 16 BALANCE SYSTEM SD PROTOCOL FOR FALL RISK BALANCE TESTING This test protocol can be used to compare patients of similar age ranges in a normative database Test Duration 20 seconds Level 12 to 8 Stance Type Bilateral
52. d Touch lt Record gt to bring up the Position Patient Entry screen Using the keypads enter the patient s left foot left heel right foot and right heel positions using the midline of the foot and the platform grid as reference points Touch lt Next gt to advance to the Limits of Stability Testing screen At the Limits of Stability Testing screen touch lt Stance gt to scroll through the three stance positions provided left right or both Touch lt Tracing gt to toggle tracing ON or OFF as desired TESTING 8 8 12 13 14 15 16 17 18 19 20 Touch Clear Tracing gt to clear any tracing that remains from previous tests Touch More Options to advance to the Limits of Stability Test Options screen if desired Here you can set the number of trials rest countdown platform stability and limits of stabil ity hold time You can also toggle the cursor ON OFF Touch lt OK to confirm your selec tions and return to the Limits of Stability Testing screen e Use the lt A gt or lt W gt keys to set the Limits of Stability Hold Time e To turn the cursor ON OFF touch Cursor to toggle between choices e To set number of trials rest countdown or platform stability static 12 is most stable 1 is least stable touch the appropriate key and then enter the setting from the keypad displayed Press Start to release the platform if not static and activate the Limits of Stability Te
53. d in Appendix A2 NOTE A standardized indexed foam pad that matches the size of the Balance SD platform is provided The foam pad should be used for the dynamic foam surface conditions in the CTSIB test TESTING 8 18 PERFORMING A CTSIB To perform the CTSIB test simply follow screen prompts 1 Select the m CTSIB from the test screen menu 2 Address each screen as you progress through the menus The default test conditions are four m CTSIB conditions Testing Postural Stability Limits of Stability m CTSIB Athlete Single Leg D eo Back Select Custom Protocol Test information Position Patient Position the patient s feet as noted If patient cannot be positioned as suggested center patient and enter new foot position The foot angle is determined by the line that is parallel with the inside of the foot NOTE Foot placement is based on height 53 defaults to a foot angle of 10 10 and Heel position of F7 F15 respectively 53 59 defaults to a foot angle of 10 10 and Heel position of E7 E15 respectively 59 65 and 65 73 default to a foot angle of 10 10 and Heel position of D67 D16 respectively 73 defaults to a foot angle of 10 10 and Heel position of C5 C17 respectively Position Patient Stance Both Left Foot Angle Right Foot Angle i i y Left Heel E Ea NS ROAY AA A Right Heel TX or t ji 6 D6 e ss pte Accept foot placement as shown or Enter new centered foot po
54. d to save the training session touch lt Next gt and skip to step 8 THE TRAINING MODES 7 6 10 11 12 13 14 15 16 17 Touch the Keypad icon for Name and enter the patient s name Touch OK to return to the User Information screen Touch the lt Keypad gt icon for Age and enter the patient s age Touch lt OK to return to the User Information screen Touch the lt Keypad gt icon for Height and enter the patient s height Touch lt Next gt to advance to the Weight Shift Training screen At the Weight Shift Training screen touch lt Rotate Target gt to toggle through the three patient target positions until the desired rotation is displayed on the grid Touch Skill Level gt to enlarge or decrease the target box size Three skill levels are available from which to choose Touch Skill Level gt until the desired target configuration is displayed If desired touch Clear Tracing gt to remove any tracing that remains on the screen from a previous exercise session Touch More Options to advance to the Weight Shift Training Options screen if desired Here you can set the total hits for the exercise default 60 set platform stability and turn tracing ON OFF Touch lt OK gt to confirm your selections and return to the Weight Shift Training Options screen or Cancel to return to the Weight Shift Training Options screen without making changes e Use the lt A gt or l
55. dvance to the locked position 15 When you are finished reviewing the Maze Control Training screen touch lt Print gt to print the screen or lt Save Results gt to save the training session numeric data only 16 After printing or reviewing the screen press lt Start gt to immediately begin another training session using the same parameters or press lt Back gt to return to the Training Setup screen THE TRAINING MODES 7 10 THE RANDOM CONTROL TRAINING This training mode allows the patient to perform neuromuscular control activities in random pat terns generated by the display and is ideal for motor control and vestibular training The size and speed of the target can be modified for progressions ranging from easy to difficult While in static mode the patient can work within their sway envelope to move the cursor and attempt to keep it within the moving target In dynamic mode the patient must utilize various hip knee and ankle strategies to manipulate the moving platform s cursor to within the random moving target Scoring is percentage based and equals the total time inside the circle total time in and outside of the circle Time counts up or down as set Random Control Training time 00 03 Score 33 m Circle Speed Skill Level Clear Tracing Press STOP to End Figure 7 6 The Random Control Training screen To Access The Random Control Training Mode 1 Position the support handles as per patient pr
56. e 3D glasses or clear safety glasses in which the lenses have been marred or covered with Scotch type tape What is being measured during the CTSIB test e Sway Index Stability Index The Sway Index is really the Standard deviation of the Stability index The higher the Sway Index The more unsteady the person was during the test The Sway Index is an objective quantification of what commonly is done with a time based pass fail for completing the CTSIB stage in 30 seconds without falling or assigning a value of 1 to 4 to characterize the sway 1 minimal sway 4 a fall The Stability Index is the average position from center The Stability index does not indicate how much the patient swayed only their position Consider the following example If a patient is positioned in a manner that biases their placement from the center the stability index will be a large value However if they swayed very little the standard deviation would be low This is evident when you see the COG plots A patient could have a score of 6 5 yet their standard deviation would only be 8 The printout tracing will show they did not sway very much However if they were positioned off center or even on center and they swayed a lot the standard deviation would be higher Thus the standard deviation is indicative of sway If a patient cannot complete a condition it is noted as Fell on results screen and report Specific information on Stability index can be foun
57. e 11 1 When the screen is dark and the unit is plugged into wall current just touch the screen and the last viewed screen will be presented SCREEN KEYS The following on screen touch keys are consistent whenever they appear throughout the entire Balance System SD program lt HOME gt Touch this key to return to the Main Menu NEXT Touch this key to advance to the next logical screen lt BACK gt Touch this key to return to the previous screen lt OK gt Touch this key to confirm selections or entries and advance to the next screen BALANCE SYSTEM SD Training Testing qe Utilities Figure 6 1 The Balance System Main Menu 6 1 GETTING STARTED 7 THE TRAINING MODES The training modes provide a simple means of setting up a training or exercise session Six interactive game like training modes are provided These allow for fast patient setups less for mal protocols than the testing routines and the ability to change stability level from very unsta ble to static during the actual training session All six training modes can be customized to pro vide specific rehab goals with the on screen grid and score keeping functions used to both help motivate users and keep them focused on the task at hand In training mode only the most basic parameters are addressed If desired a pre existing patient can be recalled from the Test Rehab Results option in Patient Maintenance menu to allow for quick and easy re
58. ea can be modified to allow for the most limited to most difficult degree of weight shifting To reposition the target zone hit lines at any time simply touch the desired line and re touch the screen where you want the line to be relocated Scoring is percentage based and equals net good hits total target hits If you cross the bound ary that counts against the good hit total All outside boundary hits are subtracted from the total amount of target hits This value equals the net good hits For example Enter 10 as the of target hits There were 4 times the cursor went outside the boundary 10 4 6 good hits Score 6 10 or 60 For weight shift training the time value always counts up NOTE wall hit is counted as one hit within the path to the target hit Weight Shift Training Time 00 00 Q Score 0 STATIC Skill Level Target zone hit Clear Tracing Press START to Begin Figure 7 4 The Weight Shift Training Screen To Access The Weight Shift Training Mode Position the support handles as per patient protocol Position the display height and tilt for patient comfort At the Main Menu touch lt Training gt The Training Menu screen should now be displayed pce SM de Touch Weight Shift gt The User Setup Information screen should now be displayed If this is a new patient and you want to save this training session after its completion you must enter the patient s name height and weight If you do not nee
59. ed by positioning the patient on a static force plate and then sam pling and recording patient movement The system employs a series of strain gauges to deter mine variation in the subject s resultant center of pressure COP The center of pressure is the patient s center of gravity projection on the platform resulting from sway angle and the patient height Data is sampled at the rate of 20Hz Each recorded sample consists of a X Y coordi nate What is displayed is the sway angle derived from the position of the COG from zero and the height of the patients COG taken as 55 times the patient height This data is recorded for later analysis and also displayed in real time on an LCD display observable by the patient The resultant movement results in a spaghetti plot as shown below This plot indicates patient movement from one sample to the next Essentially the database consists of an array of X Y coordinates defining the calculated COP The data can be interpreted as an ordered series of sequential vectors from point to point For example X0 YO X1 Y1 X2 Y2 APPENDIX A A 2 The Score is defined as the standard deviation of position over the length of the test The Standard deviation is interpreted to be the absolute vector length deviation from the mean vec tor end point Basically all vectors X Y coordinates are summed and divided by the number of samples to obtain a vector sum which represents the posi
60. ement Patient Name Exercise Date Time 2123 PST 09 03 2010 1 03 PM athlete single leg ASL 09 02 2010 10 26 AM athlete single leg ASL 09 02 2010 10 22 AM avril lange ASL 09 03 2010 2 44 PM fall risk FRT 09 02 2010 9 53 AM 3j PSTR 09 02 2010 2 25 PM limits of stab Los 09 01 2010 11 11 AM limits of stab Los 09 01 2010 11 08 AM age 06 00 Back Multiple Delete Multiple Export Figure 11 4 The Patient Management Screen View Test Results See Figure 11 4 To view the results of any test displayed simply touch the desired entry on the Patient Management screen to produce an on screen report Stored Postural Stability Test Results Actual STD Score Dev Overall Stability Index 1 9 2 23 Anterior Posterior Index 0 8 0 75 Medial Lateral Index 1 5 2 27 Time in Zone A 85 B 15 c O D 0 Time in Quadrant 1 30 u 27 m 19 IV 24 0060609 Back Repeat Progress Report Delete Figure 11 6 A single stored patient Postural Stability Test Record Lu SYSTEM UTILITIES Repeat recall a patient for a test or exercise session To repeat any saved test or exercise session touch lt Repeat gt on the on screen report The sys tem will return to the appropriate test or training Position Patient screen with the position val ues for foot and heel reflecting the selected session The selected name age and height of the selected patient will also be recorded with the new test or training session if you save at comple
61. en Training Postural Stability Weight Bearing Random Control D Select Custom Protocol Other Apps Limits of Stability 2 A listing of either Training or Testing protocols will appear Select desired protocol Training Custom Protocols Protocol 20s 12 5 tone 20s h 12 3 targs 20 secs 7 11 4 targs D 2 wg 08 9 q OU 7 17 THE TRAINING MODES 8 TESTING The Biodex Balance System SD allows clinicians to assess a patient s neuromuscular control in a closed chain multi plane test by quantifying the ability of the patient to maintain dynamic uni lateral or bilateral postural stability on either a static or unstable surface The degree of surface instability is controlled by the system s microprocessor based actuator The clinician selects the test duration stability level and protocol In a dynamic test once the session beings the patient s ability to control the platform angle is quantified as a variance from the locked level position as well as degrees of deflection over time A large variance may be indicative of poor neuromuscular response Further insight into specific neuromuscular activation patterns is realized with the quantification of anterior poste rior and medial lateral platform tilt Predictive Values and Comparative Bilateral Reports are available to chart the patient s performance Bilateral comparisons quickly document differences between each lower extremity S
62. en also allows the clinician to set an end by time value Touch lt OK gt after making changes to return to the Weight Bearing Training screen If desired shift the red Weight Bearing target zone by touching and dragging the appro priate red line to the desired Weight Bearing target Explain the training protocol to the patient and then press Start on the display to begin the training session The grid charts the patient s weight bearing performance though the course of the training session touch the Magnifying Glass to enlarge the screen if desired The Elapsed Time from the start of the session is shown at the top right of the dis play A running patient score is provided in the upper right corner NOTE If you have selected to enlarge the screen by touching the lt Magnifying Glass you must return to the normal viewing screen format to make amy changes To stop the training session at any time press lt Stop gt on the display The system will stop gathering data THE TRAINING MODES 7 14 14 15 When you are finished reviewing the Weight Bearing Training screen touch lt Print gt to print the screen or Save Results to save the training session numeric data only After printing or reviewing the screen press Start to immediately begin another training session using the same parameters or press Back to return to the Training Setup screen NOTE Scoring is the time spent within the targe
63. est Trials 1 Left Percent Actual Difference Score Overall 17 3 0 Anterior Posterior Index s Medial Lateral Index 1 LZ Anterior Left pr aN Right SAV Vp Lt Posterior Comments Clinician 9 2 Sample Postural Stability Bilateral Comparison Test Report 2gs REPORTS Limi f ili T R 1 Name Alan Heyen Height 65 73 Age 57 Foot Placement Protocol Platform Setting 8 Foot Angle 0 Test Trial Time 20 Heel Position Test Trials 1 Time to Complete Test 12 e c EE Direction Control Actual Overall 53 Forward Backward Right Left Forward Right Forward Left Backward Ri ght Backward Left tel RRREBE B RBRERE Comments Clinician 9 3 Limits of Stability Single Leg Test Report unilateral stance REPORTS 0 46 Name Simon Fletcher Date 10 20 2005 11 31 AM Height 65 73 Age 27 Eoot Placement Protocol Left Platform Setting 8 Foot Angle 5 Test Trial Time 20 Heel Position e4 Test Trials 3 Time to Complete Test 12 ao a Direction Control Actual Overall Forward Backward Right Left Forward Ri ght Forward Left Backward Ri ght Backward Left REBBREBER B BRRERE Comments Clinician 9 4 Limits of Stability Test Report bilateral stance 9 7 REPORTS Name Horace Clark Date 10 20 2005 11 35 AM Height 65 73 Age 28 Foot Placement rotocol Left Right Platform Sett
64. est challenges patients to move and control their center of gravity within their base of sup port During each test trial patients must shift their weight to move the cursor from the center target to a blinking target and back as quickly and with as little deviation as possible The same process is repeated for each of nine targets Targets on the screen blink in random order Three skill levels allow the targets to be grouped closer together or spread further apart If desired single leg LOS test may be performed but no bilateral comparison is provided This test is a good indicator of dynamic control within a normalized sway envelope Poor con trol inconsistencies or increased times suggests further assessment for lower extremity strength proprioception vestibular or visual deficiencies may be indicated The default setting for the LOS test is 75 LOS moderate still level References 1 Clark S Rose DJ Fujimoto K Generalizability of the Limits of Stability Test in The Evaluation of Dynamic Balance Among Older Adults Arch Phys Med Rehabilitation Vol 78 Oct 1997 Limits of Stability Testing Pattern Full Tem al a an Skill Lovel 3 3 3 Tracing 3 3 N i 39 23 o H Clear Tracing Press START to Release Platform o o Figure 8 6 The Limits of Stability Testing screen Limits of Stability Testing Options Rest Countdown 140 Limits of Stability Hold Time o Cancel Figure 8 7 The Limits of
65. ested that peripheral vision is more important for postural control and balance than central vision Shumway Cook amp Woollacott 2001 The visual system may provide inaccurate information to the nervous system For example a person sitting at a stoplight in a car may think she has started to move when the car next to her starts to move The visual system goes along with the movement of the neighboring car and tells the brain that both cars are moving The CNS mediates this sensory conflict by instructing the leg to slam on the brake to stop the car from moving forward As soon as the foot touches the brake the somatosensory and vestibular systems realize that the car is in fact not moving For a split second input from the visual system was given preference by the brain even though the information turned out to be inaccurate Visual input may also be inaccurate due to diseases or disorders that affect the visual system such as diabetic retinopathy cataracts macular degeneration injuries or stroke Vestibular Input The vestibular system is responsible for processing information about movement with respect to gravity specifically rotation acceleration deceleration and head stabilization during gait The vestibular system works in conjunction with the visual system to stabilize the eyes and maintain posture during walking vestibular ocular reflex Vestibular disorders cause a feeling of dizziness and unsteadiness Vestibular dys
66. etic environment RF emissions CISPR 11 The Balance System SD generates RF energy only for its internal functions Therefore its RF emission is very low and is not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 Class A The Balance System SD is suitable for use in all establishments other than domestic and those directly connected to the public low voltage power supply network supplying buildings used for domestic purposes Harmonic distortion Class A EN 61000 3 2 Voltage fluctuations Complies and flickerEN 61000 3 3 Immunity Manufacturer s declaration electromagnetic immunity The Balance System SD is intended for use in the electromagnetic environment specified below The customer or the user of the Balance System SD should assure that it is used in such an environment Immunity test IEC 60601 1 2 IEC 60601 1 2 Electromagnetic Test level Compliance level environment guidance Electrostatic discharge 6 kV contact Contact 6 kV Floor should be wood concrete or ceramic tiles If floor is covered with synthetic material the relative humidity should be at least 30 Electrical fast 2 kV for power lines Power 2 kV Mains power quality transients burst 1kV for Signal 1 kV should be that of a IEC 61000 4 4 input output lines typical commercial or hospital environment Surge 1 KV differential mode 1 KV diff mode Mains power quality IEC 61000 4 5 2 kV common mode 2 kV com mode
67. eypad displayed e To turn the cursor ON OFF touch Cursor to toggle between choices e To toggle bilateral comparison Yes or No touch Bilateral Comparison TESTING 8 4 14 15 16 17 18 19 20 Press Start to release the platform if not static and activate the Postural Stability Test screen With the patient ready to begin the test touch Collect Data The screen will provide a three second countdown before beginning the first of three test trials The display screen will show Total Trial Time Platform Setting and Stance to the left of the grid Trial Number and score are displayed to the right of the grid If desired at this point you can touch the Magnifying Glass to select the zoom feature You must however leave the zoom feature to make any changes NOTE To stop a test in progress at any time and return to the Postural Stability Testing screen with the platform locked touch Cancel or Stop When the first trial is finished the screen will display Trial 1 Complete the platform will return to the locked position and a 10 second rest countdown will begin for the second trial Touch Collect Data gt to begin the second test trial and continue in the same manner to complete trials two and three After completing the test a Test Complete message is displayed Touch lt Results gt to advance to the Postural Stability Test Results screen NOTE If you have se
68. f the easiest maze If the wall is hit 6 times the resulting score will be 22 28 78 Maze Control Training time 00 00 Score 0 STATIC Clear Tracing Press START to Begin Figure 7 5 The Maze Control Training screen To Access The Maze Control Mode 1 Position the support handles as per patient protocol 2 Position the display height and tilt for patient comfort 3 At the Main Menu touch Training The Training Menu screen should now be displayed 4 Touch Maze Control gt The User Setup Information screen should now be displayed If this is a new patient and you want to save this training session after its completion you must enter the patient s name height and weight If you do not need to save the training session touch lt Next gt and skip to step 8 THE TRAINING MODES 7 8 5 Touch the lt Keypad gt icon for Name and enter the patient s name Touch lt OK to return to the User Information screen 6 Touch the lt Keypad gt icon for Age and enter the patient s age Touch lt OK to return to the User Information screen 7 Touch the lt Keypad gt icon for Height and enter the patient s height Touch lt Next gt to advance to the Maze Control Training screen 8 Touch Skill Level gt to increase or decrease the number of targets displayed on the graph Three skill levels are available from which to choose Touch Skill Level gt until the desired target configuration is displa
69. form 12 vs one the more challenging the activity will become Ensure the patient uses the handrails at all times 5 1 APPLICATIONS A NOTE DE R F RENCE 1 Cette activit doit tre entreprise avec pr caution S assurer que le patient est capable de r aliser l activit 2 S assurer d une bonne stabilit bilat rale avant de commencer un travail sur la stabilit unilat rale 3 S assurer que le patient sait utiliser l appui correctement 4 S assurer que la stabilit bilat rale statique sur une seule jambe est ad quate avant de proc der la stabilit unilater rale 5 Plus le plateau est instable 8 quivaut un r glage plus stable le r glage 1 quivaut un niveau moins stable plus l activit est difficile r aliser S assurer que la patient utilise l appui tout moment APPLICATIONS 52 6 GETTING STARTED The Biodex Balance System software program is easy to master Simply follow the screen prompts as they lead you step by step through testing and training protocols or software utility options For each screen active option keys are highlighted in boldface type Touch the desired on screen key to make your selection Option choices progress logically based on the selections made There is no more on off button There is always power to the display The screen saver goes blank after a time out period System default is 5 minutes This can be adjusted in System Utilities See pag
70. function also affects the ability of the CNS to medi ate intersensory conflicts such as that in the example given above D3 APPENDIX D Somatosensory Input Somatosensory input consists of touch and proprioception Input from these two sensory sources provides critical feedback to the CNS regarding positioning in space body sway and changes in terrain The sensory input from touch and proprioception allows the muscles to make constant automatic adjustments to maintain balance and avoid falls In the example where the person in the stationary car slams on the brake only to realize through somatosensory input that her car has not moved the feeling that the car is moving when it is not is an example of a visual intersensory conflict the conflict is resolved quickly by pressing on the brake and feeling that the car has not moved Sensory Disorganization The loss or disruption of sensory input in the visual vestibular and or somatosensory systems can affect balance in a number of ways How balance is affected depends on several factors including the extent of the nervous system damage the number and extent of sensory losses and the availability of the other senses for compensation In many instances more than one sen sory system is impaired as in the case of a person with a peripheral neuropathy and visual impairment common with diabetes and stroke But just as an individual with impaired vision develops a keener sense of hearin
71. g a person with any sensory loss will attempt to compensate by using the unaffected or less affected senses to improve balance Sensory Loss The way balance is affected by loss of sensory input depends on the extent and nature of the sensory loss Recall that the senses most associated with balance are somatosensory touch and proprioception visual and vestibular Of these the somatosensory system plays the biggest role in balance so losses associated with peripheral neuropathies stroke and other neurologic disorders can have a profound effect on balance A person with sensory loss eg bilateral lower leg peripheral neuropathy who does not receive normal sensory input from the sensory receptors in the feet and ankles will attempt to compen sate by depending more on visual and vestibular input for balance If there is significant sensory loss in the feet a person will be unable to adjust easily to changes in the support surface during tasks such as walking on grass or uneven surfaces or even walking in shoes with soft soles A person with impaired vision from a stroke or cataracts will depend less on vision and more on touch and vestibular feedback for balance In this case choice of assistive device hand rail ings for touch and proper lighting are important A person with a visual impairment may per form well in a clinical setting but have difficulty with balance in more complex visual situations that demand rapid visual interpretation
72. gt to advance to the Postural Stability Testing screen At the Postural Stability Testing screen touch lt Stance gt to scroll through the three stance positions provided left right or both Touch lt Tracing gt to toggle tracing ON or OFF as desired Touch Clear Tracing gt to clear any tracing that remains from previous tests Touch More Options gt to advance to the Postural Stability Test Options screen if desired Here you can set the Test Trial Time enter initial and ending platform stability settings enter the number of trials enter the Rest Countdown or toggle bilateral comparison to Yes or No and enter the Rest Countdown You can also toggle the cursor ON OFF Touch OK to confirm your selections and return to the Postural Stability Testing screen e Use the lt A gt or lt W gt keys to set the total time in five second increments during the routine the system will count down from the time setting selected NOTE Total time must be set before you can set beginning and ending platform stability To set initial or ending platform stability static 12 is most stable 1 is least stable touch the appropriate key and then enter the setting from the keypad displayed Touch lt OK gt to return to the Postural Stability Testing Options screen and set the ending platform stability in the same manner e To set the number of trials or rest countdown touch the appropriate key and then enter the setting from the k
73. h all aspects of adjustment training and testing as well as patient history Be sure to adhere to the following clinical guidelines at all times when using this system NOTE Never allow a patient to use the Balance System while unsupervised CONSIDERATIONS CLINIQUES Avant d appliquer le syst me de stabilit un patient lire avec soin la pr sente notice Il faut se familiariser avec tous les aspects de r glage d entra neemnt et d examen ainsi qu avec le dossier du patient Respecter les consigues indiqu es ci dessous lors de l utilisation du syst me NOTA Ne jamais laisser un patient sans surveillance sur le syst me de stabilit GENERAL CLINICAL CONSIDERATIONS 1 Allusers should have a verbal understanding of the Balance System prior to stepping on the device 2 To ensure patient safety begin each session with the balance platform in the locked or static position NOTE The Balance System automatically places the platform in the locked position when the unit is turned ON or after a time period of three minutes when the system is not in use 3 Adjust support rail and biofeedback display for patient comfort and safety 4 When dealing with post operative patients ensure they possess adequate muscular control to stabilize the joint prior to placing them on the foot platform Inadequate muscular control could lead to increased joint translation 5 When patients are working with their eyes closed ensure that a clinic
74. hat occurred This diagnostic process may take a few minutes so call us when you have time to spare 2 After taking the information we will advise on the action we will take 3 Sometimes service personnel must consult with engineering and it may take time to get back to you Be sure to let the service representative know your schedule so that we can call at a convenient time 4 The return call may be from a person other than whom you first reported the problem to 5 After analyzing the problem we will decide if the unit must be returned to us for repair or replacement parts will be sent 6 If the unit must be returned it will be given a Return Materials Authorization Number R M A number by us Pack the system in the carton that it was originally shipped in or pack it safely and securely to avoid shipping damage It is the customer s responsibility for any damage that occurs during shipping 7 Non warranty non service contract charges for repair are as follows a Materials b Time c Shipping Charges Contact Information Biodex Medical Systems Inc 20 Ramsey Road Shirley New York 11967 4704 Tel 800 224 6339 Int 1 631 924 9000 Fax 631 924 8355 Email supportservices biodex com www biodex com BALANCE SYSTEM SD WARRANTY X 1 INTRODUCTION 12 1 High resolution color Auxiliary Serial and touch screen LCD display USB Printer Ports Adjustable height display to accommodate eacb patient Adj
75. he Fall Risk Defaults screen will now be displayed 2 Touch to highlight the predictive value you wish to adjust 3 Use the lt A gt or lt W gt arrows to increase or decrease the value displayed M CTSIB DEFAULT SETTINGS See Figure 11 3 At the m CTSIB Default Settings screen users can set which conditions of the CTSIB they want as defaults for testing as well as the ability to enter in or change the Sway Index Goals Default settings can be restored to factory defaults by touching Restore Defaults m CTSIB Defaults ALS 17 72 Choose Default Conditions __Sway Index Goal Eyes Open Firm Surface 0 48 Eyes Closed Firm Surface Visual Conflict Firm Surface SERE Eyes Open Foam Surface N N Eyes Closed Foam Surface A N Visual Conflict Foam Surface Restore Defaults c Cancel oK Figure 11 3 System m CTSIB Defaults Settings SYSTEM UTILITIES qc To Adjust the CTSIB Age Range 1 At the Configuration Screen touch lt m CTSIB Defaults gt The m CTSIB Defaults screen will now be displayed 2 Select Age Range 3 Select the Age Range you would like to adjust The From and To values in the range will appear on the screen 4 Select the value you would like to adjust Adjust the value using the lt A gt or lt V gt arrows or the key pad displayed 5 Press lt OK to save the adjustment s and return to the m CTSIB Age Range screen 6 Press lt OK gt from the m
76. he Predictive Values there maybe a balance problem Bilateral comparisons can be made to determine progress made dur ing rehabilitation on the Comparative Report see Figure 9 2 Anterior Posterior Stability Index Represents the variance of platform displacement in degrees from level for motion in the sagittal plane Medial Lateral Stability Index Represents the variance of platform displacement in degrees from level for motion in the frontal plane Standard Deviation The amount of variability in the statistical measure A low standard devia tion demonstrates that the range of values from which the mean was calculated were close together DATA 10 2 11 SYSTEM UTILITIES System Utilities allow users to access the System Configuration and Patient Management screens To access the System Utilities touch Utilities on the Main Menu The System Utilities screen should now be displayed From here you can select Configuration or Patient Management by touching the desired icon SYSTEM UTILITIES includes e CONFIGURATION e PATIENT MANAGEMENT e CUSTOM PROTOCOL LIST e PATIENT DATA STORAGE USAGE e PLATFORM SET UP e SOFTWARE AND HARDWARE INFORMATION e HOURS OF USE 09 09 2010 Utilities 4 44 59 PM Configuration Patient Management Custom Protocol List Patient Data Storage Usage Upper Display Module UDM Biodex SW PN 950 300 E617 Firmware Version 1 41 09 09 2010 Lock Platform PC104 Firmware 1 00
77. height Touch lt Next gt to advance to the Postural Stability Training screen 8 At the Postural Stability Training screen touch Place Target and then touch the screen location where you would like a target to be placed Repeat this process to place up to nine targets on the screen THE TRAINING MODES 7 2 10 11 12 13 14 15 16 To clear any misplaced or unwanted targets touch Clear Target Each time this key is pressed the most recent target added to the screen will be removed Touch More Options to advance to the Postural Stability Training Options screen if desired Here you can set the total time for the exercise enter initial and ending platform stability settings and turn tracing ON OFF Touch lt OK gt to confirm your selections and return to the Postural Stability Training Options screen or Cancel to return to the Postural Stability Training Options screen without making changes e Use the lt A gt or lt W gt keys to set the total time in 10 second increments during the routine the system will count down from the time setting selected NOTE Total time must be set before you can set beginning and ending platform stability e To set initial platform stability touch the appropriate key and then enter the setting from the keypad displayed static 12 is most stable 1 is least stable Touch lt OK to return to the Postural Stability Training Options screen and set the end
78. ialized receptors located in the sensory end organs in the eyes vestibular apparatus of the inner ear muscle spindles Golgi tendon organs and touch receptors in the skin Sensory input is transmitted to the spinal cord via afferent nerve fibers and then to the brain via spinal nerve tracts such as the spinothala mic tract pain and temperature and the dorsal column medial lemniscal tract fine touch mus cle and tendon position sense Sensory input provides a continuous flow of information to the CNS which in turn utilizes this incoming information to make decisions about movement The CNS sifts compares weighs stores and processes sensory input and uses this information to alter the force speed and range of a movement Vision Vision is a critical part of our balance system It allows us to identify objects and determine their movement and tells us where we are in relation to other objects object to object orientation When we use vision to gather information about the position of our body in the environment or to determine the position of one body part vis vis another then vision is providing proprio ceptive information to the CNS as well visual proprioception Vision works in conjunction with the vestibular system comparing information about velocity and rotation from the vestibular system with actual visual information The visual system is a combination of both central and peripheral vision although some research has sugg
79. ian is ready to assist in case of loss of balance or use the optional patient support stand 6 Since the entire lower extremity is required to work to stabilize the balance device ensure that supporting structures above and below the joint are adequately strengthened prior to beginning rehabilitation on this device 7 Foroptimal operation ensure the patient is standing in the center of the platform 8 Patients should progress from hands on to hands off the support handle This will ensure that new or unstable patients have an adequate understanding of the Balance System and will help protect the patient against sudden or unexpected movement of the platform 9 Position the display so that the patient can look straight at it This will help ensure good posture during the test or exercise session 10 There is a learning curve that must be considered when testing with this device Clinical research suggests three trials be performed prior to testing For dynamic balance testing the default settings are preselected with three trials per side This should assist with the learn ing curve and better average the data 4 1 CLINICAL CONSIDERATIONS CONSIDERATIONS CLINIQUES GENERALES 1 2 10 Tout patient doit comrendre les principles du syst me de stabilit avant de s y mettre D marrer toutes les s ances avec le platcau en position bloqu c NOTA Lors de la misc sous tension le syst me de stabilit se met au
80. ided in this manu al Electromagnetic compliance definition is provided in Appendix E e Reference Cleaning and Maintenance Chapter 13 A Operation for 115 230 VAC 50 60 Hz A Only use approved power supplies CAUTION To avoid risk of electric shock this equipment must only be connected to supply mains with protective earth ATTENTION Pour viter le risque de choc lectrique cet quipement doit uniquement tre con nect un approvisionnement conduites avec la terre protectrice VII IMPORTANT SAFETY INFORMATION A CAUTION The plug is considered the method of disconnecting the product from mains power Do not place the product in a position where the plug is not easily accessible A ATTENTION Le bouchon est consid r e comme la m thode de d connexion du produit d alimen tation Ne placez pas le produit dans une position o le bouchon n est pas facilement accessible A CAUTION The product is intended to remain in one location during operation The product is provided with wheels for relocation and should be used when performing this operation One per son can move the product A ATTENTION Le produit est voulu rester dans un emplacement pendant l op ration Le produit est fourni avec les roues pour la relocalisation et devrait tre utilis en ex cutant cette op ration Une personne peut d placer le produit IMPORTANT SAFETY INFORMATION VIII BALANCE SYSTEM SD WARRANTY 1 Instru
81. idered when working with patients in a fall prevention program 1 It is strongly recommended that the Biodex Unweighing System be used in conjunction with balance training testing NOTE The Biodex Unweighing System is intended to assist the patient who has balance deficits Clinicians should not rely on this device to prevent falls Since the Biodex Balance System allows up to 20 degrees of surface tilt begin with static or stability level 12 and progress as tolerated NOTE The static setting is most stable level one is least stable Levels 12 to 1 provide a full 20 degrees of surface tilt Patients with extreme weakness or atrophy especially of the lower extremity should be closely monitored CLINICAL CONSIDERATIONS 4 2 NOTE The ankle provides a critical source of sensory input controlling the degree of sway in elderly patients Repeat bouts of balance training where the joint is displaced nearly to its limits have been shown to increase muscle tone thus increasing muscle spindle sensitivity and enhancing the somatosensory response AUTRES CONSIDERTIONS POUR DES PROGRAMMES DE PREVENTION DE CHUTES En plus de ce qui pr c de les points voqu s ci dessous doivent tre tudi s dans le cadre d un travail avec des patients dans un programme de pre vention de chute 1 L utilisation du harnais de soutieu est recommend lors de l entra nement et de l valuation de la stabilit NOTA Le harnais ne
82. ing 4 Foot Angle 5 5 Test Trial Time 20 Heel Position e4 el7 Test Trials 3 Actual STD Normal Score Overall Stability Index 2 2 Anterior Posterior Index 1 2 Medial Lateral Index 1 0 3 0 3 5 Your Score Overall Stability Index BM Anterlor Posterior Index Il Medial Lateral Index Anterior Left Right Posterior Comnents Clinician 9 5 Athlete Single Leg Stability Test Report REPORTS 9 8 Fall Risk Test Results Date 05 04 2012 3 05 PM FOOT PLACEMENT Left Right PROTOCOL Name STEVE SMITH Foot Angle 10 10 Platform Setting 12 8 Height 59 65 Heel Position D6 D16 Test Trial Time 20 secs Age 78 Test Trials 3 Cursor ON Device Balance SD Actual Score Standard Deviation Overall Stability Index 3 60 2 54 Your score compared to age group of healthy people 0 0 0 5 1 0 1 5 2 0 2 5 3 0 3 5 4 0 4 5 5 0 Anterior ao Il I D C dL s o Left LE Right uml rd m Il IV es md Posterior Comments Clinician 9 6 Fall Risk Test Report Comparison to normative data can be made for population specific tests using the Fall Screening and Athlete Single Leg Stability protocols 9 9 REPORTS BIODEX Clinical Test of Sensory Integration of Balance Date 10 20 2011 7 52 AM FOOT PLACEMENT Left Right PROTOCOL Name JOSEPHINE JONES BIODEX Foot Angle 10 10 Conditions Modified Height 59 65
83. ing platform stability in the same manner e To turn tracing ON OFF touch lt Tracing gt to toggle between choices At the Postural Stability Training screen touch the lt A gt or lt W gt keys to select the desired platform stability if not already selected static 12 is most stable 1 is least stable Explain the training protocol to the patient and then press lt Start gt on the display to begin the training session The Stability Training grid on the screen charts the patient s stability per formance through the course of the training session touch the Magnifying Glass to enlarge the screen if desired The Elapsed Time from the start of the training session is shown at the top right of the display while the stability level is illustrated by a bar graph in the upper right hand corner Note that the stability level of the foot platform can be changed at any time dur ing the exercise session NOTE If you have selected to enlarge the screen by touching the Magnifying Glass you must return to the normal viewing screen format to make any changes NOTE As the patient moves the platform during the training session a tracing feature records the route of the cursor on the grid This feature can be used to visually illustrate a patient s position ing throughout the routine or as a target i e asking the patient to trace a letter square circle etc At any time during the training session the tracing can be erased by
84. ing screen format to make any changes At any time during the training session the tracing can be erased by pressing Clear Tracing gt To stop the training session at any time press lt Stop gt on the display The system will stop gathering data and the platform will advance to the locked position When you are finished reviewing the Weight Shift Training screen touch Print to print the screen or Save Results to save the training session numeric data only After printing or reviewing the screen press Start to immediately begin another training session using the same parameters or press Back to return to the Training Setup screen 77 THE TRAINING MODES MAZE CONTROL TRAINING See Figure 7 5 This mode allows the patient to follow a reproducible pattern of movement throughout a maze in both static and dynamic environments Three skill levels allow the maze to be modified to create a simple or more difficult environment for the patient to navigate through Change the platform from static mode to dynamic mode to facilitate progression Time counts up or down as set Scoring is percentage based on the net good hits total target hits If the cursor hits the boundary that hit is subtracted from the total possible amount of good hits e Easiest maze has 28 total targets 14 in each direction e Moderate has 36 targets 18 in each direction e Most difficult has 72 targets 36 in each direction In the case o
85. ith the patient ready to begin the test touch Collect Data gt The screen will provide a three second countdown before beginning the first of three test trials The display screen will show Test Trial Time Platform Setting and Stance to the left of the grid Trial Number and score are displayed to the right of the grid NOTE To stop a test in progress at any time and return to the Athlete Single Leg Stability Testing screen with the platform locked touch Cancel or Stop 16 When the first trial is finished the screen will display Trial 1 Complete the platform will return to the locked position and a 10 second rest countdown will begin for the second trial Touch Collect Data gt to begin the second test trial and continue in the same manner to complete trials two and three 17 After completing the test a Test Complete message is displayed Touch Results to advance to the Athlete Single Leg Stability Test Results screen 18 At the Athlete Single Leg Stability Test Results screen touch Print to automatically gener ate a printed report if desired 19 To save the test data touch Save Results and then touch OK in response to the Save Results for later reporting or export prompt The system will display Save Results Completed after the results are saved 20 To return to the Opening Menu from the Athlete Single Leg Stability Test Results screen touch lt Home gt TEST PROTOCOL FOR ATHLETE SINGLE LEG
86. lected Bilateral Test the system will begin by testing the initial side as set up above After the third trial on the initial side is finished touch Test Other Leg to continue The system automatically selects the opposite side and then allows the user to proceed from the Position Patient screen Repeat steps 8 17 to test the opposite side At the Postural Stability Test Results screen touch Print to automatically generate a print ed report if desired If you have performed a Bilateral Test the Test Results screen and report will provide a bilateral comparison To save the test data touch Save Results and then touch lt OK gt in response to the Save Results for later reporting or export prompt The system will display Save Results Completed after the results are saved To return to the Opening Menu from the Postural Stability Test Results screen touch lt Home gt 8 5 TESTING SUGGESTED TEST PROTOCOL FOR GENERAL POSTURAL STABILITY BALANCE TESTING The test protocol most commonly used with the Biodex Balance System is a Dynamic Balance test as follows Test Duration 20 seconds Stability Level 8 Stance Two Leg Reliability studies have been done for this protocol In addition much of the research being pre sented is at these levels Three or four trial repetitions should be performed prior to testing at each level Again this is supported by research The patient s performance is noted as a stabili
87. lity Results report TESTING PERFORMING AN ATHLETE SINGLE LEG STABILITY TEST See Figures 8 10 8 12 2 10 11 12 13 Position support handles as per patient protocol Position display height and tilt for patient comfort At the Main Menu touch Testing The Testing Menu screen should now be displayed Touch Athlete Single Leg Stability gt The User Setup Information screen should now be displayed Touch the lt Keypad gt icon for Name and enter the patient s name Touch lt OK to return to the User Setup Information screen Touch the Keypad icon for Age and then enter the patient s age Touch lt OK gt to return to the User Setup Information screen Touch the appropriate lt Height gt key to highlight the patient height range setting desired Touch lt Next gt to advance to the Patient Position screen Position the patient on the system and explain the test protocol Press Start on the display to activate the cursor and have the patient move the cursor to the center point on the grid Touch Record to bring up the Position Patient Entry screen Using the keypads enter the patient s left foot left heel right foot and right heel positions using the midline of the foot and the platform grid as reference points Touch lt Next gt to advance to the Athlete Single Leg Stability Testing screen At the Athlete Single Leg Stability Testing screen touch lt Stance gt to toggle be
88. ll 20 degrees of deflection from level in any direction For patient centering prior to testing the foot platform deflection is limited to less than five degrees Overall Stability Index SI Represents the variance of foot platform displacement in degrees from level in all motions during a test A high number is indicative of a lot of movement during a test with static measures it is the angular excursion of the patient s center of gravity Use as a starting point for a perfectly balanced state COB x 0 COB y 0 COB is Center of Balance 0 X 0 Y DI Ge number of samples Anterior Posterior AP Stability Index Represents the variance of foot platform displacement in degrees from level for motion in the sagittal plane 5 0 Yy Dly number of samples 9 1 REPORTS Medial Lateral M L Stability Index Represents the variance of foot platform displacement in degrees from level for motion in the frontal plane 0 X Dix number of samples Mean Deflection Average position for the patient in all motions throughout the test Mean Deflection gt Xn Yn n Xn Yn Xn Yn position vector magnitude A P Mean Deflection Average position of side to side motion for the patient throughout the test Y Yn n of samples A P Mean Deflection RE E Yn n th sample MIL Mean Deflection Average position for the patient in the frontal plane throughout the test Y Xn n
89. ment ICC 60601 2 EMC Standard PRODUCT CERTIFICATIONS Vi IMPORTANT SAFETY INFORMATION A CAUTION Federal Law restricts this device to sale by or on the order of a medical practitioner When prescribed for therapeutic purpose a physician should clearly define the parameters of use i e total work maximum heart rate etc to reduce the risk of patient injury A ATTENTION La Loi F d rale restreint cet artifice la vente par ou sur l ordre d un praticien m dical Quand prescrit pour le but th rapeutique un docteur devrait clairement d finir les param tres d utilisation c est dire travail total taux maximum du c ur etc pour r duire le risque de blessure patiente e Follow the assembly and installation instructions document p Before using this device read the entire operation manual carefully Failure to read the manual may result in user error or inaccurate data Be sure to save all provided docu ments for future reference Make certain to understand all warning and caution labels as explained in the Before Proceeding section of this manual e The Balance System SD should be used only as specified in the operation manual N The Balance System SD is designed for use in a patient environment e See Chapter 2 for Balance System SD specifications e This medical electrical equipment requires special precautions regarding EMC and must be installed and placed into service according to EMC information prov
90. mentation A This equipment and its accessories are warranted by BIODEX MEDICAL SYSTEMS INC against defects in materials and workmanship for a period of two years from the date of ship ment from BIODEX MEDICAL SYSTEMS INC During the warranty period BIODEX MED ICAL SYSTEMS INC will in its sole discretion repair recalibrate or replace the equipment found to have such defect at no charge to the customer EXCEPT AS STATED ABOVE THERE ARE NO WARRANTIES EXPRESSED OR IMPLIED INCLUDING WITHOUT LIMITATION WARRANTIES OR MERCHANTABILITY OR FITNESS FOR USE BIODEX DOES NOT ASSUME LIABILITY FOR INCIDENTAL CONSEQUENTIAL OR INDIRECT DAMAGES INCLUDING LOSS OF USE SALES PROFITS OR BUSINESS INTERRUPTION B This warranty does not apply if the product as determined by BIODEX MEDICAL SYS TEMS INC is defective due to abuse misuse modification or service performed by other than a BIODEX MEDICAL SYSTEMS INC authorized repair and calibration facility Misuse and abuse include but are not limited to subjecting limits and allowing the equipment to become contaminated by radioactive materials C In order to obtain warranty repair service the equipment or system component must be returned freight pre paid to one of our facilities The Return Materials Authorization number R M A should be included along with a statement of the problem Equipment or system component will be returned transportation prepaid 2 Calibration A Instruments are
91. n 4 Eyes Open foam surface 38 71 Condition 5 Eyes Closed foam surface 1 07 2 22 Condition 6 Visual conflict foam surface 84 1 47 C 1 APPENDIX C APPENDIX D BALANCE OVERVIEW Maintaining postural balance involves complex coordination and integration of multiple sensory motor and biomechanical components as graphically represented below Balance is a motor skill most people take for granted An individual senses body position in relation to gravity and envi ronmental surroundings by combining vestibular visual and proprioceptive somatosensory inputs 1 Body position and smooth functional movement patterns result from these coordinated actions along with integration of graded ankle knee and hip movements along the kinetic chain 2 A person s ability to maintain Balance becomes compromised when one action does not func tion accordingly and or equilibrium becomes altered A variety of consequences can occur due to poor balance therefore clinicians need to address each component in order to prevent injury re injury or further trauma The Biodex BioSway provides valuable objective assessment of neu romuscular control and somatosensory input important to balance MOVEMENT STRATEGIES FOR BALANCE SENSORY ORGANIZATION AGE RELATED CHANGES IN BALANCE AND CTSIB TEST RESULT INTERPRETATION MOVEMENT STRATEGIES FOR BALANCE Robertson According to the Systems Approach to motor control the nervous system uses preprogrammed
92. nd 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 Use of accessories transducers and cables other than those specified with the ex ception of acces sories transducers and cables sold by the manufacturer of this equipment as replacement parts for internal and external components may result in increased emissions or decreased immunity of the equipment The Balance System SD should not be used adjacent to or stacked with other equipment If the Balance System SD is used while positioned adjacent to other equipment it should be observed to verify normal operation in the configuration in which it will be used List of Cable Accessories The list in Table 1 2 includes all accessory cables supplied with the Balance System SD for which the manufacturer of this equipment claims compliance to EN 60601 1 2 when used with the Balance System SD Cable Description Part No Cable Length USB Printer Cable Biodex f C12086 15ft Table 1 2 Balance System SD cables p APPENDIX E Declaration of Conformity Emissions Manufacturer s declaration electromagnetic emissions The Balance System SD is intended for use in the electromagnetic environment specified below The customer or the user of the Balance System SD should assure that it is used in such an environment Emission test Compliance Electromagn
93. ng that remains on the screen from a previous exercise session Touch More Options to advance to the Random Control Training Options screen if desired Here you can set the total time for the exercise enter initial and ending platform stability settings and turn tracing ON OFF Touch lt OK gt to confirm your selections and return to the Random Control Training Options screen or Cancel to return to the Random Control Training Options screen without making changes e Use the lt A gt or lt W gt keys to set the total time in 10 second increments during the routine the system will count down from the time setting selected NOTE Total time must be set before you can set beginning and ending platform stability e To set initial platform stability touch the appropriate key and then enter the setting from the keypad displayed static 12 is most stable 1 is least stable Touch lt OK gt to return to the Random Control Training Options screen and set the ending platform stability in the same manner e To turn tracing ON OFF touch lt Tracing gt to toggle between choices At the Random Control Training screen touch the lt A gt or lt W gt keys to select the desired platform stability if not already selected static 12 is most stable 1 is least stable Explain the training protocol to the patient and then press lt Start gt on the display to begin the training session The Stability Training grid on the screen charts the pa
94. njury An easy to follow touch screen format makes the system simple to learn and operate leading the user step by step through testing protocols and training modes All test results and training ses sions are documented on easy to read 8 5 x 11 reports which can be placed into the patient s file Comparisons to normative data can be made for population specific tests using the Fall Screening Athletic Single Leg Limits of Stability and CTSIB protocols INTRODUCTION l 2 2 SYSTEM SPECIFICATIONS Dimensions Base 30 w x 44 depth x 8 h 76 x 112 x 20 cm Platform 21 5 dia 55 cm Display Height Adjustable from 53 to 68 h above platform 135 x 173 cm 76 h 193 cm maximum from floor Support Rails Adjustable from 25 to 36 5 above platform 64 to 93 cm Rails can swing away from platform when not in use Platform Tilt 20 degrees from horizontal in all directions Stability Levels Twelve levels plus locked for static measurements Game Port Simulates joystick output suitable for PC compatible game port Display Specifications Display Size and Type 12 1 30 7 cm color touch screen Display resolution 800 x 600 Operating System Windows CE 6 0 R3 Printing PCL printing via USB port see list of compatible printers Memory 256 MB Audio Audio out with standard stereo line jack Video Out Display supports simultaneous analog up to 800 x 600 resolution User Interface and Device Capabilities USB ports F
95. ort 1 Touch Utilities on the Main Menu The System Utilities screen should now be displayed 2 Touch Patient Management and enter code 781 to advance to the Patient Management screen 3 Touch the desired patient test and then touch Progress Report Note that the report will be limited to the specific test type selected 4 Up to ten test records can be displayed on the screen Scroll right or left to see additional tests 5 Touch Print to print the Progress Report 9 1 REPORTS CTSIB Report Date Range Patient Name 08 05 2011 To 10 05 2011 alex smith y way Index Dash Line Mean 25D 2 75 9 00 0 05 98 12 08 16 08 22 08 31 10 05 Close Foam Open Foam Close Firm Open Fam o o Figure 9 9 Progress Report graphs overall sway index scores for each test date Recall patients from the database to repeat tests or rehab sessions Prior foot position is displayed for standardization REPORTS 9 2 10 DATA ASSESSING LIMITS OF STABILITY WITH THE BIODEX BALANCE SYSTEM The Limits of Stability LOS for standing balance has been defined as the maximum angle a body can achieve from vertical without losing one s balance Once the LOS is exceeded a fall stumble or step will ensue LOS in normal adults is eight degrees anterior four degrees posteri or and 16 degrees in the lateral direction In the static mode the patient s movements are calculated as the average amount of angular dis placemen
96. otocol 2 Position the display height and tilt for patient comfort 3 Atthe Main Menu touch Training The Training Menu screen should now be displayed 4 Touch Random Control gt The User Setup Information screen should now be displayed If this is a new patient and you want to save this training session after its completion you must enter the patient s name height and weight If you do not need to save the training session touch lt Next gt and skip to step 8 5 Touch the lt Keypad gt icon for Name and enter the patient s name Touch lt OK to return to the User Information screen 6 Touch the lt Keypad gt icon for Age and enter the patient s age Touch lt OK to return to the User Information screen 7 Touch the lt Keypad gt icon for Height and enter the patient s height Touch lt Next gt to advance to the Random Control Training screen THE TRAINING MODES 10 11 12 13 14 15 16 17 At the Random Control Training screen the target circle should be flashing in the center of the stability grid Touch Circle Speed gt to toggle though the three target circle speeds until the target circle flashes at the desired speed Touch Skill Level gt to enlarge or decrease the target circle size Three skill levels are avail able from which to choose Touch Skill Level gt until the desired target size is displayed If desired touch Clear Tracing gt to remove any traci
97. our 1 1 host ports to support Mass Storage Device USB Thumb drive Keyboard Mouse wired and wireless to allow for remote control operation Plus 1 Remote CRT connector 1 Serial communication port Operating Temperature Range 59 F to 86 F 15 C to 30 C Operating Humidity Range 30 to 75 Transport Storage Temperature Range 4 F to 140 F 20 C to 60 C Transport Storage Humidity Range 20 to 80 non condensing Printer HP DeskJet Printer Stand 24 x 24 61 x 61 cm Patient Capacity Up to 400 Ib 136 kg Weight 196 Ib 89 kg Power 115 VAC 50 60 Hz 15 amp line or 230 VAC 50 60 Hz 15 amp line Power Rating 350 watts Certification ETL listed to UL 60601 1 and CAN CSA C22 2 No 601 1 M90 CE conformity to EN 60601 1 EMC compliance to EN 60601 1 2 Warranty Two years parts one year labor 2 SYSTEM SPECIFICATIONS Compatible Printers PCL printers specifically HP H470 HP 6000 HP 6940 HP 6940dt HP 6988 HP 9800 HP K5400 HP D5360 HP 5650 HP 5550 COMPATIBLE POINTING DEVICES Manufacturer Model Device Type Logitech M500 Mouse Seal Shield SSMSV5 Mouse Targus AMUS9US Mouse Razer Naga RZ01 0028 Mouse Microsoft 1049 Mouse Belkin F5L017 USB BLK Mouse Toshiba PA3571U 1ETB Mouse Microsoft 1422 Mouse Targus AMU75US Mouse Microsoft 1056 1051 Mouse Logitech V220 Mouse HP WX414AA Mouse Dynex DX PWLMSE Mouse Toshiba PA3651U 1ETC Mouse Logitech G500 910 001259 Mou
98. peat of a training or test session The print screen function will allow the user to generate a printout of training results Training results can also be saved and recalled for later use by touching the lt Save gt icon on the results screen following any training session A patient name is required to save the results If no pre existing name is available the name entry screen will be displayed Fill out the patient information and touch lt Save gt to record the training result numeric values along with patient foot position on the platform To recall a patient and repeat an exercise session select the desired patient from the Patient Management screen see chapter 11 System Utilities and touch Repeat The Position Patient screen with previous values is presented so the patient can be easily repositioned exactly as in the previous training session Training mode formats include postural stability limits of stability weight shift maze control random control and percent weight bearing training as described in the following sections Training Postural Stability Weight Shift Weight Bearing Limits of Stability Maze Control Random Control Back Select Custom Protocol Other Apps Figure 7 1 The Training Menu screen provides access to the Postural Stability Limits of Stability Weight Shift Maze Control Weight Bearing and Random Control training modes 71 THE TRAINING MODES POSTURAL STABILITY T
99. point on the grid 9 Touch Record to bring up the Position Patient Entry screen Using the keypads enter the patient s left foot left heel right foot and right heel positions using the midline of the foot and the platform grid as reference points Touch lt Next gt to advance to the Fall Risk Testing screen 10 At the Fall Risk Testing screen touch lt Tracing gt to toggle tracing ON or OFF as desired 11 Touch Clear Tracing gt to clear any tracing that remains from previous tests 8 15 TESTING 12 13 14 15 16 17 18 19 Touch More Options to advance to the Fall Risk Test Options screen if desired Here you can set the Test Trial Time enter the number of trials and enter the Rest Countdown You can also toggle the cursor ON OFF Touch lt OK gt to confirm your selections and return to the Fall Risk Testing screen e Use the lt A gt or lt W gt keys to set the Test Trial time in five second increments during the routine the system will count down from the time setting selected e To turn the cursor ON OFF touch Cursor to toggle between choices e To set the number of trials or rest countdown touch the appropriate key and then enter the setting from the keypad displayed Press Start to release the platform if not static and activate the Fall Risk Test screen With the patient ready to begin the test touch Collect Data The screen will provide a three second
100. present the four quarters of the Test Grid in the X and Y axis as follows For the Both Feet protocol e Quadrant 3 left posterior e Quadrant 4 right posterior For the Single Foot protocol e Quadrant 1 lateral anterior e Quadrant 2 medial anterior e Quadrant 3 medial posterior e Quadrant 4 lateral posterior Test Grid Provides a visual representation of Time Spent in Zone Quadrant View is orientated as if patient were looking down at foot platform while facing the display module Anterior Posterior and Medial Lateral Deflection Graphs Provides a visual representation of A P and M L deflection during the test View is oriented as if foot platform were positioned at eye level on a horizontal plane X axis time and stability level 9 3 REPORTS SAMPLE BALANCE REPORTS See Figures 9 1 9 8 Name Anne Ewell Date 10 20 2005 11 57 AM Height 59 65 Age 29 Foot Placement Protocol Platform Setting 12 7 Foot Angle Test Trial Time 20 Heel Position Test Trials 1 STD Overall Anterior Posterior Index Medial Lateral Index Time in Zone Time in Quadrant Anterior Left Right Posterior Comments Clinician 9 1 Sample Postural Stability Single Leg Test Report REPORTS 94 P ili T Results Name Cindy Speer Date 11 45 AM Height 59 65 Age 39 Foot Placement rotocol Platform Setting 8 Foot Angle Q 0 Test Trial Time 20 Heel Position dll T
101. pressing Clear Tracing gt To stop the training session at any time press lt Stop gt on the display The system will stop gathering data and the platform will advance to the locked position When you are finished reviewing the training screen touch Print to print the screen or Save Results to save the training session numeric data only After printing or reviewing the screen press lt Start gt to immediately begin another training session using the same parameters or press lt Back gt to return to the Training Setup screen 73 THE TRAINING MODES LIMITS OF STABILITY LOS TRAINING ROUTINE See Figure 7 3 The Limits of Stability Training screen is designed to challenge the user to move through a movement pattern consistent with the sway envelope The sway envelope is that area a person can move their COG within their base of support It is approximated from vertical as 8 degrees to one side 8 degrees to the other total of 16 degrees of sway and 8 degrees forward and 4 degrees back 12 degrees total Limits of Stability training and testing are based on challenging the patient within this sway envelope Testing is usually done at 7576 LOS which is the moder ate skill level Easy skill level is 50 and hard skill level is 100 of the sway envelop Scoring percentage based and reflects the directional accuracy of the movement to the blinking targets see Appendix B 1 time counts up Limits of Stability Tr
102. raining The Training Menu screen should now be displayed Touch lt Weight Bearing The User Setup Information screen should now be displayed If this is a new patient and you want to save this training session after its completion you must enter the patient s name height and weight If you do not need to save the training session touch lt Next gt and skip to step 8 Touch the Keypad icon for Name and enter the patient s name Touch lt OK gt to return to the User Setup Information screen Touch the lt Keypad gt icon for Age and enter the patient s age Touch lt OK to the return to the User Setup Information screen Touch the lt Keypad gt icon for Height and enter the patient s height Touch lt Next gt to advance to the Position Patient screen Position the patient on the system and explain the training protocol Press Start on the display to activate the cursor and have the patient move the cursor to the center point on the grid Touch Record to bring up the Position Patient Entry screen Using the keypads enter the patient s left foot left heel right foot and right heel positions using the midline of the foot and the platform grid as reference points Touch lt Next gt to advance to the Weight Bearing Training screen The Weight Bearing Training screen displays a Medial Lateral Anterior Posterior grid If you would prefer a Medial Lateral only grid touch More Options The More Options scre
103. raph A run ning patient score is also provided in the upper right corner Note that the stability level of the foot platform can be changed at any time during the exercise session NOTE If you have selected to enlarge the screen by touching the lt Magnifying Glass gt you must return to the normal viewing screen format to make any changes At any time during the training session the tracing can be erased by pressing lt Clear Tracing gt To stop the training session at any time press lt Stop gt on the display The system will stop gathering data and the platform will advance to the locked position When you are finished reviewing the training screen touch lt Print gt to print the screen or lt Save Results gt to save the training session numeric data only After printing or reviewing the screen press lt Start gt to immediately begin another training session using the same parameters or press lt Back gt to return to the Training Setup screen THE TRAINING MODES WEIGHT SHIFT TRAINING See Figure 7 4 This training mode allows for exercise in the most basic of activities weight shifting The patient has the ability to shift weight in medial lateral anterior posterior and diagonal planes This can be done with both static and dynamic settings During this training routine the target zone defined by two parallel lines can be rotated to any of three positions while the amount of excur sion within the target ar
104. red 3 months later on 27 of the original 100 subjects This third test was to negate any learning effect in the initial test retest given they were done consecutively with less than 2 weeks between trials Descriptive Statistics N Minimum Maximum Mean Std Deviation age 100 17 00 72 00 45 4400 10 80621 gender 0 Height meters 101 1 45 2 00 1 7263 11410 Waist CM 59 26 00 44 00 34 4576 4 01000 bmi 101 12 50 44 60 27 3748 5 50826 Valid N listwise 0 Reliability The resultant ICC is 81 which is considered acceptable Intraclass Correlation Coefficient Intraclass Correlation 95 Confidence Interval F Test with True Value 0 Lower Bound Upper Bound Value df1 df2 Sig Lower Bound Single Measures 668 573 745 5 024 161 0 161 000 Average Measures 801 729 854 5 024 161 0 161 000 Two way mixed effects model where people effects are random and measures effects are fixed a Type C intraclass correlation coefficients using a consistency definition the between measure variance is excluded from the denominator variance b The estimator is the same whether the interaction effect is present or not c This estimate is computed assuming the interaction effect is absent because it is not estimable otherwise CTSIB Normative Sway Index ranges are Condition 1 Eyes Open firm surface 21 48 Condition 2 Eyes closed firm surface 48 99 Condition 3 Visual conflict firm surface 46 88 Conditio
105. s SOUS TENSION En pareille circonstance user de pr cautions extr mes dans la maniplation du syst me F APPENDIX F APPENDIX G REFERENCES Biblography available at www biodex com balance AKBARI M et al BALANCE PROBLEMS AFTER UNILATERAL LATERAL ANKLE SPRAINS J of Rehabilitation Research amp Development JRRD Vol 43 No 7 819 824 Nov Dec 2006 Biodex 91 159 ALLET L et al THE GAIT AND BALANCE OF PATIENTS WITH DIABETES CAN BE IMPROVED A RANDOMISED CONTROLLED TRIAL Diabetologia 2010 Vol 53 458 466 Biodex 4192 292 ARNOLD BL et al NORMAL STABILITY PATTERNS AND RELATIONSHIP AS ASSESSED WITH THE BIODEX BALANCE SYSTEM J of Athletic Training Vol 32 2 S 25 April June 1997 Biodex 93 268 EXAMINATION OF BALANCE MEASURES PRODUCED BY THE BIODEX STABILITY SYSTEM J of Athletic Training Vol 33 4 323 27 Dec 1998 Biodex 93 287 AYDOG E et al EVALUATION OF DYNAMIC POSTURAL BALANCE USING THE BIODEX STABILITY SYSTEM IN RHEUMATOID ARTHRITIS PATIENTS Abstract only Clin Rheumatol 2005 Oct 25 1 6 Biodex 92 286 DYNAMIC POSTURAL BALANCE IN ANKYLOSING SPONDYLITIS PATIENTS Abstract only Rheumatology Oxford 2005 Nov 8 Biodex 93 105 BALLARD T PRODUCT PROFILE THE BIODEX BALANCE SYSTEM Biodex Medical Systems Biodex 91 111 BALDWIN S et al RELIABILITY OF DYNAMIC BILATERAL POSTURAL STABILITY ON THE BIODEX STABILITY SYSTEM IN OLDER ADULTS Med Sci Sports Exer 2004
106. s of stability is occurring leading to falls Sensorimotor Adaptation The nervous system has a powerful ability to compensate for actual or perceived disabilities Once an injury has occurred the nervous system immediately goes to work attempting to com pensate for neurologic changes weakness and loss of function But the brain doesn t always choose the best or even a good compensation it chooses the fastest and most efficient in an attempt to continue functioning One of the immediate goals of therapy is to help the nervous system develop strategies and compensations that minimize musculoskeletal damage and maxi mize function AGE RELATED CHANGES IN BALANCE Many changes in balance relate to normal aging Some changes i e slowed gait decrease in lower extremity strength decreased ROM can be easily addressed with a daily exercise pro gram Other changes i e declining visual ability including loss of visual acuity declining visu al fields light dark adaptation increased sensitivity to glare loss of peripheral vision and depth perception are more complex and may require assessment by another healthcare professional such as an optometrist or ophthalmologist Age related changes in balance are the result of changes in every system in our bodies Neurologic changes include slowed response to losses of balance decreased righting responses and abnormal sensory selection or weighting i e overuse of vision or underuse of proprio
107. se BTC M859C Mouse Logitech M BJ79 Mouse Dell MOASBO Mouse Dell M UK DEL3 Mouse Manhattan 176569 Mouse COMPATIBLE KEYBOARDY Manufacturer Model Device Type Mini Keyboard ACK 5010U USB Keyboard Adesso AKB 210 Keyboard Adesso WKB 4000US Keyboard Adesso ACK 540UB Keyboard Adesso AKB 110B Keyboard Printers and other devices are subject to market availability Please check with Biodex customer service if questions arise Authorized European Community Representative e rl Emergo Europe Molenstraat 15 2513 BH The Hague The Netherlands SYSTEM SPECIFICATIONS 2 2 3 ASSEMBLY amp INSTALLATION The Biodex Balance System SD is shipped in a single carton Except for the printer which the user must install as explained below the entire system is factory assembled and ready to operate If desired the system can be configured for PC computer compatibility allowing the foot plate to be used like a joystick for interactive video game use Joystick options are discussed in the System Utilities chapter PRINTER INSTALLATION See Figures 3 1 and 3 2 CAUTION It may be necessary to have the help of another person to steady the printer during the following procedure ATTENTION il peut tre n cessaire d avoir l aide d une autre personne pour stabiliser l impri A mante au cours de la proc dure suivante 1 Refer to the supplied printer manual to unpack the printer and ensure that it has not been damaged by shipping
108. selected field is highlighted 3 Use the lt A gt or lt W gt arrows to increase or decrease the value displayed for the highlighted parameter 4 Repeatsteps 2 and 3 until you have adjusted all the parameters you wish to correct 5 Touch lt OK gt to confirm your changes and return to the Configuration screen Touch Cancel to return to the Configuration screen without making any changes FALL RISK DEFAULTS See Figure 11 2 At the Fall Risk Default Settings screen users can set the default Fall Risk Platform settings adjust Predictive Values or return these parameters to their original factory set default values Fall Risk Defaults Initial Ending Fall Risk Platform Setting 12 L3 Predictive Values Age Range Index 8 17 35 YRS 0 70 r 2 10 a 36 53 YRS Te 3 10 to 3 70 To sE 8555 72 89 YRS Restore Defaults c Cancel OK Figure 11 2 System Fall Risk Defaults Settings 11 3 SYSTEM UTILITIES To Adjust Fall Risk Platform Setting 1 At the Configuration Screen touch Fall Risk Defaults gt The Fall Risk Defaults screen will appear 2 Touch the Fall Risk Platform Setting you would like to adjust Initial or Ending An adjustment selection screen will appear 3 Enter the desired platform setting via the key pad displayed 4 Touch lt OK to return to the Fall Risk Defaults screen To Adjust Predictive Values 1 At the Configuration Screen touch lt Fall Risk Defaults gt T
109. sert qu aider le patient atteindre le d ficit de stabilit Le harnais seul ne peut pas pr venir des chutes Puisque le sys me de stabilit permet une inclinaison de 20 d marrer avec une stabilit 8 et avancer en fonction de la tol rance rencontr e NOTA Le niveau 8 est le niveau le plus stable et le niveau l est le niveau le moins stable les deux r glages permettent 20 d inclinaison Des patients particuli rement faibles ou atrophi es surtout dans les extr mit s inf riures doivent tre surveill es de pr s NOTA La cheville fournit une source capitale d informatioons sensorielles particuli rement importantes pour les personnes Eg es Des s ances r p t es d entra nement de stabilit dans lesquelles l articulation se d place proche de ses limites entra nent une augmentation de la tonalit musculaire une sensibilit am lior e et des r ponses somato sensorielles plus vives 4 3 CLINICAL CONSIDERATIONS 5 APPLICATIONS ORTHOPEDIC AND SPORTS MEDICINE 1 Bilateral Balance Activities e Select desired training mode Begin at level 12 or static and progress as tolerated Begin with handrails in the upright position and progress to lowering them Move platform as per training protocol Use ball toss drill to increase eye hand coordination 2 Unilateral Balance Activities e Select desired training mode e Begin at level 12 or static and progress as tolerated e Begin with handrails in
110. ss This setting brightens or darkens the display screen for all applications 1 Atthe Configuration screen simply touch along the LCD Brightness Bar Scale until the desired display brightness is achieved The left end of the scale is darkest the right end of the scale is lightest Adjust Tone Volume This setting raises or lowers the volume of the audible tone which signals test or exercise start completion and countdown between trials 1 Atthe Configuration screen simply touch along the Tone Volume Bar Scale until the desired level is achieved The left end of the scale is least loud the right end of the scale is most loud Select Measure Units Printer Resolution or Joystick Emulation All three of these setting are simple toggle choices Simply touch the desired parameter to view the choices then touch the setting you want to select e Measurer Units Metric or US e Printer Resolution normal or high joystick Emulation disabled or enabled SYSTEM UTILITIES 116 PATIENT MANAGEMENT See Figure 11 4 11 6 At the System Utilities screen touch Patient Management gt and then enter 781 in response to the Enter Access Code prompt Touch lt OK gt The Patient Management screen should now be dis played This screen shows a listing of patients and associated saved test and training sessions along with the date performed Use the lt A gt or lt W gt arrows to scroll through the list of patient tests Patient Manag
111. ssary to re distribute the existing grease A CAUTION Some steps of these procedure require the Balance System to be turned ON When this is the case use extreme caution working on the system f ATTENTION Certaines tapes de la pr sente marche suivre n cessitent que le syst me d quili brage soit mis SOUS TENSION En pareille circonstance user de pr cautions extr mes dans la maniplation du syst me 19 1 GENERAL MAINTENANCE APPENDIX A CALCULATION OF LIMITS OF STABILITY DIRECTION CONTROL DIRECTION CONTROL SCORE Straight Line Distance to Target X 100 Actual Distance Traveled WHERE Pp t V 1 4 4 La Actual I Straight Line Distance to Distance nt Target Traveled V trace Loe s rj V s CENTER TARGET i gt DLOS Scores i OVERALL DIRECTION CONTROL SCORE m or the Average of all the eight Targets A APPENDIX A BALANCE SYSTEM CLINICAL TEST OF SENSORY INTEGRATION AND BALANCE CTSIB SWAY INDEX EQUATION Test Description The objective of this test is to quantitatively determine a score defining a patient s ability to maintain a stable vertical posture while positioned on a stationary platform The patient is posi tioned on a stable platform and instructed to try to maintain a stable vertical posture under a variety of sensatory conditions eyes open eyes closed and vision partially obscured Equipment Description Sway information is collect
112. ssessment of how well a patient can integrate various sens es with respect to balance and compensate when one or more of those senses are compromised e Condition 1 Eyes open firm surface Baseline Incorporates visual vestibular and somatosensory inputs e Condition 2 Eyes closed firm surface Eliminate visual input to evaluate vestibular and somatosensory inputs e Condition 3 Visual conflict on firm surface Some vision present but information conflicts with vestibular information This condition brings in more vestibular and somatosensory inputs e Condition 4 Eyes open on a dynamic surface used to evaluate somatosensory interaction with visually input e Condition 5 Eyes closed on dynamic surface used to evaluate somatosensory interaction with vestibular input e Condition 6 Visual conflict on dynamic surface Used to evaluate the mediation of visual with and vestibular and somatosensory inputs Another version of this test called the modified CTSIB is often used The m CTSIB eliminates conditions 3 and 6 Biodex Balance products use the m CTSIB format of 4 conditions as the default with the ability to include the other 2 if desired A note concerning eye glasses for the Visual Conflict condition Clinicians that want to do the Visual Conflict conditions will require some type of glasses that provide a distorted yet transparent image Commercially available Prism type glasses are com monly used Other improvised glasses ar
113. st screen With the patient ready to begin the test touch Collect Data The screen will provide a three second countdown before beginning the first of three test trials The display screen will show Test Trial Time Platform Setting and Stance to the left of the grid Trial Number and score are displayed to the right of the grid NOTE To stop a test in progress at any time and return to the Limits of Stability Testing screen with the platform locked touch Cancel or Stop When the first trial is finished the screen will display Trial 1 Complete the platform will return to the locked position and a 10 second rest countdown will begin for the second trial Touch Collect Data gt to begin the second test trial and continue in the same manner to complete trials two and three After completing the test a Test Complete message is displayed Touch lt Results gt to advance to the Limits of Stability Test Results screen At the Limits of Stability Test Results screen touch Print to automatically generate a printed report if desired If you have performed a Bilateral Test the Test Results screen and report will provide a bilateral comparison To save the test data touch Save Results and then touch lt OK gt in response to the Save Results for later reporting or export prompt The system will display Save Results Completed after the results are saved To return to the Opening Menu from the Limits of Stability Test
114. stion and confirm 2 e D Home Confirm 8 19 TESTING Reference Mcllroy WE Maki BE Preferred placement of feet during quiet stance development of a standardized foot placement for balance testing Clinical Biomechanics Vol 17 No 1 66 70 1997 3 Ifyou do not want to follow the default test conditions Select More Options Here you can set the Test Trial Time enter the number of trials adjust the Rest Countdown and change which conditions you want to test by simply touching to highlight the conditions you want to do You can also toggle the cursor ON OFF The cursor should be OFF during the actual test Touch lt OK gt to confirm your selections and return to the Testing screen e Use the lt A gt or lt W gt keys to set the Test Trial time in five second increments during the routine the system will count down from the time setting selected To set the number of trials or rest countdown touch the appropriate key and then enter the setting from the keypad displayed m CTSIB Testing Options Choose Conditions Visual Conflict Firm Surface Cursor Visual Conflict Foam Surface a o on o 2 TESTING 8 20 Press lt OK to continue to do the test The Press lt START gt to being the testing sequence for each condition Again as with the other tests you will have the option to perform a trial rep prior to each test condition rep The practice rep
115. t W gt keys to set the total hits NOTE Total hits must be set before you can set beginning and ending platform stability e To set initial platform stability touch the appropriate key and then enter the setting from the keypad displayed static 12 is most stable 1 is least stable Touch lt OK to return to the Weight Shift Training Options screen and set the ending platform stability in the same manner e To turn tracing ON OFF touch lt Tracing gt to toggle between choices At the Weight Shift Training screen touch the lt A gt or lt W gt keys to select the desired plat form stability if not already selected static 12 is most stable 1 is least stable Explain the training protocol to the patient and then press lt Start gt on the display to begin the training session The Stability Training grid on the screen charts the patient s stability per formance through the course of the training session touch the Magnifying Glass to enlarge the screen if desired The Elapsed Time from the start of the training session is shown at the top right of the display while the stability level is illustrated by a bar graph in the upper right corner A running patient score is also provided in the upper right corner Note that the stabil ity level of the foot platform can be changed at any time during the exercise session NOTE If you have selected to enlarge the screen by touching the Magnifying Glass you must return to the normal view
116. t en tirant sur le verrou To Adjust the Display Height 1 Loosen the Display Height Locking Knob 2 Pull up or push down on the display until the desired height is achieved 3 Tighten the locking knob to secure the display in the desired position NOTE Position the display so that the patient can look straight at it This will help ensure good posture during the test or exercise session Pour adjuster la hauteur de l ecran 1 Desserrer la mollette de r glage de hauteur 2 D placer l cran la hauteur voulue 3 Serrer la mollette To Adjust the Display Tilt 1 Simply tilt the Display as required by patient or testing exercise protocol Ajustement de l inclinaison de l ecran 1 Pivoter l cran pour obtenir l angle voulu 3 3 ASSEMBLY amp INSTALLATION Auxiliary Serial and NEW 12 1 Hich resoluti M AN A a USB Printer Ports touch screen LCD display Adjustable height display to accommodate each patient Adjustable support handles Color printer with stand included Features both static and dynamic Locking surface ensures Transport balance capabilities safe on off patient wheels allow movement easy relocation Figure 3 3 Balance System adjustment mechanisms ASSEMBLY amp INSTALLATION 3 4 N 4 CLINICAL CONSIDERATIONS Prior to allowing any patient to use this device make certain to read and comprehend this entire manual Ensure that you are completely familiar wit
117. t i i e me e E PER e fonts ec idus 11 7 12 Reimb rsement M M 12 1 19 General Maintenance siimi cided an dieere tere tete tud test dias 13 1 Appendix A Calculation of Limits of Stability Direction Control sss A 1 Appendix B Normative Data Referenced in Predictive Values Report B 1 Appendix C CTSIB Normative Data Collection and Reliability sss C 1 Appendix D Balance Overview urne teet Pana ie age terii eni eee ndi D 1 Appendix E Electromagnetic Compatibility nus E 1 Appendix F Cleaning and Mainteriance eiie er he reis e E Pere e Penh vor iie hen F 1 Appendix G References Bibliography available at www biodex com balance G 1 hceEniuud R 1 lll TABLE OF CONTENTS DEFINITION OF SYMBOLS The following symbols and their associated definitions are used and implied throughout this manual Symbol Definition Carefully read these instructions prior to use Caution General Warning General Mandatory Action Dangerous Voltage On Power Off Power Earth ground Alternating Current Fuse USB Connector Cable Waste in Electrical Equipment Date of Manufacture Type B Applied Part A gt Ey i o o CE Mark an E Certified for Safety by ETL Intertek Intertek DEFINITION OF SYMB
118. t of the Center of Gravity COC This is then further defined as a percentage of the patients s Limits of Stability At 10076 of the LOS a patient will fall if they don t respond appropriately Center is established in the test protocol during the centering process where patients must posi tion themselves so the platform is flat and the cursor is centered In actuality this process is to position the COG over the point of the vertical ground reaction force An Anterior Posterior Stability Index of 6 8 means the average displacement from center is 6 8 degrees LOS for A P motion is 12 degrees In this case the patient was able to control their bal ance to remain within 57 of their A P LOS Balance is a complex process involving visual vestibular and neuromuscular control The Biodex Balance System will prove to be a more sensitive test of balance performance because being a dynamic tilting platform it will invoke the neuromuscular control aspects more so than a static force plate type system as well as the visual and vestibular components The Biodex Balance System will provide an accurate reliable assessment of a patient s balance performance This objective measure can be correlated to actual functional activity performance fall incidence and fall direction In addition balance mobility programs can be evaluated through objective assessment of the effects of lower extremity exercise on balance performance INTERPRETING PATIENT PERFO
119. t range Create Save and Recall Custom Protocols Custom protocols are organized as those for Training and those for Testing Creating protocols are the same for either case 1 D In System Utilities Select lt Custom Protocol List gt 09 09 2010 Utilities 4 44 59 PM Configuration Patient Management Custom Protocol List Patient Data Storage Usage Upper Display Module UDM Biodex SW PN 950 300 E617 Firmware Version 1 41 09 09 2010 PC104 Firmware 1 00 SGB Firmware 1 10 Back Hours Of Use 1 2 A Custom Protocol list will appear 3 Select Create Protocol gt Custom Protocol List Protocol 20s 12 5 tone 20s h 12 3 targs 20 secs 7 11 35 2 7 8 1 4 targs a Test Type MCTR XWBTR PSTR FRT PSTR ASL ASL ASL Lock Platform Next a lt p Create Protocol Back o Delete 7 15 THE TRAINING MODES 4 Select Training or Testing Protocol creation is same for both 5 Alltarget placements and goal settings are saved and recalled for custom protocols 6 Be sure to name the protocol as the protocol can then be recalled exactly as stored for reuse as a custom protocol BALANCE SYSTEM SD Training Testing Protocol Setup D Back THE TRAINING MODES 7 16 Selecting a Custom Protocol 1 To select a previously created custom protocol simply Select Custom Protocol from either Oo the Training or Testing menu scre
120. tatic testing measures the angular excursion of the patient s center of gravity Body height must come into play for static measures A person s Center of Gravity COG is approximately 55 of their height Based on the selected height an appropriate static measure scaling is applied Testing in this mode is ideal for baseline testing for movement disorder vestibular dysfunction and orthopedic patients Good static testing scores can lead to a progression into dynamic test ing and training Test formats include Postural Stability Limits of Stability Athlete Single Leg CTSIB and Fall Risk Postural Stability and Limits of Stability testing are available at variable levels of difficulty Bilateral reports comparsion of postural stability performance of standing on one leg versus standing on the other are available in More Options of Postural stability testing As with training patients with saved tests can be recalled for easy positioning from the Patient Management screen by selecting the desired patient record and touching lt Repeat gt See Chapter 11 Testing Postural Stability Limits of Stability m CTSIB Athlete Single Leg Fall Risk lt p Back Select Custom Protocol Test Information Figure 8 1 The Testing Menu screen 8 1 TESTING THE POSTURAL STABLITIY TEST The Postural Stability Test emphasizes a patient s ability to maintain center of balance The patient s score on this test assesses deviations from
121. the upright position and progress to lowering them e Move platform as per training protocol 3 Bilateral Upper Extremity Activities e Place both hands in a north south east west and diagonal position e Select desired training mode e Begin with a stable platform and progress accordingly e Move platform as per training protocol e Begin on knees and progress to toes to one knee to one foot Progress to unilateral balance palm centered on the platform FALL PREVENTION 1 Bilateral Exercises e Begin with static level weight shifts Progress to dynamic level 12 weight shifts e Use circular grid to demonstrate where tendency to fall occurs e Have patient perform both anterior posterior and medial lateral exercises 2 Unilateral Exercises e Have patient hold platform steady and illustrate how well the patient holds the platform stable Different patterns circles anterior posterior medial lateral to increase strength of the lower extremity 3 Fall Risk Assessment Testing 4 CTSIB Testing A REFERENCE NOTES 1 Caution must be noted when performing this activity Ensure that the patient has the ability to handle this challenging activity 2 Ensure proper bilateral stabilization prior to unilateral stabilization 3 Ensure that patient uses the handrails as needed 4 Ensure that bilateral and unilateral static stability are adequate prior to progressing to unilateral dynamic stability 5 The more unstable the plat
122. tient s stability per formance through the course of the training session touch the Magnifying Glass to enlarge the screen if desired The Elapsed Time from the start of the training session is shown at the top right of the display while the stability level is illustrated by a bar graph in the upper right corner A running patient score is also provided in the upper right corner Note that the stabil ity level of the foot platform can be changed at any time during the exercise session NOTE If you have selected to enlarge the screen by touching the Magnifying Glass you must return to the normal viewing screen format to make any changes At any time during the training session the tracing can be erased by pressing Clear Tracing gt To stop the training session at any time press lt Stop gt on the display The system will stop gathering data and the platform will advance to the locked position When you are finished reviewing the Random Control Training screen touch lt Print gt to print the screen or Save Results to save the training session numeric data only After printing or reviewing the screen press lt Start gt to immediately begin another training session using the same parameters or press lt Back gt to return to the Training Setup screen THE TRAINING MODES 7 12 PERCENT WEIGHT BEARING TRAINING See Figures 7 7 and 7 8 Percent Weight Bearing Training provides real time feedback of the percent
123. tion of the mean and N 1 2 2 sqrt Z Xn ox Yn oy n 0 N Anterior p Posterior A 3 APPENDIX A APPENDIX B NORMATIVE DATA REFERENCED IN PREDICTIVE VALUES REPORT Joan A Finn D P E Exercise Science Department Southern Connecticut State University New Haven CT May 2010 Testing Protocol The testing protocol consisted of three 20 second trials using the postural stability testing feature within the BSD software During each test trial the platform gradually became less stable at four second intervals The initial stability level was set at level 12 and ended at level 8 Participants were given a 10 second rest between each of the three trials Data Analysis Statistical tests were carried out using the Statistical Package for the Social Sciences SPSS Inc Chicago IL Data were analyzed using ANOVAs with age and balance ability as the independ ent variables The Bonferroni post hoc test was applied as necessary The confidence level was set at 0 05 RESULTS Table 1 and Table 2 include descriptive statistics for age and balance independent variables Statistical analyses identified significant differences in balance scores for both independent vari ables These differences are included in the text presented after each Table Table 1 Stability Index Differences among Age Groups Youngest Sec youngest Third oldest Oldest Group 1 Group 2 Group 3 Group 4 Age 18 35 36 53 54 71
124. to return to the Maze Control Training Options screen and set the ending platform stabili ty in the same manner e To turn tracing ON OFF touch lt Tracing gt to toggle between choices 11 At the Maze Control Training screen touch the lt A gt or lt W gt keys to select the desired plat form stability if not already selected static 12 is most stable 1 is least stable 12 Explain the training protocol to the patient and then press lt Start gt on the display to begin the training session The Stability Training grid on the screen charts the patient s stability performance through the course of the training session touch the Magnifying Glass gt to enlarge the screen if desired The Elapsed Time from the start of the training session is shown at the top right of the display while the stability level is illustrated by a bar graph in the upper right corner A running patient score is also provided in the upper right corner Note that the stability level of the foot platform can be changed at any time during the exer cise session NOTE If you have selected to enlarge the screen by touching the Magnifying Glass you must return to the normal viewing screen format to make any changes 13 At any time during the training session the tracing can be erased by pressing Clear Tracing gt 14 To stop the training session at any time press lt Stop gt on the display The system will stop gathering data and the platform will a
125. tomatiquement en position bloqu e De la m me facan si le syst me n est pas utilis pendant un intervalle de 3 minutes il se bloque R gler l appui et l ecran pour maximizer le confort et la s curit du patient Pour des patients post op ratoires v rifier avant de les faire monter sur le plateau qu ils sont capables de stabiliser leurs articulations Un contrile insuffisant pourrait les mettre risque Si les patients travaillent les yeux ferm s il faut se tenir pr t les aider ou mettre en place l appui Puisque l utilisation du plateau de stabilit sollicite toutes les articulations de l extr mit s assurer que les cicatrisations sont suffisamment avanc es pour supporter l exercice Les r sultats sont meilleurs avec le patient plac au milieu du plateau Les patients doivent d marrer avec l appui et apprendre progressivement ne plus s en servir De cette facon les patients d veloppment leur compr hension du plateau de stabilit en minimisant les risques La courbe d apprentissage du syst me peut influencer les r sultats d un examen La litt rature clinique sugg re qu il faut r aliser trois examens blanc avant de faire un examen d finitif R gler l cran droit devant les yeux du patient Ceci aidera maintenir une bonne position pendant l exmen ou l entra nement ADDITIONAL CONSIDERATIONS FOR FALL PREVENTION PROGRAMS In addition to the above the following considerations should also be cons
126. tters an electromagnetic site survey should be consid ered If the measured field strength in the location in which the Balance System SD is used exceeds the applicable RF compliance levels above the Balance System SD should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the Balance System SD Over the frequency range 150 KHz to 80 MHz field strengths should be less than 3 V m LES Electromagnetic environment guidance Mains power quality should be that of a typical commercial or hospital environment If a better mains power quality is required it is recommended that the Balance System SD is powered from an uninter ruptible power supply If image distortion occurs it may be necessary to position the Balance System SD display further from sources of power frequency magnetic fields or to install magnetic shielding The power frequency magnetic field should be measured in the intened installation location to assure that it is sufficiently low Portable and mobile RF communications equipment should be used no closer to any part of the Balance Sysem SD including cables than the recommended sep aration distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d 12 P 150 KHz to 80 MHz d 1 2v P 80 MHz to 800 MHz d 23 P 800 MHz to 2 5 GHz
127. tween left and right leg positioning Touch lt Tracing gt to toggle tracing ON or OFF as desired Touch Clear Tracing gt to clear any tracing that remains from previous tests Touch More Options to advance to the More Options screen if desired Here you can set the Test Trial Time enter initial and ending platform stability settings enter the number of trials and enter the Rest Countdown You can also toggle the cursor ON OFF Touch lt OK gt or confirm your selections and return to the Athlete Single Leg testing screen e Use the lt A gt or lt W gt keys to set the total time in five second increments during the routine the system will count down from the time setting selected NOTE Total time must be set before you can set beginning and ending platform stability e To set initial or ending platform stability static 12 is most stable 1 is least stable touch the appropriate key and then enter the setting from the keypad displayed Touch lt OK gt to return to the Athlete Single Leg Stability Testing Options screen and set the ending platform stability in the same manner e To set the number of trials or rest countdown touch the appropriate key and then enter the setting from the keypad displayed e To turn the cursor ON OFF touch Cursor to toggle between choices TESTING 8 12 14 Press lt Start gt to release the platform if not static and activate the Limits of Stability Test screen 15 W
128. ty index The stability index represents the vari ance of platform displacement in degrees from level A high number is indicative of a lot of motion which is indicative of the patient having trouble balancing Differences between right and left limbs can be noted Orthopedic problems many times present neuromuscular control problems You will see this by testing single leg involved and uninvolved Balance training will improve their control Geriatric patients can also be tested for excessive sway The direction of the sway is important with regards to the predisposition of a falls direction Falling to either side significantly increas es the chances of a hip fracture 1 2 3 References 1 Cumming Robert G Klineburg Robin J Fall Frequency and Characteristics and the Risk of Hip Fractures JAGS 42 774 778 1994 2 Nevitt Michael C Cummings Steven R Hudes Estie Risk Factors for Injurious Falls A Prospective Study Journal of Gerontology Medical Sciences 46 5 M164 170 1991 3 This information was presented in abstract form at the New England Chapter of the American College of Sports Medicine Thursday October 1 1998 It is titled Stability Performance Assessment Among Subject of Disparate Balancing Abilities J A Finn M M Alvarez R E Jett D S Axtell D D Kemler Exercise Science Department Southern Connecticut State University New Haven CT TESTING 8 6 THE LIMITS OF STABLITIY LOS TEST This t
129. uals there is no significant difference in sway with eyes open or closed on a firm surface 3 Eyes Open Unstable foam surface The unstable surface confounds the somatosensory information as it imposes additional challenges to the musculoskeletal system Primary inputs are visual with vestibular as secondary Normal individuals will sway more on the unstable sur face but will not fall 4 Eyes Closed Unstable foam surface This condition focuses on the vestibular sensory input as visual is not available and somatosensory is challenged by the unstable surface Again nor mal individuals will sway more on the unstable surface but will not fall To interpret or apply the test results consider under what condition was sway the greatest Normal balance includes the ability to hold still in various situations depending on the activity or circumstance demands The COG sway scores indicate how well the patient accomplished this Lower scores reflect little movement which are consider better than higher scores which reflect more movement Firm Surface Eyes Open vs Eyes Closed Normal individuals standing on a firm surface have similar amounts of sway with eyes open or closed On a firm surface when significantly more sway is present with eyes closed then the patient maybe having difficulty using somatosensory inputs this is the input up from the feet An ankle strategy should be used for primary balance control on a firm surface Unstable Fo
130. ustable support bandles Color printer with stand included Features both static and dynamic Locking surface ensures Transport balance capabilities safe on off patient wheels allow movement easy relocation Ethernet connection accommodates wired and wireless printing Figure 1 1 The Biodex Balance System SD primary components and adjustment mechanisms Fil INTRODUCTION Featuring five test protocols six training modes and intuitive touch screen operation the Balance System SD allows testing and training in both static and dynamic formats Extremely ver satile it is the only system that provides fast accurate Fall Risk Screening and Conditioning for older adults used as a balance assessment tool for concussion management plus closed chain weight bearing assessment and training for lower extremity patients Using this unique device clinicians can assess neuromuscular control by quantifying the ability to maintain dynamic bilateral and unilateral postural stability on a static or unstable surface Use any of five test protocols including Fall Risk Screening Athletic Single Leg Injury Screening Dynamic or Static Limits of Stability Postural Stability and Clinical Test of Sensory Integration of Balance CTSIB The Balance System SD also serves as a valuable training device to enhance kinesthetic abilities that may provide some degree of compensation for impaired proprioceptive reflex mechanisms following i
131. vider use of dynamic activities to improve functional performance each 15 minutes Self care home management t raining eg activities of daily living ADL and compensatory training meal preparation safety procedures and instructions in use of assistive technology devices adaptive equipment direct one on one contact by provider each 15 minutes Physical performance test or measurement eg musculoskeletal functional capacity with written report each 15 minutes Canalith Repositioning specific maneuvers for BPPV NOTE Most insurance plans including Medicare cover assessment and conditioning for Fall Programs 1425 SYSTEM REIMBURSEMENT 13 GENERAL MAINTENANCE The Biodex Balance System requires only the most basic general maintenance performed on an as needed basis at least every three to four months CLEANING INSTRUCTIONS With the system turned OFF wipe down all surfaces with a damp cloth Mild soap and water can be used to remove stains and scuff marks As needed inspect all locking and adjustment mechanisms for signs of wear or damage If you have any questions or need further assistance contact the Biodex Customer Service Department GENERAL MAINTENANCE PROCEDURES e Lubricate the spring assemblies with white lithium grease e Lubricate the eight push plates with white lithium grease e Lubricate the acme threaded rods with white lithium grease NOTE When checking for lubrication it may only be nece
132. where P is the maximum output power rating of the transmitter in watt W according to the transmitter manufacturer and is the recommended separtion distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equip ment marked with the following 9 symbol APPENDIX E Recommended Separation Distances Recommended separation distances between portable and mobile RF communications equipment and the Balance System SD Table 6 The Balance System SD is intended for use in the electromagnetic environment in which radiated RF disturbance are controlled The customer or the user of the Balance System SD can help prevent elec tromagnetic interference by maintaining a minimum distance between portable and mobile RF com munication equipment transmitters and the Balance System SD as recommended below according to the maximum output power of the communication equipment Rated maximum output power of transmitter W Separation distance according to frequency of transmitter m 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz d 12vP d 12vP d 23vP 0 01 0 23 0 1 0 73 1 23 10 73 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applica
133. yed 9 If desired touch Clear Tracing gt to remove any tracing that remains on the screen from a previous exercise session 10 Touch More Options to advance to the Maze Control Training Options screen if desired Here you can set the total time for the exercise enter initial and ending platform stability settings change sensitivity and turn tracing ON OFF Touch lt OK to confirm your selec tions and return to the Maze Control Training Options screen or Cancel to return to the Maze Control Training Options screen without making changes Maze Control Training Options 7 Scoring Tone Tracing Cursor 3 rer E Cursor Sensitivity OK Total Time Figure 7 5a The Maze Control Training Options screen e Use the lt A gt or lt W gt keys to set the total hits Increase Cursor Sensitivity e Some patients may find it difficult to move their center of gravity to reach objects in the boundary areas of the field of play This can often be compensated for by selecting a shorter height for the patient In the case of the Maze or Random control training the ability to increase the cursor sensitivity even more was added NOTE Total time must be set before you can set beginning and ending platform stability 79 THE TRAINING MODES e To set initial platform stability touch the appropriate key and then enter the setting from the keypad displayed static 12 is most stable 1 is least stable Touch lt OK gt
134. yes open firm high value is 48 The noted value is 50 b Eyes closed firm high value is 99 The noted value is 1 0 c Eyes open foam high value is 71 The noted value is 75 d Eyes closed foam high value is 2 22 The noted value is 2 25 The end point for the RED zone is three times the mid point Basically three standard deviations from the mid point See Balance Overview and the CTSIB report interpretation sections for more specific information TESTING 8 22 9 REPORTS Biodex Balance System SD offers reports for each of the five test modes These can be used to objectively measure and record the patient s ability to stabilize the involved joint under static or dynamic stress Reports can be generated to reflect single leg both legs and bilateral comparison testing protocols Report formats include Postural Stability Limits of Stability Athlete Single Leg CTSIB and Fall Risk Progress reports that graph overall stability scores from each test date are also available Sample reports for each testing mode are provided later in this chapter REPORT PARAMETERS DEFINED The following parameters appear on various reports Stability Level Indicates the stability stiffness of the foot platform When locked the foot plat form is fully stable A setting of 12 is the most stable released setting A setting of one is the least stable foot platform setting Stability settings of 12 through one allow the foot platform a fu

BALANCE SYSTEM SD - Biodex Medical Systems

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