Manual, Offset Unweighing System Installation/operation

Transcript

UNWEIGHING SYSTEM INSTALLATION/ OPERATION MANUAL 945-480 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: [email protected], www.biodex.com FN: 08-149 Rev C 8/14 UNWEIGHING SYSTEM This manual covers installation and operation procedures for the following Biodex product: #945-480 Unweighing System Authorized European Community Representative: EC REP Emergo Europe Molenstraat 15 2513 BH, The Hague The Netherlands — II — TABLE OF CONTENTS 1. importaNt safety iNformatioN....................................................................................... • Warning, Caution and Information Symbols ................................................................................ 2. before proceediNg..................................................................................................................... 3. iNtrodUctioN ................................................................................................................................ • Partial Weight Bearing Gait Therapy and Balance Training ...................................................... • Benefits of Dynamic Unweighing Therapy ................................................................................... 4. assembly iNstrUctioNs .......................................................................................................... • Assembling The Unweighing System ............................................................................................ 5. UsiNg tHe biodeX UNWeigHiNg system ......................................................................... • Steering Casters.................................................................................................................................................. • Positioning the Unweighing System for use with the Biodex Gait Trainer and RTM Treadmill..................................................................................................... • Positioning the Unweighing System for use with the Biodex Balance System ....................... • Determination of Body Weight Support ........................................................................................ • Using the Universal Air Support Harness..................................................................................... • Attaching a Patient to the Unweighing System............................................................................ • Safety Tether Operation.................................................................................................................... • Free Wheeling..................................................................................................................................... • Jogging................................................................................................................................................. • Ambulation Stool ............................................................................................................................... 6. maiNteNaNce aNd safety iNspectioN ........................................................................... • Cleaning .............................................................................................................................................. • Inspection ............................................................................................................................................ 7. specificatioNs ............................................................................................................................... 8. bibliograpHy ................................................................................................................................. 9. electromagNetic compatibilty ...................................................................................... 10. replacemeNt................................................................................................................................... — III — TABLE OF CONTENTS DEFINITION OF SYMBOLS D The The ffollowing ollow wing symbols symbols a and nd ttheir h e ir a associated ssociated de definitions finitions are used sed an and m a n u a l. arre u d iimplied mplied tthroughout hroughout this this manual. Symbol Definition Carefully re Carefully read ad tthese hese iinstructions prior use nstructions p rior tto ou se Caution Ca u tio n General Warning Ge n e ra l W a r n in g General Mandatory Action t io n Ge n e ra l M andatory Ac Da ngero us V o lta g e Dangerous Voltage “On” “O n” Power Pow er “Off” “O ff” Power Pow er Earth Ear th ((ground) g ro u n d ) Alternating Current Current Alternating Fuse Fuse USB US B Connector/Cable Connector/Cable Wa ste iin nE le c t r ic a l E quipment Waste Electrical Equipment Date off M Manufacture Da te o a n u fa c tu r e Type Applied Part Ty pe B A pplied P a rt Mark CE M ark Ce Certified rtified ffor or S Safety a fe ty b by yE ETL TL IIntertek n te rte k Biodex Medical Systems, Inc. © 2012 DEFINITION OF SYMBOLS — IV — BEFORE PROCEEDING Before you get started with any of the setups described in this manual, there are a few preliminary points to consider which will help ensure safe and smooth operation of your Biodex Unweighing System. • This system should be operated only by qualified personnel. • Be aware that use of Biodex technology requires professional expertise for discerning appropriate 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 setups and positioning with a healthy subject before attempting to set up an injured patient. 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 product 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. ATTENTION: Des Modifications à ce produit ne sont pas autorisées. Modification non autorisée du produit peut entraîner des risques pour l'opérateur et le patient et annulera la garantie du fabricant. Ne modifiez pas cet équipement sans l'autorisation du fabricant. WARNING: If this equipment is modified, appropriate inspection and testing must be conducted to ensure continued safe use of equipment. AvERTIssEmENT: Si cet équipement est inspection modifiée, appropriée et essais doivent être effectués pour s'assurer a continué l'utilisation sécuritaire de l'équipement 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 [email protected] —V— BEFORE PROCEEDING IMPORTANT SAFETY INFORMATION WarNiNg, caUtioN aNd iNformatioN symbols The following caution and warning symbols and their associated meanings are used throughout this manual: Refer to Instruction Manual/Booklet General Warning Sign General Mandatory Action Sign Waste in Electrical Equipment Models that bear the ETL Monogram have been Certified for Safety by ETL Intertek in accordance with CAN/CSA C22.2 No.:601-1-M90. CE conformity to IEC 60601-1, EMC compliance to EN 60601-1-2. "ON" (Power) Caution Date of Manufacture 0413 CE Mark Type B applied part Kg Lb Kilogram Pound Follow the unpacking and assembly instructions document. 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 documents for future reference. Make certain to understand all warning and caution labels as explained in the Before Proceeding section of this manual. The Unweighing System should be used only as specified in the operation manual. The Unweighing System is designed for use in a patient environment. See Section 7 for Unweighing System specifications. This medical electrical equipment required special precautions regarding EMC and needs to be installed and put into service according to EMC information provided in this manual. Electromagnetic compliance definition is provided in Section 9. Reference Cleaning and Maintenance Section 6. Operation for: 9V Battery. IMPORTANT SAFETY INFORMATION — VI — UNWEIGHING SYSTEM WARRANTY 1. instrumentation 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 shipment from BIODEX MEDICAL SYSTEMS, INC. During the warranty period, BIODEX MEDICAL 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 SYSTEMS, 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 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. — VII — WARRANTY CONTENTS 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 that 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’l 631-924-9000) Fax: 631-924-8355 Email: [email protected], www.biodex.com WARRANTY — VIII — 1. INTRODUCTION Single point suspension permits functional pelvic rotation and versatility when walking, side-stepping, retro-walking and turning Dynamic suspension allows for natural vertical displacement of center of gravity Attachment rings - on support vest allow single or two-point pelvic stabilization when desired Real time digital scale displays off-loaded weight in pounds or kilograms Unweighing Harness fits a variety of patients Two position handle for easy and efficient patient unloading Patented off-loading mechanism maintains constant force Accommodates children and adults Simply dial in amount to offload If pelvic stabilization is required, the Biodex Unweighing System includes Pelvic Stabilization Straps to govern the degree of pelvic rotation. Stabilization straps are made of Thera-Band® and adjustable nylon hooks. Adjust to fit 8' ceilings Offset frame design offers improved access to manually assist patient footfall and weight shift Large locking casters for effortless mobility over ground Removable and adjustable patient handrails Removable Therapist seats provide a place to sit during assistive exercise and provides a safer environment for therapist interaction Figure 1. The Biodex Unweighing System adjustment mechanisms. partial WeigHt beariNg gait tHerapy aNd balaNce traiNiNg The loss of the ability to ambulate can be one of the most debilitating aspects of many neurological and musculoskeletal disorders. Any of the three main components of locomotion - posture, balance and coordination - can be affected by a variety of neurologic or musculoskeletal pathologies resulting in the disruption of an individual’s ability to walk normally. Partial Weight Bearing Gait Therapy (PWB) has shown great promise in helping a wide variety of impaired patients as they relearn walking function. It is an appropriate modality to use whenever gait therapy is prescribed for patients who are unable to support their own body —1— INTRODUCTION CONTENTS weight or lack the upper body strength to support themselves during assisted ambulation. In addition to aiding gait pattern regeneration, partial weight bearing therapy allows patients to perform cardiovascular workouts in conjunction with a treadmill, enhance balance and improve posture. Partial Weight Bearing Gait Therapy makes use of a patient suspension system, such as the Biodex Unweighing System, to reduce the amount of weight born by a patient and provide proper upright posture. The suspension system is used to remove a pre-determined portion of the weight load from the patient’s legs and redistribute it to the patient’s trunk and upper thighs, thus freeing up the arms and legs. NOTE: Extreme caution should be taken to assure the stability of autonomic reflexes (in acute stages) as well as bone and muscle integrity (in chronic cases). With the patient supported by the suspension system, horizontal movement is provided by setting the treadmill to a slow speed. The constant rate of movement provided by the treadmill provides rhythmic input to reinforce coordinated, reciprocal movement of the legs. The therapist can provide further assistance, especially with severely involved patients, by manually placing the patient’s feet and/or assisting the patient in weight shifting. Once the patient begins to gain a feel for the proper coordinated movement pattern the treadmill speed and/or the amount of weight borne by the patient can be gradually increased to better simulate natural walking conditions. The increase in weight bearing and treadmill speed also helps the patient to relearn dynamic balance. Having achieved preset goals on the treadmill, the patient can be progressed to ambulating over ground with the aid of the suspension system. Ultimately, it is hoped the patient will be able to ambulate over ground independently or with an assistive device. PWB therapy sessions typically last 30 minutes to an hour and are scheduled three to four times per week. Each hour of the session can be divided into three or four periods of activity followed by a rest period. Activity periods can be as short as three minutes with five minutes of rest but should not exceed 15 minutes if the patient is supported or partially supported by the suspension system. Each period should end at its predetermined time, especially if the patient’s gait deteriorates or the patient or therapist feels fatigued. Because the repetition of coordinated walking patterns is the most essential element to the success of this therapy, be sure to provide consistent training without interruptions or breaks. Patients are evaluated over a two-week period and are expected to make some gains in their ability to coordinate movement during treadmill walking in this time frame. Continue the program for 8 to 12 weeks if sufficient progress is demonstrated. Continue for up to an additional four weeks for cases showing slower improvement. For acute patients who show little on no progress after the first two weeks of therapy, time may be better spent on different learning activities. The Biodex Unweighing System can be used in the recovery of balance and posture for patients with compromised posture or balance mechanisms. Toss the patient a ball to catch or provide perturbation manually to challenge their balance. The suspension system will prevent the patient from falling while providing proprioceptive cues. The amount of support can be reduced as the patient progresses. INTRODUCTION —2— CONTENTS beNefits of dyNamic UNWeigHiNg tHerapy Partial Weight-Bearing Therapy, also known as Unweighing, is a concept of rehabilitation that uses an external device to support a percentage of the patient’s body weight, allowing them to perform a variety of therapeutic activities in an upright and safe environment. Typically used with Neurological Pathologies, the patient’s body weight is supported between 20-40% to assist with developing proper gait patterns and improvements in cardiovascular and muscular endurance with less physical demand. The ability to initiate exercise early in the rehabilitation process can benefit the patient by allowing development of neural pathways through muscular patterning. benefits Research has shown the benefits of Unweighing to occur in a variety of physiological ways. physiological benefits symmetrical Loading of the Lower extremities - This assists with equal weight distribution over the base of support. Equal weight distribution in turn provides the proper biomechanics to correct step length deficits and time distribution between limbs Reduction of muscular splinting - Parasympathetic tones typically associated with neurological pathologies can be reduced through partial-weight therapy. Minimizing parasympathetic stimuli helps to reduce muscular tension in turn allowing for increased range of motion and focus on motor control exercises. Reduction of Cardiovascular and metabolic Demands - Relieving graded portions of body weight allow the patient to exercise with less stress to the cardiopulmonary system, this is beneficial for extremely deconditioned patients as it allows them to initiate exercise without increasing cardiopulmonary demand. VO2 levels are maintained better at 40% unweighing than at 0%, the patient can then also exercise for a longer period of time. This application can be beneficial for cardiac and pulmonary rehabilitation, as well as obese patients as exercise can be prolonged to enhance conditioning. other benefits Acute Injury and Post surgical - Unweighing can also provide a safe environment to start acute therapy following injury or surgical procedures. This is especially true with patients suffering from low back pain, whether it’s acute or chronic. Unweighing provides an environment around the injured joint with reduced gravitational effects, this can be coupled with exercise to enhance joint stability. Vertical traction is accomplished to provide patient relief. This same approach can be taken with other orthopedic injuries. By using the Biodex Unweighing System you can be assured that your patient is working in a dynamic environment unloaded to physician specifications. Since the weight of the patient is supported, there is increased safety for them and the clinician, should a fall occur. Balance Training - The Biodex Unweighing System provides a safe environment during balance training. Securing your patient in the Unweighing System will eliminate the risk for falling during balance training. The somatosensory input provided by the harness provides proprioceptive feedback in regards to location of the trunk over the base of support and will allow your patient to work with more confidence during rehabilitation. —3— INTRODUCTION CONTENTS benefits specific to the biodex Unweighing system Oscillation of Center of Gravity (COG) - Normal oscillation for the center of gravity during gait is approximately 2" (5cm). This is easily achieved with the dynamic suspension of the Biodex Unweighing System. By allowing oscillation, the patient is able to maintain a smooth gait pattern (Hoppenfeld). When a static support system is used and the center of gravity is raised, the system is not able to maintain a constant unweighing. During toe off, the patient may actually be full weight bearing, which may cause undesired firing patterns of the musculature, resulting in poor training effects. Knee Flexion Throughout Gait Cycle - In order to provide for shock absorption and mechanical efficiency, the knee must flex at various points during the gait cycle. During toe off the COG will rise, the knee flexes to approximately 40º to counterbalance this effect. A static unweighing system will not allow this to occur and will therefore promote poor mechanics during gait training. Poor mechanics can lead to increased stress placed on compensatory joints and muscles and also inappropriate motor control patterns. Knee flexion also allows ground reaction forces (GRF) to occur. GRFs are important for motor firing patterns associated with motor pattern and central pattern generators. The dynamic environment of the Biodex Unweighing System allows for development and utilization of these GRF in the re-training of gait. single Point Design - A single point of suspension allows proper shifts of the COG and proper pelvic rotation during gait. By providing natural shifts of the COG strengthening and coordination can be rehabilitated to their original state. Unweighing Systems that provide a two point support design do not allow for the necessary shift of the COG over vital points necessary for gait. A two point design suspends the patient in a static "hanging" position, not allowing lateral pelvic tilts and pelvic rotation necessary for efficient gait mechanics. Lateral pelvic tilt of approximately 1" allows the body weight to be centered over the hip, this allows the non-weight bearing leg to swing through. The pelvis then rotates forward with the weight bearing hip acting as a fulcrum allowing forward movement of the non weight bearing limb. The single point design of the Biodex Unweighing System allows for proper biomechanics of the pelvis and utilization of trunk musculature for stabilization and forward propulsion. Digital Display of Unweighing Load - The digital display incorporated on the Biodex Unweighing System provides feedback in regards to the amount of weight being relieved from the patient. This is beneficial as it allows for consistency between treatments thus providing a therapeutic environment to improved gait mechanics and neurological patterning. INTRODUCTION —4— 2. ASSEMBLY INSTRUCTIONS assembliNg tHe UNWeigHiNg system In some instances, the Biodex Unweighing System is shipped assembled. If your system is not assembled complete the following steps. Tools Required: 9/16” socket wrench, small knife WARNING: At least two people are required to complete the following procedure. Ensure that the unweighing system will be assembled on a level surface. Ensure that there is enough room to move easily around the unweighing system frame during installation. Au moins deux personnes sont tenues d'accomplir la procédure suivante. Garantissez que le système non pesant sera rassemblé sur une surface de niveau. Garantissez qu'il y a assez de pièce pour bouger facilement autour de la charpente de système non pesante pendant l'installation. 1. Open the large box to reveal the top frame assembly (horseshoe). Remove the packing from around the top of the horseshoe. The side with the stop indicator and rope inspection window should face up from the floor. 2. Using a knife, slice open the box at the corners toward the foot end of the horseshoe. 3. From the smaller box, remove the left and right support legs. Lay each on the floor next to the appropriate side of the top frame assembly (See Figure 2). Lock both locking casters on each support leg. 4. Select one support leg and rotate it up so that the patient support handle pull pin points toward the floor. The high edge of the angled cut at the top end of the support leg should face toward the inside of the top frame assembly. 5. Slide one end of the top frame assembly into the support leg (See Figure 3). 6. Slide the other side of the top frame assembly into the remaining support leg as in step 5. Push both sides of the top frame assembly into the support legs until they reach the desired height as indicated by the support height label on the outside edges of the top frame assembly. NOTE: There are four position holes allowing selection for 8, 8.5, or 9-foot and greater ceilings. You must select the same hole setting for each side. Height should be determined by ceiling height of the area where the unit will be used. Be aware of exit signs, lights, fire sprinklers, etc. For the 8’5” and 9’ settings, use the supplied slotted screws and lock washers to fill the open holes on each side of the top frame assembly. 7. Secure the top frame assembly to the support legs on each side using a 9/16”socket wrench to install four sets of finishing washers, lock washer and 3/8” x .5” hex head bolt on each support leg. At this point, you only need to install the four sets on top of the support legs. 8. With the aid of another person, lift the unweighing system from the top of the horseshoe and stand it on the support legs. 9. Using a 9/16” socket wrench, install the remaining four sets of finishing washers, lock washer and 3/8” x .5” hex head bolt (two sets on each support leg.) —5— ASSEMBLY INSTRUCTIONS CONTENTS 10. Snap a black finishing cap into each of the finishing washers (eight in all). 11. Insert patient support handles into the handrail receiving tubes (See Figure 4) so that they face in toward the center of the unit. Figure 2. Lay the left and right support legs on the floor next to the top frame assembly. Figure 4. Insert patient support handles into the handrail receiving tubes. Figure 3. Slide the Top Frame Assembly into the support legs. Figure 5. Attach the Safety Harness. ASSEMBLY INSTRUCTIONS —6— 3. USING THE BIODEX UNWEIGHING SYSTEM ATTENTION: Never leave a patient unattended on this device. Check all cables, harnesses and fittings before each use. See Chapter 4, “Maintenance and Safety Inspection,” for additional instructions. ATTENTION: The Biodex Unweighing System uses a special harness to support the patient. It is vital that the harness fits properly on the patient. Refer to the Biodex Standard Unweighing Harness Operation Manual, supplied with your harness, for specific information about harness use. steeriNg casters The Biodex Unweighing System has four locking casters. Two are also steering casters. The pair of steering casters are located at the front of the system (the side with the Stop Indicator and Rope Inspection Window near the top frame corners). positioNiNg tHe UNWeigHiNg system for Use WitH tHe biodeX rtm treadmill (See Figure 6.) 1. Unlock the four locking casters. 2. Roll the unweighing system into position so the display faces toward the back of the treadmill deck. (The display should be on your right side.) The treadmill control panel should be easily accessible. The patient should be placed in the center of the treadmill belt and closer to the front than the back. 3. Lock all four locking casters. 4. Adjust unweighing as needed. ATTENTION: When using the Unweighing System with a treadmill, the steering casters should be positioned at the rear of the treadmill. This will make it easier to maneuver around the treadmill deck. positioNiNg tHe UNWeigHiNg system for Use WitH tHe biodeX balaNce system (See Figure 7.) 1. Unlock the four locking casters. 2. Roll the Unweighing System over the Balance System so the Unweighing System display faces away from the Balance System display. (The display should be on your right side.) 3. Lock all four locking casters. 4. Adjust unweighing as needed. —7— USING THE BIODEX UNWEIGHING SYSTEM CONTENTS Figure 6. The Biodex Unweighing System positioning for use with the Biodex RTM Treadmill. Figure 7. The Biodex Unweighing System positioning for use with the Biodex Balance System. Figure 8. The Biodex Unweighing System ready for free wheeling. determiNatioN of body WeigHt sUpport Heel/ground contact during ambulation is lost in patients when weight relief is in excess of 40% body weight (Visintin and Barbeau, 1989). Gardner, et al., (1988,) chose a level of weight relief in which the patient achieved heel/ground contact bilaterally for ten consecutive steps. When determining body weight support, keep in mind the patient's pathology level of involvement and comfort. A patient who is considerably challenged may require a greater percentage of weight relief. Use the scale to determine how much body weight is being lifted. The scale will show the relief amount in pounds or kilograms. For example, a reading of 30 pounds means that 30 pounds has been lifted off the patient. For a 150-pound patient, this would equal 20% of body weight. USING THE BIODEX UNWEIGHING SYSTEM —8— X UsiNg tHe UNWeigHiNg HarNess (See Figures 9-25.) The New Biodex Unweighing Harness is designed to provide vertical lift through three shared points of pressure; through the hip straps, gluteal fold straps and the lumbar-thoracic harness. The design improves comfort and prevents slippage without limiting lower extremity range of motion. Patient comfort is important so that the Unweighing System can be used for the extended periods of time necessary to achieve the vast amount of step cycles needed to improve gait. Figure 9. Optional wrap helper Take the provided neoprene wrap and apply it low across the hips in the area that the harness will eventually rest. Apply a moderate amount of tension on the wrap so that it will not slip on itself during use. This wrap prevents sliding of the harness proximally while unloading. Figure 10. Take the remaining fasten straps and fasten to the wrap. Figure 11. The bottom of the wrap should rest between the greater trochanter and the ASIS. Figure 12. Begin to apply the harness. While standing make sure the “O” rings on the harness shoulder straps fall around the level of the ears. This can be accomplished by raising or lowering the overhead bar of the Biodex Unweighing System. Figure 13. Adjust the shoulder harness straps length, which in turn adjusts the height of the harness. The bottom of the harness should be adjusted to the lower edge of the neoprene under wrap. Figure 14. Adjust the back straps on the vest so that the anterior buckle (picture 7) falls near the greater trochanter. —9— USING THE BIODEX UNWEIGHING SYSTEM CONTENTS Figure 15. Tighten the front straps to a moderate tension so that the vest feels secure to the patient. Figure 16. Notice how the anterior buckle is resting near the greater trochanter. Also notice how the lower edge of the harness falls close to the lower edge of the neoprene underwrap. Figure 17. Using the colored dots as a guide, fasten the posterior buckle of the gluteal fold strap. Figure 18. Take the remaining buckle (anterior strap) and bring it through the inside of the leg and fasten it to the anterior buckle. Figure 19. Next, fasten the thigh cuff (the thigh cuff should not be too tight, it is primarily there to hold the gluteal fold strap in place). Figure 20. Tension the gluteal fold strap until it is snug under the gluteals. USING THE BIODEX UNWEIGHING SYSTEM — 10 — CONTENTS Figure 21. Notice, when properly fitted, the anterior buckle tilts forward and allows the anterior strap to ride around the inside of the leg and not up into the crotch. Figure 22. Now is the time to apply the opposite side gluteal fold strap. Insert the posterior strap into the posterior buckle with the color-coded dots. Figure 24. Fasten the thigh cuff. Figure 25. A completed anterior view of proper vest placement. — 11 — Figure 23. Fasten the anterior buckle by bringing it along the inside of the leg. USING THE BIODEX UNWEIGHING SYSTEM CONTENTS the inguinal strap (See Figures 26-30.) In the case where you feel an inguinal strap is necessary for unweighing, there is one provided. It is simple and easy to use...just follow these five steps. Figure 26. Attach the left and right posterior straps to the posterior buckles, also color coded. Figure 27. A completed look after the posterior straps are in place. Figure 29. Do the same on the opposite side. Figure 30. Completed look of inguinal strapping system in place. USING THE BIODEX UNWEIGHING SYSTEM — 12 — Figure 28. Bring the strapping system through the legs and place the color-coded strap into the corresponding color-coded anterior buckle. CONTENTS prone Harness fixation (See Figures 31-33.) Figure 31. To apply the harness while supine, first lay the harness on a table or plinth low enough to transfer the patient. Figure 32. Apply the under wrap as mentioned above and seat the patient below the harness. Please make sure the patient is seated so the bottom edge of the wrap aligns with the bottom edge of the harness when you lay them down. Figure 33. Lay the patient down on the harness and repeat the previously mentioned steps depending on your application. Figure 35. Side handles. Used to stabilize the patient's trunk or guide them laterally in either direction. Figure 36. Strapping ring. Used to load the patient laterally and to stabilize or prevent excessive trunk rotation. other features (See Figures 34-36.) Figure 34. Release Tab. To release the patient from the Unweighing System without removing the harness, simply pull on the red tab. Make sure both you and the patient are prepared for this as the system will no longer support the patient’s load after the clamp is released. — 13 — USING THE BIODEX UNWEIGHING SYSTEM CONTENTS Adjustment: The shoulder straps can be lengthened or shortened using the end of the strap located near the seat belt buckle. The cross bar is used to adjust for patient height. ATTENTION: Be aware of incontinence concerns. Use of the unweighing harness can put pressure on the patient’s abdominal area, including the bladder. Should a harness become soiled, it can be hand-washed in warm water with mild soap - air dry. attacHiNg a patieNt to tHe UNWeigHiNg system (See Figures 9 - 37.) ATTENTION: The Unweighing System is designed to meet the hospital requirements of an eight-time load rating. The device is rated for use with patients to provide up to 180 pounds (82 kg) of unweighing load, (50% unweighing of a 360-lb patient.) NOTE: Patient set-up should be conducted over the desired walking surface (i.e, treadmill or floor,) as moving from the floor to the treadmill will require the set up procedure be repeated. Figure 37. 1. Turn on the display on the right side of the unit. Toggle ON pounds/ kilograms and then use the round knob to zero out the display. NOTE: The display shuts OFF automatically after 30 minutes. To turn the display back ON, press the button. 2. Use Handle #2 on the right side of the unit to dial in the approximate amount of weight to remove from the patient as displayed on the color-coded unloading scale. 3. Use Handle #1 on the left side of the unit to lower the patient harness bar so that it rests approximately 2 inches above the patient's head. 4. With the harness adjusted to the patient for a tight, comfortable fit, slip the large harness rings onto the safety harness clips at the end of the support rope. To do this, pull on the red tabs to release the clips. Slide the harness rings onto the clips and then lock the clips back in place. 5. Crank Handle #1 on the left side of the unit to raise the patient harness until the red stop indicator bar on the front right side of the top assembly is at the approximate middle of the scale. This mid-scale position for the stop indicator must be maintained. 6. Check the display to see how much weight has been lifted from the patient. Use Handle #2 on the right side of the unit to fine-adjust the weight removed until the display shows the desired level. Ensure that the red stop indicator is still in the middle of the scale. 7. Ensure the patient is comfortable and that the vest is properly fitted. Be sure the shoulder straps do not rub against the patient’s ears. Make sure the bar does not hit the patient’s head. The Unweighing System is now ready for use. NOTE: Handle #1 can be used two different ways. Pull out the handle knob and slide it to the inner position to crank the handle and adjust the crossbar height quickly. Use the outer position to improve your mechanical advantage when assisting the patient to a standing position. USING THE BIODEX UNWEIGHING SYSTEM — 14 — CONTENTS safety tetHer operatioN (Refer to Figure 38.) The Safety Tether is factory installed but a few simple adjustments are required to ensure proper operation during unweighing. The length of the tether strap should equal the length of the harness rope plus four inches when the harness rope is fully extended. Follow the steps below to adjust the safety tether to the correct length. 1. Adjust spreader bar to accommodate patient height. 2. Adjust safety tether strap so that it equals rope length and add four inches. To adjust the strap length, press in on the safety tether release and pull up on the strap to create more slack. Pull down on the free end of the strap to tighten. 3. After adjusting tether length, there may be excess strap length that could interfere with patient. If so, use the clip to adjust the slack strap so it is out of the patient’s way. free WHeeliNg Figure 38. Adjust the Safety Tether The Biodex Unweighing System can be used over the floor so that it is equal in length to the or with other exercise devices. Be aware of the adjustments harness rope, plus four inches. required when moving from one device to another. For example, when stepping down from a treadmill, the stepup height of the treadmill must be taken into account. This is accomplished by rotating Handle #1 and lowering the patient. The opposite is true when going from the floor to the treadmill. When traveling across the floor there is no need to spin the entire unweighing system around when the patient runs out of floor space. Simply turn the patient and head in the opposite direction. ATTENTION: It is best if the steering casters are behind the patient if the therapist will be steering the unit from behind the patient. If the patient will be steering the unit, the steering casters should be in front. JoggiNg The dynamic suspension provides ample dynamics to allow patients to walk briskly or even jog while attached to the unweighing system. ambUlatioN stool (See Figure 39.) The Ambulation Stool can be used to provide a position from which the clinician can easily observe or assist patients with foot placement and weight shifting. To install the stool, hold both stool hinges up (on the underside of the seat) and slide the stool onto the base of the left or right support. Lock the hinges in the down position to secure the stool in place. Figure 39. The Ambulation Stool — 15 — USING THE BIODEX UNWEIGHING SYSTEM 4. MAINTENANCE AND SAFETY INSPECTION cleaNiNg • As needed, wipe down the frame with a solution of warm water and mild detergent. • Hand-wash patient support vest in warm water with mild soap. Air dry. iNspectioN (Refer to Figures 40 - 43.) Although the Biodex Unweighing System is designed for trouble-free operation, simple daily and monthly inspections should be made of the rope to assure patient safety. A more comprehensive inspection should be performed every six months to the pulley assembly to ensure proper operation and safe applications. daily Inspect the Harness Rope and Safety Tether. Lower the harness rope using Handle #1 until the rope is at its maximum length of approximately 50 inches (150cm). The Harness Rope should lower smoothly to its full length. Inspect both rope and safety tether for any signs of wear, which may include: fraying, cuts or kinks. Firmly tug on the rope to assure it is secure. CAUTION: If Harness Rope or Safety Tether show any signs of wear, immediately contact Biodex Customer Service at 1-800-224-6339. Inspect Harness Spreader Bar and clips for signs of wear. Make sure to release clips and lock them into place to ensure they are functioning properly. Rope Inspection Window Inspect the four casters for uneven wear. Ensure they are attached firmly to the Unweighing System. Check that the wheels lock and unlock properly. Harness Rope (length approx. 50") Harness Spreader Bar and Clips monthly Crank the crossbar all the way down while inspecting the entire length of the rope through the Rope Inspection Window. Safety Tether Check All Casters (4 total) Figure 40. Unweighing System daily inspection check-points. MAINTENANCE AND SAFETY INSPECTION — 16 — CONTENTS Every six months the following inspection procedure should be performed to visually examine the entire length of the Harness Rope and Pulley Assembly. You will need a 1/8" Allen Wrench as some disassembly is required. 1. Inspect the harness rope. Lower the harness rope using Handle #1 until it is at its maximum length of 50 inches (150cm). The harness rope should lower smoothly to its full length. Inspect for any signs of wear, which may include fraying, cuts, or kinks in the rope. 2. Remove the Safety Harness and Safety Tether. 3. Remove the Safety Tether routing pins by removing the c-clips with c-clip pliers. 4. Remove the top cross bracket cover secured with 1/8" Allen screws. There are 22 screws total, ten located in front, ten in the back, and two near each upright. Support the bracket cover with your hand as you remove the screws. Once all the screws have been removed, gently pry the bracket cover off. Allen screws Routing Pins Figure 41: Remove all (22) Allen screws that secure the top bracket. Figure 42: Gently pry free the top bracket. 5. Inspect the upper pulley and harness rope for any signs of wear, which may include fraying, cuts, or kinks in the rope . ATTENTION: Should you find any signs of wear or defects in the harness rope or pulley assembly during the inspection, contact Biodex Customer Service immediately at 1-800-224-6339 or 631-924-9000 (international). 6. Replace the three Safety Tether routing pins, Safety Harness and Safety Tether. 7. Replace the cover bracket and screws. 8. Inspect casters and verify that they are attached securely to the Unweighing System. Check that the wheels lock and unlock properly. — 17 — Figure 43: Inspect the upper pulley and harness rope under the top bracket for signs of wear. MAINTENANCE AND SAFETY INSPECTION 5. SPECIFICATIONS • Dimensions: 41.5" w x 50" depth x 106" h (105 x 127 x 270 cm) accommodates patients from pediatric up to 6'11" (210 cm) on a standard treadmill; alternate height setting for facilities with low ceilings: 93.5" h (241 cm) accommodates patients from pediatric up to 6'2" (188 cm) on a standard treadmill • Accommodates Treadmill up to 35" wide • Vertical Adjustment: 60" (152 cm) • Unloading Weight Capacity: 180 lb (82 kg) • Patient Capacity: 500 lb (227 kg) • Operating Temperature Range: 59° to 86° F (15° to 30° C) • Operating Humidity Range: 30% to 75% • Transport/Storage Temperature Range: -4° to 140° F (-20° to 60° C) • Transport/Storage Humidity Range: 20% to 80% non-condensing • Power: 9V Battery • Certification: ETL listed to UL 60601-1 and CAN/CSA C22.2 No.:601-1-M90. CE conformity to IEC 60601-1, EMC compliance to EN 60601-1-2. • Warranty: Two-years parts; one-year labor 0413 Authorized European Community Representative: EC REP Emergo Europe Molenstraat 15 2513 BH, The Hague The Netherlands SPECIFICATIONS — 18 — 8. BIBLIOGRAPHY BARBEAU, H, et al. WALKING AFTER SPINAL CORD INJURY: CONTROL AND RECOVERY Neuro Scientist 4(1): 14-24 / 1998 Biodex #91-119 A NOVEL INTERACTIVE LOCOMOTOR APPROACH USING BODY WEIGHT SUPPORT TO RETRAIN GAIT IN SPASTIC PARETIC SUBJECTS Wernig A (ed) Plasticity of Montoneuronal Connections Amsterdam: Elsevier Science Publishers: 461-474 / 1991 Biodex #91-166* NEW EXPERIMENTAL APPROACHES IN THE TREATMENT OF SPASTIC GAIT DISORDERS Med Sport Sci 36: 234-246 / 1992 Biodex #91-167* BEHRMAN, A L, et al. LOCOMOTOR TRAINING AFTER HUMAN SPINAL CORD INJURY: A SERIES OF CASE STUDIES Physical Therapy: Vol. 80 (7):688-700 / July 2000 Biodex #91-174 BREEN, JC, et al. BODY WEIGHT SUPPORT TREADMILL TRAINING IMPROVES WALKING IN SUB-ACUTE AND CHRONIC SEVERELY DISABLED STROKE PATIENTS Adapted by Mobility Research from a Poster Presentation Biodex #93-119 CHEN, G, et al. TREADMILL TRAINING WITH HARNESS SUPPORT: SELECTION OF PARAMETERS FOR INDIVIDUALS WITH POSTROKE HEMIPARESIS J of Rehabilitation Research & Dev: Vol 43, No. 4: 485-497 Biodex #92-265 da CUNHA, IT, et al. GAIT OUTCOMES AFTER ACUTE STROKE REHABIITATION WITH SUPPORTED TREADMILL AMBULATION TRAINING: A RANDOMIZED CONTROLLED PILOT STUDY Arch Phys Med Rehab, Vol. 83:1258-1265, September 2002 92-238 DeBRUIN, E, et al. CHANGES OF TIBIA BONE PROPERTIES AFTER SPINAL CORD INJURY: EFFECTS OF EARLY INTERVENTION Arch Phys Med Rehabil 80: 214-220 / 1999 Biodex #91-120 DOBKIN, B, et al. RECOVERY OF LOCOMOTOR CONTROL The Neurologist, 2(4): 239-249 / 1996 Biodex #91-168* SENSORY INPUT DURING TREADMILL TRAINING ALTERS RHYTHMIC LOCOMOTOR EMG OUTPUT IN SUBJECTS WITH COMPLETE SPINAL CORD INJURY Proceedings of the Annual Meeting of the Society of Neuroscience Anaheim, CA – 1403, 1992 Biodex #91-169* SCI TRAINING INDUCES RHYTHMIC LOCOMOTOR EMG PATTERNS IN SUBJECTS WITH COMPLETE Neurology, 42 (Supp 3): 207-208 / 1992 Biodex #91-170* MODULATION OF LOCOMOTOR-LIKE EMG ACTIVITY IN SUBJECTS WITH COMPLETE AND INCOMPLETE SPINAL CORD INJURY J. Neuro Rehab – 9(4): 183-190 / 1995 BIBLIOGRAPHY — 19 — 6. OPTIONAL Biodex #91-171 FINCH, L, et al. HEMIPLEGIC GAIT: NEW TREATMENT STRATEGIES Physiotherapist, Canada – 38: 36-41 / 1986 Biodex #91-172 GARD, SA, et al. THE INFLUENCE OF STANCE-PHASE KNEE FLEXION ON THE VERTICAL DISPLACEMENT OF THE TRUNK DURING SPINAL CORD INJURY: A SINGLE SUBJECT EXPERIMENTAL DESIGN Arch Phys Med Rehabil – 80: 26-32 / 1999 Biodex #91-121 GARDNER, M, et al. PARTIAL BODY WEIGHT SUPPORT WITH TREADMILL LOCOMOTION TO IMPROVE GAIT AFTER INCOMPLETE SPINAL CORD INJURY: A SINGLE SUBJECT EXPERIMENTAL DESIGN PT, 78: 361-374 / April 1998 Biodex #91-122 HESSE, S, et al. TREADMILL TRAINING WITH PARTIAL BODYWEIGHT SUPPORT COMPARED WITH PHYSIOTHERAPY IN NON AMBULATORY HEMIPARETIC PATIENTS Stroke 26(6): 976-981 / 1995 Biodex #91-162 TREADMILL WALKING WITH PARTIAL BODY WEIGHT SUPPORT VERSUS FLOOR WALKING IN HEMIPARETIC SUBJECTS Arch Phys Med Rehabil, Vol. 80: 421-427 / April 1999 Biodex #91-123 HODGSON, J, et al. CAN THE AMMALIAN LUMBAR SPINAL CORD LEARN A MOTOR TASK? Med Sci Sports Exerc 26: 1491-1497 / 1994 Biodex #91-173 HUNTER, DL, et al. ENERGY EXPENDITURE OF BELOW THE KNEE AMPUTEES DURING HARNESS SUPPORTED TREADMILL AMUBLATION Platform Presentation – APTA, CSM, 1994 Biodex #91-124 THE EFFECTS OF HARNESS SUPPORT ON LOWER EXTREMITY MUSCLE ACTIVITY OF ABLE BODIED AND TRAUMATIC BRAIN INJURED SUBJECTS DURING GAIT Abstract, PT – 77 / May 1997 Biodex #91-125 MacKAY-LYONS, M, et al. EFFECT OF 15% BODY WEIGHT SUPPORT ON EXERCISE CAPACITY OF ADULTS WITHOUT IMPAIRMENTS Physical Therapy, Vol. 81, No. 11:1790-1800, Nov. 2001 Biodex #92-235 MALOUIN, F, et al. USE OF AN INTENSIVE TASK-ORIENTED GAIT TRAINING PROGRAM IN A SERIES OF PATIENTS WITH ACUTE CEREBROVASCULAR ACCIDENTS Physical Therapy 72(11): 781-793 / 1992 Biodex #91-157 MASSION, J, et al. COORDINATION BETWEEN POSTURE AND MOVEMENT: WHY AND HOW? NIPS, 3: 88-93 / 1988 Biodex #91-175* — 20 — BIBLOGRAPHY CONTENTS MULCARE, JA, et al. PHYSIOLOGICAL RESPONSES DURING UNWEIGHTED AMBULATION: A PILOT STUDY Abstract PT – 78(5) / May 1988 Biodex #91-126 NELSON, AJ, et al. USING THE BIODEX UNWEIGHING SYSTEM, BALANCE SYSEM AND GAIT TRAINER IN AN INTEGRATED REHABILITATION PROGRAM Abstract, May 2001 Biodex #92-217 NORMAN, K, et al. A TREADMILL APPARATUS AND HARNESS SUPPORT FOR EVALUATION AND REHABILITATION OF GAIT Archives Phy Med Rehab – (76): 772-778 / August 1995 Biodex #91-165 SCHINDL, MR, et al. TREADMILL TRAINING WITH PARTIAL BODY WEIGHT SUPPORT IN NONAMBULATORY PATIENTS WITH CEREBRAL PALSY Arch Phys Med Rehabil March 2000, Vol. 81:301-206 Biodex #91-181 SIMPSON, S, et al. UNLOADED TREADMILL TRAINING THERAPY FOR LUMBAR DISC HERNIATION INJURY J Athletic Training, Vol. 31(1):57-60 / March 1996 Biodex #91-128 STEFFEN, TM, et al. LONG-TERM LOCOMOTOR TRAINING FOR GAIT AND BALANCE IN A PATIENT WITH MIXED PROGRESSIVE SUPRANUCLEAR PALSY AND CORTICOBASAL DEGENERATION Physical Therapy: Vol. 87, No. 8, 1078-1087 Biodex #92-273 SULLIVAN, KJ, et al. STEP TRAINING WITH BODY WEIGHT SUPPORT: EFFECT OF TREADMILL SPEED AND PRACTICE PARADIGMS ON POSTSTROKE LOCOMOTOR RECOVERY Arch Phys Med Rehabil, Vol. 83, May 2002 - 683-691 Biodex #92-242 SVENDSEN, B TREATMENT OF THE HEMIPLEGIC PATIENT: NEW STRATEGIES FOR GAIT TRAINING Phys Ther Prod: 32-34 / March 1996 Biodex #91-129 VAN EMMERIK, R, et al. IDENTIFICATION OF AXIAL RIGIDITY DURING LOCOMOTION IN PARKINSON’S DISEASE Arch Phys Med Rehab – 80: 198-191 / 1999 Biodex #91-131 VISINTIN, M, et al. A NEW APPROACH TO RETAIN GAIT IN STROKE PATIENTS THROUGH BODY WEIGHT SUPPORT AND TREADMILL STIMULATION Stroke – 29: 1122-1128 / 1998 Biodex #91-130 WERNIG, A, et al. IMPROVEMENT OF WALKING IN A SPINAL CORD INJURED PERSON AFTER TREADMILL TRAINING In: Wernig A (ed.) Plasticity of Motoneuronal Connections Amsterdam: Elsevier Science Publishers: 475-485 / 1991 Biodex #91-176* Rev: December 7, 2007 BIBLOGRAPHY — 21 — 9. ELECTROMAGNETIC COMPATIBILTY conformance to standards This equipment conforms to the following safety standards: standard Edition and/or date IEC60601-1-2 First edition, 2007 Table 1.1 Safety standards accompanying emc documents This medical electrical equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in this manual. • Portable and mobile RF communications equipment can affect medical electrical equipment. • Use of accessories, transducers and cables other than those specified, with the ex¬ception of accessories, 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 Unweighing System should not be used adjacent to or stacked with other equipment. If the Unweighing System 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 There are no accessory cables supplied with the Unweighing System for which the manufacturer of this equipment claims compliance to EN 60601-1-2 when used with the Unweighing System. — 22 — ELECTROMAGNETIC COMPATIBILITY CONTENTS declaration of conformity immunity Manufacturer’s d declaration eclla electromagn Manufacturer’s aration electromagnetic netic immunity immunity use in in the the electromagnetic electromagnetic environment The Unweighing Unweighing System environment specified speciffiied below. The S ystem is in intended tended for for use below. The The customer customer or or the the user user of of the Unweighing weighing System S ystem sh should that at it such an an environment. environment. the Un ould assure assure th it is is used used in such El Immunity Immu nity test test Electromagnetic ectromag gn netic environment environment – g guidance uidance IEC 60601-1-2 IEC 60601-1-2 IEC 6 0601-1-2 IE C6 0601-1-2 Test Test llevel evel Compliance Co mplliiance level lleevel El Electrostatic ectrosttaatic discharge discharge ±6k kV V contact contact Contact Co ntact ± 6 kV kV should wood, concrete ceramic Floor hou uld be wood, conccrete or ceramic Floor sh (ESD) ir Ai kV V (ESD) ± 8 kV aair Airr ± 8 k tiles. If fflo floor loor is is covered covered with with synthetic sy yn nthetic tiles. If IEC 61000-4-2 IEC 6 1000 -4-2 material, ma aterriial, the the relative relative humidity humiditty y should should be be at at least least 30% ELECTROMAGNETIC COMPATIBILITY — 23 — CONTENTS Immunity Immu nity test test Po Power wer ffrequency r eq uency (5 (50/60 0/60 H Hz) z) m magnetic agnettic fi eld field IE C6 1000 -4-8 IEC 61000-4-8 Radiated RF RF Radiated IEC 61000-4-3 61000-4-3 IEC IEC IEC 6 60601-1-2 0601-1-2 Te Test st llevel evel 3 A/m A/ m IEC IEC 6 60601-1-2 0601-1-2 Compliance Co mplliiance level lleevel 3 A/m A/ m 3 V/m, V / m, 80 M MHz GHz H z tto2.5 o 2 .5 G Hz 3 V/m, V / m, 80 M MHz GHz H z tto2.5 o 2 .5 G Hz El Electromagnetic ectromag gn netic environment environment – g guidance uidance If image image distortion distortion occurs, occurs, it it may may be b e necessary necessar y disp lay to p position osition the the Unweighing Unweighing System S ystem display equency from sources sources of of power power fr further fu rrtther from frequency shielding. magnetic magnetic fields ffiields or to to iinstall nstall magnetic magnetic shielding. should be be Th power frequency magnetic field Thee power ffrrequency magnetic ffiield should to measured measured in in the the intended intended installation location to instaalllation location assure that low assure that it it is sufficiently sufffiiciently low Portable Porttaable and and mobile mobile RF RF communications communications equipment should should be be used used no no closer equipment closer to to any any pa part arrtt the Unweighing Unweighing System, S ystem, iincluding of the ncluding cables, cables, distance than th an the the recommended recommended separation separation distance cal culaated from the the equation t n applicable calculated ffrrom the equatio applicable to the frequency frequency of the the transmitter. transmitter. Recommended Recommended separation separation distance: distance: d=1 . 2! P 1 5 0 KHz KH z to 8 0M Hz 1.2! 150 80 MHz d=1 .2! P 80 MH 00 M Hz 1.2! MHzz to 8 800 MHz d=2 .3! P 80 0 MHz MHz to 2. 5 GHz G Hz 2.3! 800 2.5 where where P is is tthe he maximum maximum output output power power rating rating of the transmitter transmitter in watt watt (W) (W) according according to th the thee and d is the tr transmitter ansmitter manufacturer, manufactur er, and the in meters meters recommended recommended separation separation distance distance in (m). (m) . Field Field strengths strengths from ffrrom fixed ffiixed RF RF transmitters, transm mitttters, aass determined de ter mined by b y an an electromagnetic electromagnetic site site survey surveya, co mp liance level level in sh should ould be b e lless ess than than the the compliance rangeb. each frequency ffrrequency range of In Interference terference may ma y occur occur in in the the vicinity vicinit y of equipment equ uipment marked marked with with the the following following symbol: sy ym mbol: No Note te 1 1.. UT UT is is tthe he a.c. a.c. mains mains voltage vo ltage prior prior to to application application of of the the test test level. level. No te 2 0 MHz MHz aand Note 2.. A Att 8 80 nd 800 800 MHz, MHz, tthe he higher higher frequency ffrr equency range range applies. aap pplies. Note guidelines may not not apply apply in in all all situations. sittu uations. Electromagnetic Electromagnetic propagation is affected affected by b y absorption absorrp ption and and reflections reffllections Note 3. 3 . These These g uidelines may propagation is people fr from om structures, structtu ur es, o objects bjects and and people a telephones and radio, AM such as as base base stations Field Field strength strength from from mixed mixed transmitters, tr ansmitters, such stations for for radio radio telephones and land land mobile mobile radios, r adios, amateur amateur radio, due be predicted predicted theoretically with accuracy. accuracy. To or FM FM b broadcast roadcast and and T TV V broadcast broadcast cannot cannot be theoretically with To assess assess the the electromagnetic electromagnetic environment environment due location in in to ffi fixed ixed RF RF transmitters, transmitters, an an electromagnetic electromagnetic site site survey survey should should be be considered. considered. If If the the measured measured field ffiield strength strength in in th thee location wh ich the the Unweighing Unweighing System S ystem is u sed exceeds exceeds the the applicable applicable RF levels above, above, the the Unweighing Unweighing System S ystem sh ould be be which used RF compliance compliance levels should ob observed served to to v verify eriffy y normal mal operation. operation. If If abnormal abnorrm mal performance is observed, obserrv ved, additional additional measures measures may may be be necessary, necessary, such norrm performance is such as as reorienting reorientting the Unweighing or relocating relocating the Unwe weighing System. S ystem. b 150 KHz KHz tto Over Over tthe he frequency frequency range r ange 150 o8 80 0M MHz, Hz, field field sstrengths trengths should should be be less less than than 3 V/m. V//m. — 24 — ELECTROMAGNETIC COMPATIBILITY CONTENTS recommended separation distances Re Recommended commended separation seep paratiio on distances distances between bettw ween portable portabllee and and mobile mobile RF RF communications communications equipment equipment and and the the Unweighing Un weighin g Sy System. steem. Ta Table ble 6 Th S ystem is in Thee Un Unweighing weighing System intended tended for for use use in the the electromagnetic electromagnetic environment enviirronment in which which radiated radiated RF RF disturbance disturbance are are The cu S ystem can help help prevent prevent electromagnetic electromagnetic interference by co controlled. ntrolled. The customer stomer or or the the user user of of the the Unweighing Unweighing System interference by equipment (transmitters) minimum distance maintaining ma aintaining a minimum disttaance be between ttw ween portable porrttable and and mobile mobile RF RF communication communication equipment (ttransmitters) and and the the Un Unweighing weighing S System ystem as rrecommended o the the maximum maximum output of the the communication communicattion equipment. ecommended below, below, according according tto output power power of equip ment. Rated Rated maximum maximum output outtp p ut Separation Se eparattiion d distance according to to frequency frequency of of transmitter transmitter [m] [m] istance according power power o off transmitter transmitter [[W] W] 15 150 0 kHz kHz to to 80 MHz MHz 80 MHz MHz tto o 800 MHz MHz 80 800 0 MHz MHz tto o 2.5 2.5 G GHz Hz d=1 .2 ! P d=1 .2 ! P d=2 .3 ! P 1.2! 1.2! 2.3! 0.01 0.01 0.12 0.12 0.23 0. 12 0. 12 0. 23 0.1 0.1 0. 38 0.38 0. 38 0.38 0. 73 0.73 1 1.2 1. 2 1.2 1. 2 2.3 2. 3 10 3. 8 3.8 3. 8 3.8 7. 3 7.3 100 12 12 23 power not not listed r ecommended separation For For ttransmitters ransmitttters rated rated at at a maximum maximum output output power listed above, above, the the recommended separation distance distance d in m meters eters (m) (m) can can using the the equation power be estimated estimated using equation applicable applicable to to the the frequency frequency of the the transmitter, transmitter, where where P is is the the maximum maximum output output power rating ra ating of tthe he transmitter transmitttter in in watts watts (W) ( W) according according to to the the transmitter transmitter manufacturer. manuffacttu urer. No te 1 separattion distance Note 1.. At At 8 80 0M MHz Hz and and 8 800 00 M MHz, Hz, tthe he separation distance for for the the higher higher frequency frequency range r ange applies. applies. Note 2. 2 . These These g uidelines may Note guidelines may not not apply apply in in all all situations. sittu uations. Electromagnetic Electromagn netic propagation propagation is is affected affected by b y absorption absorption and and reflection reffllection people. fr from om structures, structtu ures, objects objects and 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). ELECTROMAGNETIC COMPATIBILITY — 25 — 10. REPLACEMENT REPLACEMENT — 26 — 8. REPLACEMENT — 27 — REPLACEMENT CONTENTS REPLACEMENT — 28 — CONTENTS — 29 — REPLACEMENT CONTENTS REPLACEMENT — 30 — CONTENTS — 31 — REPLACEMENT CONTENTS REPLACEMENT — 32 — CONTENTS — 33 — REPLACEMENT CONTENTS CONTENTS — 34 — 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: [email protected], www.biodex.com