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UNWEIGHING SYSTEMINSTALLATION/ OPERATION MANUAL945-480
BIODEXBiodex 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 D 6/16
UNWEIGHING SYSTEM
This manual covers installation and operation procedures for the following Biodex product:
#945-480 Unweighing System
Authorized European Community Representative:
Emergo EuropeMolenstraat 152513 BH, The HagueThe Netherlands
— II —
EC REP
TABLE OF CONTENTS
— III — 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...................................................................................................................................
DEFINITION OF SYMBOLS — IV —
DEFINITION OF SYMBOLS
Biodex Medical Systems, Inc. © 2012
D The following symbols and their associated definitions are used and implied throughout this manual. SSyymmbbooll DDeeffiinniittiioonn
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
CE Mark
Certified for Safety by ETL Intertek
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rewoff” P“O
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— V — 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 appro-priate treatment techniques. Each subject’s unique situation should be taken into accountbefore beginning any type of testing or rehabilitation program. Be sure you fully comprehendthe operating instructions, as well as the considerations, both physical and clinical, discussedthroughout the manual before attempting to set up a subject for testing or exercise. Practicesetups 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 orrepair 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 autoriséedu 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 conductedto ensure continued safe use of equipment.
AvERTIssEmENT: Si cet équipement est inspection modifiée, appropriée et essais doivent êtreeffectués 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]
BEFORE PROCEEDING
IMPORTANT SAFETY INFORMATION
IMPORTANT SAFETY INFORMATION — VI —
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 606 01-1-2.
"ON" (Power)
Caution
Date of Manufacture
CE Mark
Type B applied part
Kg KilogramLb Pound
Follow the unpacking and assembly instructions document.
Before using this device, read the entire operation manual carefully. Failure to read the manual mayresult 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 Proceedingsection 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 beinstalled 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.
0413
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 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 equipmentfound 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 FITNESSFOR USE. BIODEX DOES NOT ASSUME LIABILITY FOR INCIDENTAL, CONSEQUENTIALOR INDIRECT DAMAGES INCLUDING LOSS OF USE, SALES, PROFITS OR BUSINESSINTERRUPTION.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 thana BIODEX MEDICAL SYSTEMS, INC. authorized repair and calibration facility. Misuse andabuse include, but are not limited to, subjecting limits and allowing the equipment to becomecontaminated by radioactive materials.C. In order to obtain warranty repair service, the equipment or system component must bereturned 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 systemcomponent will be returned transportation prepaid.
2. calibration
A. Instruments are warranted to be within their specified accuracy at the time of shipment. If aquestion arises and BIODEX MEDICAL SYSTEMS, INC. determines that the initial calibration isin error, the instrument will be recalibrated at no charge.B. Mechanical products are warranted to meet written specifications and tolerances at the timeof 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 BIODEXMEDICAL SYSTEMS, INC. at a factory authorized service location. Estimates of repair chargesmay be requested, however, a charge for estimate preparation may apply if the repair is later notauthorized by the customer.B. The cost of transportation into and out of the service location will be the responsibility of thecustomer.
UNWEIGHING SYSTEM WARRANTY
— VII — WARRANTY
service procedureIf 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 backto you. Be sure to let the service representative know your schedule so that we can call at aconvenient 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 informationBiodex 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
CONTENTS
WARRANTY — VIII —
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 neurolog-
ical 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 when-
ever gait therapy is prescribed for patients who are unable to support their own body weight or
1. INTRODUCTION
— 1 — INTRODUCTION
Attachment rings - on support vest allow single or two-point pelvic stabilization when desired
Unweighing Harness fits avariety of patients
Two position handle foreasy and efficient patientunloading
Accommodates childrenand adults
Real time digitalscale displays off-loaded weight inpounds or kilograms
Patented off-loadingmechanism maintainsconstant force
Simply dial inamount to offload
Adjust to fit 8' ceilings
Large locking castersfor effortless mobilityover ground
Dynamic suspensionallows for naturalvertical displacementof center of gravity
Offset frame designoffers improved accessto manually assistpatient footfall andweight shift
Removable Therapist seats provide a place to sitduring assistive exercise and provides a saferenvironment for therapist interaction
Removable and adjustablepatient handrails
If pelvic stabilization is required,the Biodex Unweighing Systemincludes Pelvic StabilizationStraps to govern thedegree ofpelvic rotation.Stabilizationstraps aremade of Thera-Band® andadjustable nylon hooks.
Single point suspension permits functional pelvic rotation and versatility whenwalking, side-stepping, retro-walking and turning
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 car-
diovascular 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) aswell as bone and muscle integrity (in chronic cases).
With the patient supported by the suspension system, horizontal movement is provided by set-
ting 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 tread-
mill speed and/or the amount of weight borne by the patient can be gradually increased to bet-
ter 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 suspen-
sion 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 walk-
ing patterns is the most essential element to the success of this therapy, be sure to provide con-
sistent training without interruptions or breaks.
Patients are evaluated over a two-week period and are expected to make some gains in their abil-
ity 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.
CONTENTS
INTRODUCTION — 2 —
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 cor-
rect 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 benefi-
cial 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 specifica-
tions. 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 dur-
ing 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 pat-
tern (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 sys-
tem 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 coordina-
tion 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 act-
ing 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 uti-
lization 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 —
CONTENTS
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 theunweighing system will be assembled on a level surface. Ensure that there is enough room to moveeasily around the unweighing system frame during installation.
Au moins deux personnes sont tenues d'accomplir la procédure suivante. Garantissez que le système nonpesant sera rassemblé sur une surface de niveau. Garantissez qu'il y a assez de pièce pour bouger facilementautour 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 mustselect the same hole setting for each side. Height should be determined by ceiling height of the area wherethe unit will be used. Be aware of exit signs, lights, fire sprinklers, etc. For the 8’5” and 9’ settings, use thesupplied 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
2. ASSEMBLY INSTRUCTIONS
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 legson the floor next to the top frame assembly.
Figure 3. Slide the Top Frame Assemblyinto the support legs.
Figure 4. Insert patient support handles into thehandrail receiving tubes.
Figure 5. Attach the Safety Harness.
ASSEMBLY INSTRUCTIONS — 6 —
CONTENTS
— 7 — USING THE BIODEX UNWEIGHING SYSTEM
ATTENTION: Never leave a patient unattended on this device. Check all cables, harnesses andfittings before each use. See Chapter 4, “Maintenance and Safety Inspection,” for additionalinstructions.
ATTENTION: The Biodex Unweighing System uses a special harness to support the patient. It isvital that the harness fits properly on the patient. Refer to the Biodex Standard Unweighing HarnessOperation 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 shouldbe 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.
3. USING THE BIODEX UNWEIGHING SYSTEM
determiNatioN of body WeigHt sUpport
Heel/g round 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 involve-
ment 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.
CONTENTS
USING THE BIODEX UNWEIGHING SYSTEM — 8 —
Figure 6.The Biodex Unweighing Systempositioning for use with theBiodex RTM Treadmill.
Figure 7.The Biodex Unweighing System
positioning for use with theBiodex Balance System.
Figure 8.The Biodex Unweighing Systemready for free wheeling.
X
— 9 — USING THE BIODEX UNWEIGHING SYSTEM
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 extend-
ed 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 wrapand apply it low across the hipsin the area that the harness willeventually rest. Apply a moder-ate amount of tension on thewrap so that it will not slip onitself during use. This wrap pre-vents sliding of the harnessproximally while unloading.
Figure 10. Take the remainingfasten straps and fasten to thewrap.
Figure 11. The bottom of thewrap should rest between thegreater trochanter and theASIS.
Figure 12. Begin to apply theharness. While standing makesure the “O” rings on the harness shoulder straps fallaround the level of the ears.This can be accomplished byraising or lowering the over-head bar of the BiodexUnweighing System.
Figure 13. Adjust the shoulderharness straps length, which inturn adjusts the height of theharness. The bottom of the har-ness should be adjusted to thelower edge of the neopreneunder wrap.
Figure 14. Adjust the backstraps on the vest so that theanterior buckle (picture 7)falls near the greatertrochanter.
CONTENTS
USING THE BIODEX UNWEIGHING SYSTEM — 10 —
Figure 15. Tighten the frontstraps to a moderate tensionso that the vest feels secure tothe patient.
Figure 16. Notice how the anterior buckle is resting nearthe greater trochanter. Alsonotice how the lower edge ofthe harness falls close to thelower edge of the neopreneunderwrap.
Figure 17. Using the coloreddots as a guide, fasten the posterior buckle of the glutealfold strap.
Figure 18. Take the remainingbuckle (anterior strap) andbring it through the inside ofthe leg and fasten it to the anterior buckle.
Figure 19. Next, fasten thethigh cuff (the thigh cuffshould not be too tight, it isprimarily there to hold thegluteal fold strap in place).
Figure 20. Tension the glutealfold strap until it is snugunder the gluteals.
CONTENTS
— 11 — USING THE BIODEX UNWEIGHING SYSTEM
Figure 24. Fasten the thighcuff.
Figure 25. A completed anteri-or view of proper vest place-ment.
Figure 21. Notice, when proper-ly fitted, the anterior buckletilts forward and allows theanterior strap to ride aroundthe inside of the leg and not upinto the crotch.
Figure 22. Now is the time toapply the opposite side glutealfold strap. Insert the posteriorstrap into the posterior bucklewith the color-coded dots.
Figure 23. Fasten the anteriorbuckle by bringing it alongthe inside of the leg.
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.
USING THE BIODEX UNWEIGHING SYSTEM — 12 —
CONTENTS
Figure 26. Attach the left andright posterior straps to theposterior buckles, also colorcoded.
Figure 27. A completed lookafter the posterior straps arein place.
Figure 28. Bring the strap-ping system through the legsand place the color-codedstrap into the correspondingcolor-coded anterior buckle.
Figure 29. Do the same on theopposite side.
Figure 30. Completed look ofinguinal strapping system inplace.
prone Harness fixation
(See Figures 31-33.)
other features
(See Figures 34-36.)
CONTENTS
— 13 — USING THE BIODEX UNWEIGHING SYSTEM
Figure 34. Release Tab. Torelease the patient from theUnweighing System withoutremoving the harness, simplypull on the red tab. Make sureboth you and the patient areprepared for this as the systemwill no longer support thepatient’s load after the clampis released.
Figure 35. Side handles. Usedto stabilize the patient's trunkor guide them laterally ineither direction.
Figure 36. Strapping ring.Used to load the patientlaterally and to stabilize orprevent excessive trunkrotation.
Figure 31. To apply the har-ness while supine, first lay theharness on a table or plinthlow enough to transfer thepatient.
Figure 32. Apply the underwrap as mentioned above andseat the patient below the har-ness. Please make sure thepatient is seated so the bottomedge of the wrap aligns withthe bottom edge of the harnesswhen you lay them down.
Figure 33. Lay the patientdown on the harness andrepeat the previously men-tioned steps depending onyour application.
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 pres-sure on the patient’s abdominal area, including the bladder. Should a harness become soiled, it canbe 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 hospitalrequirements of an eight-time load rating. The device is rated for use withpatients 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.
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 <ON> 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 innerposition 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.
CONTENTS
USING THE BIODEX UNWEIGHING SYSTEM — 14 —
Figure 37.
CONTENTS
— 15 — USING THE BIODEX UNWEIGHING SYSTEM
safety tetHer operatioN
(Refer to Figure 38.)
The Safety Tether is factory installed but a few simple adjust-
ments 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
The Biodex Unweighing System can be used over the floor
or with other exercise devices. Be aware of the adjustments
required when moving from one device to another. For
example, when stepping down from a treadmill, the step-
up 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 steer-ing the unit from behind the patient. If the patient will be steering the unit, the steering castersshould 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 posi-
tion 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
Figure 38. Adjust the Safety Tether so that it is equal in length to the harness rope, plus four inches.
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 compre-
hensive 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 BiodexCustomer 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.
Inspect the four casters for
uneven wear. Ensure they are
attached firmly to the
Unweighing System. Check
that the wheels lock and
unlock properly.
monthly
Crank the crossbar all the way
down while inspecting the
entire length of the rope
through the Rope Inspection
Window.
Figure 40. Unweighing System daily inspection check-points.
MAINTENANCE AND SAFETY INSPECTION — 16 —
4. MAINTENANCE AND SAFETY INSPECTION
Check All Casters (4 total)
HarnessSpreader Barand Clips
Harness Rope (length approx. 50")
Safety Tether
Rope Inspection Window
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.
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 inthe harness rope or pulley assembly during the inspection, contactBiodex 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 — MAINTENANCE AND SAFETY INSPECTION
CONTENTS
Figure 42: Gently pry free the top bracket. Figure 41: Remove all (22) Allen screwsthat secure the top bracket.
Routing Pins
Allen screws
Figure 43: Inspect theupper pulley and harness ropeunder the top bracket for signsof wear.
• Dimensions: 49" w x 50" depth x 104" h (124 x 127 x 264 cm) accommodates patients from pediatric
up to 6'11" (210 cm) on a standard treadmill; alternate height setting for facilities with low ceilings:
94" (239 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 EN 60601-1, EMC compliance to IEC 60601-1-2.
• Warranty: Two-years parts; one-year labor
Authorized European Community Representative:
Emergo EuropeMolenstraat 152513 BH, The HagueThe Netherlands
SPECIFICATIONS — 18 —
5. SPECIFICATIONS
0413
EC REP
BARBEAU, H, et al.WALKING AFTER SPINAL CORD INJURY: CONTROL AND RECOVERY
Neuro Scientist 4(1): 14-24 / 1998Biodex #91-119
A NOVEL INTERACTIVE LOCOMOTOR APPROACH USING BODY WEIGHT SUPPORT TO RETRAIN GAIT IN SPASTIC PARETIC SUBJECTS
Wernig A (ed) Plasticity of Montoneuronal ConnectionsAmsterdam: Elsevier Science Publishers: 461-474 / 1991Biodex #91-166*
NEW EXPERIMENTAL APPROACHES IN THE TREATMENT OF SPASTIC GAIT DISORDERSMed Sport Sci 36: 234-246 / 1992Biodex #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 2000Biodex #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 PresentationBiodex #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: 485-497Biodex #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 200292-238
DeBRUIN, E, et al.CHANGES OF TIBIA BONE PROPERTIES AFTER SPINAL CORD INJURY:EFFECTS OF EARLY INTERVENTION
Arch Phys Med Rehabil 80: 214-220 / 1999Biodex #91-120
DOBKIN, B, et al.RECOVERY OF LOCOMOTOR CONTROL
The Neurologist, 2(4): 239-249 / 1996Biodex #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 NeuroscienceAnaheim, CA – 1403, 1992Biodex #91-169*
TRAINING INDUCES RHYTHMIC LOCOMOTOR EMG PATTERNS IN SUBJECTS WITH COMPLETE SCINeurology, 42 (Supp 3): 207-208 / 1992Biodex #91-170*
MODULATION OF LOCOMOTOR-LIKE EMG ACTIVITY IN SUBJECTS WITH COMPLETE ANDINCOMPLETE SPINAL CORD INJURY
J. Neuro Rehab – 9(4): 183-190 / 1995Biodex #91-171
8. BIBLIOGRAPHY
BIBLIOGRAPHY — 19 —
FINCH, L, et al.HEMIPLEGIC GAIT: NEW TREATMENT STRATEGIES
Physiotherapist, Canada – 38: 36-41 / 1986Biodex #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 / 1999Biodex #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 1998Biodex #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 / 1995Biodex #91-162
TREADMILL WALKING WITH PARTIAL BODY WEIGHT SUPPORT VERSUS FLOOR WALKING INHEMIPARETIC SUBJECTSArch Phys Med Rehabil, Vol. 80: 421-427 / April 1999Biodex #91-123
HODGSON, J, et al.CAN THE AMMALIAN LUMBAR SPINAL CORD LEARN A MOTOR TASK?
Med Sci Sports Exerc 26: 1491-1497 / 1994Biodex #91-173
HUNTER, DL, et al.ENERGY EXPENDITURE OF BELOW THE KNEE AMPUTEES DURING HARNESS SUPPORTED TREADMILL AMUBLATION
Platform Presentation – APTA, CSM, 1994Biodex #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 1997Biodex #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. 2001Biodex #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 / 1992Biodex #91-157
MASSION, J, et al.COORDINATION BETWEEN POSTURE AND MOVEMENT: WHY AND HOW?
NIPS, 3: 88-93 / 1988Biodex #91-175*
6. OPTIONAL
— 20 — BIBLOGRAPHY
Rev: December 7, 2007
BIBLOGRAPHY — 21 —
CONTENTS
MULCARE, JA, et al.PHYSIOLOGICAL RESPONSES DURING UNWEIGHTED AMBULATION: A PILOT STUDY
Abstract PT – 78(5) / May 1988Biodex #91-126
NELSON, AJ, et al.USING THE BIODEX UNWEIGHING SYSTEM, BALANCE SYSEM AND GAIT TRAINER IN ANINTEGRATED REHABILITATION PROGRAM
Abstract, May 2001Biodex #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 1995Biodex #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. 81:301-206Biodex #91-181
SIMPSON, S, et al.UNLOADED TREADMILL TRAINING THERAPY FOR LUMBAR DISC HERNIATION INJURY
J Athletic Training, Vol. 31(1):57-60 / March 1996Biodex #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, 1078-1087Biodex #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 - 683-691Biodex #92-242
SVENDSEN, BTREATMENT OF THE HEMIPLEGIC PATIENT: NEW STRATEGIES FOR GAIT TRAINING
Phys Ther Prod: 32-34 / March 1996Biodex #91-129
VAN EMMERIK, R, et al.IDENTIFICATION OF AXIAL RIGIDITY DURING LOCOMOTION IN PARKINSON’S DISEASE
Arch Phys Med Rehab – 80: 198-191 / 1999Biodex #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 / 1998Biodex #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 ConnectionsAmsterdam: Elsevier Science Publishers: 475-485 / 1991Biodex #91-176*
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 beinstalled 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 replacementparts for internal and external components, may result in increased emissions or decreasedimmunity of the equipment.
• The Unweighing System should not be used adjacent to or stacked with other equipment. If theUnweighing System is used while positioned adjacent to other equipment, it should beobserved 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 manufacturerof this equipment claims compliance to EN 60601-1-2 when used with the Unweighing System.
9. ELECTROMAGNETIC COMPATIBILTY
— 22 — ELECTROMAGNETIC COMPATIBILITY
declaration of conformity
immunity
CONTENTS
ELECTROMAGNETIC COMPATIBILITY — 23 —
Manufacturer’s declaration electromagnetic immunity The Unweighing System is intended for use in the electromagnetic environment specified below. The customer or the user of the Unweighing System should assure that it is used in such an environment. Immunity test IEC 60601-1-2
Test level IEC 60601-1-2 Compliance level
Electromagnetic environment – guidance
Electrostatic discharge (ESD) IEC 61000-4-2
± 6 kV contact ± 8 kV air
Contact ± 6 kV Air ± 8 kV
Floor should be wood, concrete or ceramic tiles. If floor is covered with synthetic material, the relative humidity should be at least 30%
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— 24 — ELECTROMAGNETIC COMPATIBILITY
Immunity test IEC 60601-1-2 Test level
IEC 60601-1-2 Compliance level
Electromagnetic environment – guidance
Power frequency (50/60 Hz) magnetic field IEC 61000-4-8
3 A/m 3 A/m If image distortion occurs, it may be necessary to position the Unweighing System display further from sources of power frequency magnetic fields or to install magnetic shielding. The power frequency magnetic field should be measured in the intended installation location to assure that it is sufficiently low
Radiated RF IEC 61000-4-3
3 V/m, 80 MHz to2.5 GHz
3 V/m, 80 MHz to2.5 GHz
Portable and mobile RF communications equipment should be used no closer to any part of the Unweighing System, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance: d = 1.2! P 150 KHz to 80 MHz d = 1.2! P 80 MHz to 800 MHz d = 2.3! P 800 MHz to 2.5 GHz where P is the maximum output power rating of the transmitter in watt (W) according to the transmitter manufacturer, and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site surveya, should be less than the compliance level in each frequency rangeb. Interference may occur in the vicinity of equipment marked with the following symbol:
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
a 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 transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Unweighing System is used exceeds the applicable RF compliance levels above, the Unweighing System should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Unweighing System. b Over the frequency range 150 KHz to 80 MHz, field strengths should be less than 3 V/m.
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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).
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ELECTROMAGNETIC COMPATIBILITY — 25 —
Recommended separation distances between portable and mobile RF communications equipment and the Unweighing System. Table 6 The Unweighing System is intended for use in the electromagnetic environment in which radiated RF disturbance are controlled. The customer or the user of the Unweighing System can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communication equipment (transmitters) and the Unweighing System as recommended below, according to the maximum output power of the communication equipment.
Separation distance according to frequency of transmitter [m] Rated maximum output power of transmitter [W] 150 kHz to 80 MHz
d = 1.2! P 80 MHz to 800 MHz d = 1.2! P
800 MHz to 2.5 GHz d = 2.3! P
0.01 0.12 0.12 0.23 0.1 0.38 0.38 0.73 1 1.2 1.2 2.3 10 3.8 3.8 7.3 100 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 applicable to the frequency of the transmitter, 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 absorption and reflection from structures, objects and people.
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10. REPLACEMENT
REPLACEMENT — 26 —
8. REPLACEMENT
— 27 — REPLACEMENT
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REPLACEMENT — 28 —
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REPLACEMENT — 30 —
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— 31 — REPLACEMENT
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REPLACEMENT — 32 —
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— 33 — REPLACEMENT
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BIODEXBiodex 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
