System 4 Instructions for Use Rev C Feb 2022

SYSTEM 4 This instructions for use document covers safe operation of the three System 4 dynamometer models. All three models have the same performance characteristics. The differences among the three models are based on the chair and dynamometer adjustments on the T-Base. • • •

850-000 System 4 Pro – Adjustable height chair, movable chair and dynamometer. 840-000 System 4 Quick-Set – Fixed height chair adjusts its position on the T-Base. Has a fixed dynamometer position relative to the T-Base. 852-000 System 4 MVP – Fixed height chair similar to the Quick-Set.

Additional information and resources, including installation instructions, are available upon request or directly from the Biodex website, http://www.biodex.com. If the desired information is not found, please feel free to contact a local distributor or Biodex directly at supportservices@biodex.com Thank you, Biodex Medical Systems, Inc.

Contact Information Manufactured by: Biodex Medical Systems, Inc. (Part of Mirion Technologies) 20 Ramsey Road, Shirley, New York, USA 11967-4704 Tel: 800-224-6339 (Int’l 631-924-9000) Fax: 631-924-8355 email: supportservices@biodex.com www.biodex.com

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Table of Contents Important Safety Information ... 9 1. Introduction ... 10 2. Getting Started ... 11 Controls and Adjustments ... 11 Dynamometer ... 11 Positioning Chair ... 14 Seat Back Brace... 16 The Controller ... 17 Readying the System for Use ... 18 Dynamometer Attachments ... 19 Using the Combination Ankle Attachment ... 21 Adjusting the Footplate ... 22 Shutting Down the System at the End of the Day ... 23 Regional Settings ... 23 Modes of Operation ... 24 Additional Considerations ... 27 Proper Testing Technique ... 28 Set Up and Positioning Videos... 28 3. Software Operation... 29 Getting Started ... 30 Home Screen ... 31 Connection Status... 31 Introduction: New Software ... 32 Tips for Using Biodex Advantage BX™ Software ... 32 Protocol Based Activity... 33 Defining ROM ... 42 Protocol Based Activity Screen ... 45 Practice Reps with Activity ... 51 Activity Results ... 59 Linked Protocols ... 63 Training Setup ... 69 Training... 71 Reports... 73 Return to Play ... 79 Goal Management ... 80 Hamstring Injury Reports ... 93 3

Curve Analysis ... 103 Dynamometer Status ... 123 Utilities ... 124 Patient Management ... 124 Protocol Management ... 125 Data Management... 129 Application Settings ... 141 System Settings ... 149 Facility Info and Logo... 153 4. Clinical Education ... 154 5. Software Updates ... 154 6. Maintenance ... 155 Cleaning Instructions ... 155 Hardware ... 155 Verify Calibration ... 155 Disposal ... 156 7. Definition of Terms ... 157 8. Specifications and Certifications ... 160

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Definition of Symbols The following symbols and their associated definitions are used and implied throughout this manual.

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Product Certifications and Classifications This product has received the following certifications and falls within the following classifications: • IEC 60601-1:2005 (Third Edition) + CORR. 1:2006 + CORR. 2:2007 + A1:2012 (or IEC 60601-1: 2012 reprint) • ANSI/AAMI ES60601-1:2005+A1:2012+C1:2009+A2:2010. • CAN/CSA C22.2 No. 60601-1:14 • FDA Class II Equipment •

Type B Applied Part

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Electromagnetic Compatibility: This equipment complies with the Medical Equipment IEC 60601-1-2:2014 EMC Standard.

NOTE: Component part lists, descriptions, calibration instructions, or other information used to assist service personnel to repair those parts of the equipment that are designated as repairable for this product are provided on the Biodex website, www.biodex.com or can be obtained by contacting Biodex Customer Service (see Contact information). NOTE: Complete information on the Electromagnetic Compatibility for the System 4 can be located in the Compliance Supplement located on the Biodex website (www.biodex.com) or can be obtained by contacting Biodex Customer Service (see Contact information). Authorized European Community Representative:

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Cautions NOTE: The cautions, and instructions provided in this manual must be read, followed, and always kept available for consultation. CAUTION: Do not modify this equipment without authorization from the manufacturer. Unauthorized modifications to this system are not permitted and void the manufacturer’s warranty. Unauthorized modification might result in a hazard to the user and/or patient. CAUTION: Federal Law restricts this device to sale by or on the order of a medical practitioner. When prescribed for therapeutic purpose, a physician must define the use clearly (for example, total work, maximum heart rate, etc.) to reduce the risk of patient injury. CAUTION: Before beginning any of the setups described in this manual: •

Ensure that all system wiring and cables are routed away from any area where they might be stepped on or rolled over by wheeled equipment.

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For testing and activity patterns in which the positioning chair will be used, the chair should be set to its minimum height before allowing a subject to mount or dismount. It may also help to have a fixed location from which all subjects approach and leave the chair.

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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. Ensure 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 activity. Practice setups and positioning with a healthy subject before attempting to set up an injured patient.

Important Safety Information Read the entire operation manual. Failure to read the manual might result in user error or inaccurate data. Save all documents for reference. CAUTION: • Allow only qualified, trained personnel to install, operate or service this system. • No part of the system can be serviced while in use. • Modification to Biodex equipment must be authorized and approved by Biodex. Replacement parts not provided by Biodex may adversely affect operation and must be approved by Biodex before installation/repair. • If the equipment is modified, it must be thoroughly inspected and tested prior to usage with a patient to ensure safe operation. • Do not use this system a manner other than specified in this guide. If the equipment is used in a non-specified manner, the protection provided by the equipment might be impaired and results could be compromised.

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CAUTION: Never leave patient unattended. This medical electrical equipment requires special precautions for EMC and must be installed and used according to EMC information provided for this document. CAUTION: Only use approved power supplies. CAUTION: Connecting electrical equipment to a multiple socket outlet (MSO) effectively leads to creating an ME SYSTEM, and can result in a reduced level of safety. CAUTION: Operation for: 230 VAC, 50/60 Hz. CAUTION: To avoid risk of electric shock, this equipment must be connected only to supply mains with protective earth. CAUTION: The plug is considered the method of disconnecting the system from main power. Do not place the system in a position where the plug cannot be reached quickly. CAUTION: The system is intended to remain in one location during operation. To relocate the system, the system is disconnected from power source. Use the wheels to move the system. NOTE: Any serious incidents occurring with the use of this device should be reported to the manufacturer and appropriate local regulatory agency by end user, operator, or patient. Examples of local regulatory agency are EU competent authority, country specific Health Agency, or FDA.

Warranty Refer to the warranty card included with the product or contact Biodex Support Services.

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Important Safety Information Considerations for Safe Operation of the System 4: 1. The clinician should always be present during testing or activity sessions. Do not allow subjects to test or exercise by themselves. 2. Range limits should always be set after the subject is positioned according to protocol and before switching to a test or activity mode. Limits should never be set at points that are beyond the safe maximum allowable range of motion for the individual subject. Always assume that previously set limits are inappropriate for successive subjects, or for successive joints on the same subject. Limits should be canceled and reset at the completion of each test or activity session. 3. Range of motion limits should be set ensuring that the mechanical stop on the attachment or fixture will not contact the mechanical stop on the dynamometer. Metal-to-metal contact of these parts during operation will override the system’s normal deceleration function (cushion), causing harsh impacts at ends of ROM. 4. Always educate subject as to function and use of the Comfort Stop buttons. Always place the hand-held remote Comfort Stop (on black coiled cord) in the subject’s free hand before the start of any test or activity session. 5. During set-up, check subject positioning and ability to complete range of motion (slowly) prior to securing stabilization straps. Ensure that both the positioning chair and dynamometer are securely locked in detentes before allowing subject to move through ROM. 6. Before beginning any test or activity session, always inform the subject that the input attachment will now be able to move. 7. Always keep the surrounding area free of equipment and other personnel, especially when the passive mode is to be used. Check for clear, unobstructed path of movement pattern (through complete ROM). 8. Do not operate equipment that has malfunctioned until it has been serviced by a qualified technician or use has been approved by a Service Representative. 9. Use equipment only with recommended power supplies, grounding, and surge suppression. (Refer to site survey or contact Service Department for specifications.) 10. Make sure the Dynamometer tilt and rotation are locked. Tilt and rotation should not be loose during an activity.

CAUTION: Placing hands or fingers between the dynamometer input shaft (or attachment) and the mechanical ROM stops may result in serious injury.

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1. Introduction Intended Use • •

The System 4 is a versatile product used to identify, treat, and document physical impairments and physical therapy progress. It is intended to be used as a testing and training tool to help patients and clinicians identify weaknesses and areas for improvement.

Indications for Use The System 4 is used with patients that may have physical impairments that cause functional limitations. Athletic injuries may include hamstring injury, Anterior Cruciate Ligament (ACL) injury, knee osteoarthritis, lateral ankle sprains, and patellofemoral dysfunction. Other patients include orthopedic, pediatric, and patients with movement disorders, neurologic pathologies, or general deconditioning. System 4 testing can also identify muscle weaknesses to prevent workplace injury (occupational medicine).

Contraindications Absolute Contraindications • • • • • •

Acute strain (musculotendinous unit) or sprain (non-contractile tissue) Soft tissue healing constraints (such as immediately after surgery) Severe pain Extremely limited range of motion (ROM) Severe effusion Joint instability

Relative Contraindications • • • • •

Subacute strain or chronic third-degree sprain Pain Partially limited ROM Joint laxity Effusion

Figure 1.1. The System 4 Positioning Configuration.

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2. Getting Started Controls and Adjustments 1. 2. 3. 4. 5. 6. 7.

Tilt Knob (locking) Tilt Scale Tilt Key Locking Knob Storage Rotation Knob (locking) Position Color Code Label Foot Pedals (travel) 850-000, 840000 (not depicted)

8. Height Lever 9. Comfort Stop Pendant (patientheld) 10. Shaft Red Dot 11. Yoke

12. Rotate Counterclockwise Button 13. Rotate Clockwise Button 14. Hold/Resume Button 15. Comfort Stop

Figure 2.1. Dynamometer Positioning Controls and Adjustments.

Dynamometer Dynamometer Rotation: To rotate the dynamometer in a horizontal plane, loosen the Rotation Knob by turning it counterclockwise. Rotate the dynamometer in either direction. To secure the dynamometer rotation position, tighten the knob in a clockwise direction and ensure that the dynamometer teeth are engaged. Use the Rotation Scale, located on the base of the dynamometer directly beneath the yoke, to note the new position. 11

(Dynamometer Tilt Degrees)

Dynamometer Tilt: Permits rotation of the dynamometer on a vertical plane allowing the shaft axis to tilt upward or downward from the horizontal position. To tilt the dynamometer, support the dynamometer with one hand. With the other hand, loosen the Tilt Knob in a counterclockwise direction. Gently push or pull the dynamometer to the desired position. Tighten the knob firmly in a clockwise direction, and ensure that the dynamometer teeth are engaged, to secure the dynamometer in place. Use the Tilt Scale (located on the yoke) to note the new dynamometer tilt position. Use the Tilt Key (located directly beneath the Tilt Scale for a quick reference during patient set-up.) Dynamometer Height: The dynamometer can be raised or lowered over a range of 14” (35.56cm). Loosen the Height Handle by turning it counterclockwise and simply apply hand pressure to the top or underside of the dynamometer to respectively raise or lower it. Retighten the handle to lock the dynamometer in position. Use the Height Scale, located on the mounting post, to note the new dynamometer height.

NOTE: The weight of the dynamometer is counterbalanced by a pneumatic assembly in the mounting post. When the locking handle is loosened, the dynamometer may tend to gently rise or fall, depending on the weight of attachments affixed to the shaft. After proper height is established, always secure the locking handle. Dynamometer Travel (850-000, 840-000): The Foot Pedals allow the dynamometer to move along the travel in a horizontal plane left or right of the positioning chair. To move the dynamometer, press down on either foot pedal and slide the dynamometer to the desired location. Release the foot pedal to lock the dynamometer in place. To ensure stability, check that the dynamometer is fully locked in a detent (i.e., try to shake the dynamometer). Use the Position Scale on the travel to note position. Rotate Clockwise/Counterclockwise: The Rotate buttons atop the dynamometer allow the shaft to be moved by pressing (and holding) the Rotate button corresponding to the direction the shaft must turn. This function of the Rotate buttons has no effect on the range of motion limits previously established in Setup Mode. Hold/Resume: Stops shaft rotation. Press this button a second time to resume the test or activity session. One Hold/Resume button is located atop the dynamometer next to the Comfort Stop. A second Hold/Resume button is activated by a hand-held remote located to the right of the control panel on the Clinical Data Station (CDS) cart. Comfort Stop: Prior to exercise, educating the user about the Comfort Stops can improve confidence and motivation when using the equipment.

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When the Comfort Stop is used, a pop-up message gives two choices, Abort or Resume:

In the middle of a test, selecting the Abort icon will end the set. Selecting the Resume icon will allow the user to continue where the set left off. During a test where a patient is feeling uncomfortable, the user can select the Abort icon to finish the set rather than resuming it. NOTE: As a safety precaution, the system will not function in any mode if the Remote Comfort Stop is not connected to the dynamometer. CAUTION: Comfort Stops (Dynamometer, Remote): These buttons provide the subject with the ability to instantaneously terminate exercise in any mode. Depressing either the large red button atop the dynamometer or the hand-held remote button causes immediate cessation of dynamometer shaft rotation. The purpose of this control is to guard against moving the subject into a portion of the range of motion that, for any reason, is contraindicated. It should be noted that activating a comfort stop after the onset of discomfort will result in a stoppage of movement while the subject is still in the undesirable portion of the range. Should this occur in Isokinetic or Isotonic mode, with concentric contractions selected, the operator should immediately press the Stop button on the control panel, press Start to free the shaft and allow rotation toward a more comfortable point in the subject’s ROM. (With the shaft free, the operator should manually place the subject in a position such that the limb will not move in the direction of gravity.) CAUTION: Extra consideration is required for resuming dynamometer shaft rotation in the Passive or Reactive Eccentric mode as the patient may be assisted further into a painful portion of the ROM. In this case, remove the patient immediately from the attachment by releasing the hook and loop fastener cuff.

Dynamometer Position Color Code Label: Located on the Dynamometer Yoke Pivot Plate, the

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Dynamometer Position Color Code Label helps the user to quickly position the dynamometer according to the pattern selected. Rotate the dynamometer to the yellow color code positions when setting up to test or exercise the patient’s left side. Rotate the dynamometer to the blue color code positions for right side testing or exercise. Patterns that use the same positioning for both sides utilize the green color code areas.

Positioning Chair

1. Seat Rotation Handle 2. Receiving Tubes 3. Chair Foot Pedals 4. Seat Height Foot Switches 5. Cervical Support Adjustment Knob 6. Seat Back Tilt Handle 7. Seat Back Fore/Aft Handle 8. Stabilization Handles

Figure 2.2. Positioning Chair Adjustments (850-000).

Seat Rotation The positioning chair offers 360 degrees of rotation in the horizontal plane with détente settings at 15-degree intervals. • To rotate the seat in either direction, turn the Seat Rotation Handle toward the rear of the seat. The Seat Rotation Handle is located beneath the seat between the forward receiving tube and forward buckle. • While holding the Seat Rotation Handle, swivel the seat to the desired position. Release the handle to lock the seat in place, making sure the seat sets in the appropriate detente. Note the seat rotation position on the Seat Rotation Scale, located beneath the seat on the seat post. 14

Chair Foot Pedals: The Chair Foot Pedals allow fore/aft adjustment of the positioning chair in relation to the dynamometer. To move the chair along the travel, press down on either foot pedal and slide the chair to the desired location. Release the foot pedal to lock the chair in place. To ensure stability, check that the chair is fully locked in a detente. Use the Chair Position Scale, located on the travel, to note the new position. Seat Back Tilt: This adjustment allows the user to select any of five seat back angle settings: 85, 70, 55, 40 and 25 degrees. To adjust the seat back tilt, pull up on one of the Seat Back Tilt Handles, located on either side of the lower seat back frame. Adjust the seat back to the desired angle. Release the handle and ensure that it locks into the selected detente. Record the new seat back tilt angle from the Seat Back Tilt Indicator, located at the bottom on either side of the seat back frame. CAUTION: Use caution when adjusting the chair position with the patient in the chair. The seat may be raised or lowered with the subject seated. Ensure that all wires are clear and the patient is not strapped to any attachment before beginning to raise or lower it. Seat Height (850-000): The motorized seat may be raised or lowered over a range of 14 inches. To adjust the seat height, step down on the <▲> or <▼> Seat Height Foot Switches, located at the rear base of the chair. Seat Back Fore/Aft: Crank the Seat Back Fore/Aft Handle, located at the back of the seat base,

in a counterclockwise direction to move the seat back forward on the seat. Crank the handle in a clockwise direction to move the seat back toward the rear of the seat. Record the new fore/aft position from the Seat Back Fore/Aft Scale, located along each side of the seat frame near the back belt buckle. Cervical Support: To reposition the Cervical Support, use one hand to hold the support ensuring it will not slip down. With the free hand, turn the Cervical Support Locking Knob in a counterclockwise direction until loose. Lift up or push down on the support until the desired position is achieved. Turn the locking knob in a clockwise direction until tight to secure the support in place. NOTE: Be sure to support the Cervical Support with one hand before loosening the locking knob. If the Cervical Support is not supported, it may slide down and pinch a hand as the knob is loosened. Stabilization Straps: The Positioning Chair is fitted with a Thigh Strap and Buckle (secured toward the front on each side of the seat frame), a Pelvic Strap and buckle (secured directly beneath the Seat Back Tilt handle on the seat back frame,) and a pair of Shoulder Straps and buckles (secured toward the back on each side of the seat base). To secure any strap, lift the buckle handle, insert the strap into the buckle and pull until tight but not uncomfortable for the patient. Press the buckle handle all the way down to secure. 15

Receiving Tubes: There are four receiving tubes located on the seat. Two are positioned at the front of the seat, left and right of center. The remaining two tubes are located one on each side of the seat. These tubes receive the T-Bar, Limb Support Pad and Footrest. Each receiving tube has a locking knob. To loosen the knobs, turn them counterclockwise. To tighten the knobs, turn them clockwise. Stabilization Handles: Located on the side receiving tubes, these handles can be used by the patient for added support, stabilization, and consistent hand positioning during test, exercise, and rehabilitation sessions. These stabilization handles are also convenient for the clinician as a means to pull or push the chair fore or aft on the T-base.

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2 1. 2. 3.

Figure 2.3. Positioning Chair Attachments: T-Bar Adapter Footrest Limb-Support Pad

Seat Back Brace The Seat Back Brace is designed to provide added stability when the seat back is used in a lowered position at zero degrees seat rotation for side lying, supine and prone patterns (particularly of the hip). The Seat Back Brace is adjustable and simple to use. Once installed, setup takes only seconds. 1. Ensure the seat back is in the up position. Rotate the seat to 0 degrees on either side of the seat rotation scale. 2. Line up one rod-end swivel of the Seat Back Brace with the clevis on the seat back and insert the clevis pin. 3. Release the Seat Back Handle and lower the seat back to “10” on the seat back tilt scale. Figure 2.4. Attaching the Seat Back Brace to the System 4 Seat Back Clevis. 16

4. Loosen the Seat Back Brace locking knob. Extend the lower part of the brace and insert the rod-end swivel into the trolley mount clevis. Insert the clevis pin. 5. Position the patient per protocol; lock the Seat Back Brace locking knob to secure. Be sure to loosen the seat locking knob when adjusting the height of the seat or the position of the seat back. Figure 2.5. Attaching the Seatback Brace to the System 4 Trolley Mount Clevis. 6. To rotate the seat to the opposite 0degree position, disconnect the lower end of the back only. Repeat steps four and five.

Figure 2.6. Seat Backbrace Installed and Ready for Use.

The Controller (Located at the bottom, rear, of Computer Data Station) Main Power Switch: Controls main power supply to controller, computer and dynamometer. Contains a circuit breaker to protect against extreme power surges. Breaker is reset by turning the Power Switch OFF (0) and ON (l). NOTE: At the end of each day, leave both the Green Dynamometer and Power switches ON. Then turn OFF the Main Power Switch. This will help prevent possible damage during storms, or electrical surges. Dynamometer Power Switch: This switch controls power to the dynamometer. In the ON position, power to the dynamometer is enabled. In the OFF position, the dynamometer is on Standby. Computer Power Switch: Controls power to the computer and peripherals (including printer and monitor). In the ON position, power to computer, monitor and printer are ON. In the OFF position, power to the computer, monitor and printer are OFF. NOTE: Be sure to properly exit and close the Software application and Windows Programs 17

before turning off the computer. CPU ON/OFF Switch: Use this switch to turn the CPU ON/OFF. Status/Diagnostics Panel (LEDs): This panel provides information to assist in troubleshooting of dynamometer/control panel problems. In the event of a system malfunction, always be sure to record that LEDs light before attempting to correct a problem or restart the system. Contact a Service Representative whenever the status panel indicates a malfunction.

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4 6

1

2 3

Figure 2.8. Rear Panel

Figure 2.9. Front Panel

Figures 2.8 and 2.9. The System 4 Controller front panel (right) and rear of unit (left): 1. Main Power Switch 2. Dynamometer Power Switch 3. Controller Power Switch 4. Status/Diagnostics Panel (LEDs) 5. CPU ON/OFF Switch 6. Remote Access for Analog Signals 7. Auxiliary RS 232 for RTK Interface

Readying the System for Use 1. Turn the main power switch on the back of the controller to the ON (1) position (see Figure 1.8). 2. Ensure that the green dynamometer and computer power switches are set to the ON (I) position. They will be illuminated when ON. 3. Turn on the computer. Whenever the computer is shut down it must be turned on manually. 4. Upon power up, a message will be displayed on the monitor that the system needs to be initialized. Initialization consists of a self-test during that the firmware checks to ensure that the dynamometer and associated hardware are working properly. Initialization must be performed any time the system is turned ON following system shut-down or an interruption in power supply. 5. Remove any attachments from the dynamometer input shaft and select <OK> to proceed with initialization. The dynamometer input shaft will turn fully clockwise and counterclockwise. If any problems are encountered, the system will display an error message. If all circuits and phases of the System 4 dynamometer and hardware are working properly, no error message will be presented and the display advances to the Dynamometer

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Operation screen. The message “Set ROM Limits” should now be displayed in the System Status window at the top of the screen. The system is now ready for use. NOTE: Should a coded initialization error message be displayed, contact Biodex Customer Service at 1-631-924-9000 and Press 3 for Service.

Dynamometer Attachments CAUTION: Shaft Red Dot (dynamometer shaft): The small red dot on the end of the dynamometer shaft provides an index for proper alignment of attachments on the dynamometer setup. When affixing any attachment to the shaft, position the attachment ensuring that its dot for the side to be exercised aligns with the shaft red dot. Failure to properly align the dots may result in a reduced range of motion.

CAUTION: Ensure finger guard is in place when using the knee and hip attachments. Placing hands or fingers between the dynamometer input shaft (or attachment) and the mechanical ROM stops may result in serious injury.

Figure 2.7. Finger Guard Positioned Correctly on Dynamometer for Knee and Hip Attachments.

Figure 2.8. Knee Attachments (Left and Right)

Patterns: Knee:

Extension/Flexion

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Figure 2.9. Hip Attachments (Left and Right)

Patterns: Hip: Extension/Flexion, Abduction/Adduction

Shoulder/Elbow Adapter

Shoulder Attachment

Figure 2.10.

Patterns: Shoulder:

Extension/Flexion, Abduction/Adduction Diagonals

Figure 2.11.

Patterns: Shoulder: Elbow:

Shoulder Attachment (Insert in Shoulder/Elbow Adapter)

Shoulder/Elbow Attachment (Insert in Shoulder/Elbow Adapter)

Internal/External Rotation Extension/Flexion (remove cuff),

NOTE: Only one Shoulder/Elbow Adapter is supplied. The same adapter is used with the Shoulder Attachment and Shoulder/Elbow Attachment.

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