Optiflex CPM Continuous Passive Motion Unit User Manual

OPTIFLEX® TABLE OF CONTENTS Precautionary Instructions... 2 Foreword... 3 Product Description... 3 Package Contents... 3 Installation... 4 Operation Instructions... 4 Quick Start... 5 Pendant Functions... 6 Other Pendant Functions... 10 Pediatric Footplate Setup... 11 User Maintenance... 11 Technical Maintenance... 11 Technical Specifications... 12 Symbol Descriptions... 13 Troubleshooting... 14 Warranty... 15 Parts Drawing... 17 Parts List... 18

PRECAUTIONARY INSTRUCTIONS WARNING – The following precautions should be taken in order to reduce the risk of fire, electrical shock, injury to persons or damage to the OptiFlex®: • Read this manual before assembling or using OptiFlex. • Only use OptiFlex on solid, flat surfaces. • Extreme caution should be taken when in use around children. • Use OptiFlex only as described in this manual. • Keep hair, loose clothing, fingers and all parts of body away from moving parts of OptiFlex. • DO NOT use OptiFlex outdoors or on wet surfaces. • Materials may become flammable or combustible if exposed to a source of ignition. • Disconnect electrical supply before servicing or cleaning. Failure to do so could result in electrical shock or personal injury. • DO NOT use OptiFlex while smoking or around open flame. • Exercise caution when using accessories and auxiliary devices such as muscle stimulators, ColPaCs and other modalities. • Turn power off before unplugging. • Unplug the power supply by grasping the plug not the cord. • Damage may occur to OptiFlex if not transported and stored between 0 and 140°F (-18 to 60°C). • Unplug from power supply when not in use. • DO NOT use if cord or plug is damaged. • Use extra care when touching metal of OptiFlex after exposure to cold or heat. • DO NOT handle any electrical apparatus with wet hands. • DO NOT use OptiFlex as a toy. • Condensation could result and damage OptiFlex if unit is subjected to periods of low temperatures followed by periods of high temperatures.

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• DO NOT use on unstable surfaces or liquid filled devices such as water mattresses or flotation pads. • OptiFlex has been designed for maximum protection against the exposure of urinary incontinence. Precautionary measures should still be taken, though, when any type of liquid comes in contact with an electrical apparatus. • OptiFlex is made from high impact materials. However, structural failure or hidden damage can be caused by shock, impact or dropping the unit. Use care when transporting and storing unit to avoid equipment damage. • To isolate the unit from the power source, disconnect the power cord at the wall outlet. • OptiFlex should only be used after the operator has thoroughly read and understands this manual. • Rapid increases in ROM can cause complications. • OptiFlex is not to be used in the presence of flammable anesthetic mixture with air or with oxygen or nitrous oxide. • Meets IEC/EN 60601-1-2 Electromagnetic Compatibility/interference safety standard. (Care must be taken when operating this equipment around other equipment. Potential electromagnetic or other interference could occur to this or to the other equipment. Try to minimize this interference by not using other equipment in conjunction with it.)

OPTIFLEX USER MANUAL

FOREWORD This manual has been written for the owners and operators of the OptiFlex® continuous passive motion machine. It contains general instructions on operation, precautionary practices, maintenance and parts information. In order to maximize use, efficiency and the life of your OptiFlex, please read this manual thoroughly and become familiar with the controls as well as the accessories before operating the unit. Specifications put forth in this manual were in effect at the time of publication. However, owing to Chattanooga Group's policy of continual improvement, changes to these specifications may be made at any time without obligation on the part of Chattanooga Group, Inc.

PRODUCT DESCRIPTION The OptiFlex is a continuous passive motion machine typically used postoperatively on total knee replacement and Anterior Cruciate Ligament (ACL) repair patients. By repeatedly flexing and extending the affected limb, the OptiFlex lessens the adverse effects of immobilization and trauma on the joint. OptiFlex is a prescription device used under the supervision or by the order of a physician or other licensed healthcare provider.

PACKAGE CONTENTS • OptiFlex • Control Pendant • 1 Package of Soft Goods • 1 Operator's Manual

OPTIFLEX USER MANUAL

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INSTALLATION

WARNING • DO NOT plug in if switch is in ON position. • DO NOT place leg in carriage until power is ON. • If liquid or foreign object comes in contact with OptiFlex, turn power switch OFF and have authorized personnel check the unit. CAUTION • Obese patients can suffer chafing due to contact with carriage frame. • Failure to use securement strap correctly could change anatomical alignment resulting in tissue damage or joint injury. • Unit must be placed on a solid, secure surface. Otherwise, unit could tip causing hip to be dislocated.

OptiFlex® requires minimal installation. No lubrication is necessary and the unit is not required to be sterile. 1. Place OptiFlex unit on a solid, flat surface. 2. Attach the Soft Goods to the carriage of the OptiFlex by using the instructions provided with the Soft Goods. 3. Caution: Use only OptiFlex Soft Goods from the Chattanooga Group, Inc. 4. Plug the three-prong plug into a properly grounded wall outlet.

OPERATION INSTRUCTIONS Setup and operation of the OptiFlex is quick and easy. However, the operation instructions must be followed in order to ensure proper anatomical alignment and use of OptiFlex.

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1. When setting up a new patient, activate RESET to clear the unit (see page 5). Measure the patient from hip joint (greater trochanter) to knee in centimeters. (Photo 1) 2. Adjust OptiFlex femur component to match hip to knee measurement in centimeters. (Photo 2) 3. Carefully place OptiFlex under the affected limb. Align knee joint with the corresponding hinge point on unit. (Photo 3) 4. Adjust the foot plate using the foot plate locking knobs so the patient's foot rests comfortably and the patient kit supports the leg from knee to foot. (Photo 4) 5. Secure the limb in the carriage frame by fastening the strap. (Photo 5)

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OPTIFLEX USER MANUAL

QUICK START FAST BACK ™ Carriage will slow down within 15° of the flexion angle. MODE Used in conjunction with Fast Back, Oscillation Zone and Progressive ROM.

EXTENSION Adjusts the extension angle. FLEXION Adjusts the flexion angle. SPEED Adjusts the speed of operation. EXTENSION / FLEXION DELAY Allows user to program carriage to stop at both the extension and flexion angle for the time programmed. EMERGENCY STOP/START Starts or Stop treatment

OPTIFLEX USER MANUAL

OSCILLATION ZONE ™ Carriage will oscillate three times between the flexion angle and 10° less than the flexion angle. PROGRESSIVE ROM ™ Unit will automatically increase the programmed flexion angle by 1° every hour up to a maximum of 5° per day.

RESET Clear previous treatment settings and completed cycles. UP ARROW Allows user to increase treatment parameters. DOWN ARROW Allows user to decrease treatment parameters. COMFORT ZONE ™ Temporarily decreases the flexion ROM when discomfort is experienced.

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PENDANT FUNCTIONS All user input and feedback is provided through the pendant. The following are descriptions of each button provided with OptiFlex®. Extension: View and modify the extension angle parameter.

How to use: To view the extension angle, press and hold the EXTENSION button. To modify the current extension angle, press and hold the EXTENSION button while pressing either the UP or DOWN ARROW. Flexion: View and modify the flexion angle parameter.

How to use: To view the flexion angle, press and hold the FLEXION button. To modify the current flexion angle, press and hold the FLEXION button while pressing either the UP or DOWN ARROW. Speed: View and modify the speed parameter.

How to use: To view the speed, press and hold the SPEED button. To modify the current speed, press and hold the SPEED button while pressing either the UP or DOWN ARROW. Extension/Flexion Delay: View and modify the delay time for the extension or flexion angles. Using EXTENSION/FLEXION DELAY will cause the carriage to stop at the extension and flexion angle for the time programmed. How to use: To view the extension/flexion delay time, press and hold the EXTENSION/FLEXION DELAY button. You can set independent DELAY times for extension and flexion. If an extension and or flexion delay time is required, simply hold down the DELAY button and the EXTENSION or FLEXION button and use the UP or DOWN ARROWS to adjust the time.

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OPTIFLEX USER MANUAL

Up Arrow: Increases treatment parameters in conjunction with other buttons.

How to use: Select the specific function to increase (SPEED, EXTENSION, FLEXION or EXTENSION/FLEXION DELAY). While pressing and holding the appropriate button, use the UP ARROW to increase the value of the specified function. Down Arrow: Decreases treatment parameters in conjunction with other buttons. How to use: Select the specific function to increase (SPEED, EXTENSION, FLEXION or EXTENSION/FLEXION DELAY). While pressing and holding the appropriate button, use the DOWN ARROW to decrease the value of the specified function. Reset: Resets all parameter and patient counters to factory defaults. How to Use: To reset patient compliance counters, press and hold lightly by inserting a paper clip and accept reset by pressing the MODE button. To display total unit run time and cycles, press and hold RESET for 3 seconds, the total unit time and cycles are temporarily displayed.

CAUTION – Emergency Stop/Start When unit is stopped and STOP/START button is pressed, the unit will immediately begin moving in the opposite direction of the last movement.

COMFORT ZONE

Emergency Stop/Start: Starts or stops the treatment. How to Use: Press the START/STOP button to begin or end the treatment. Comfort Zone™: Temporarily decreases the flexion ROM when discomfort is experienced during treatment. How to Use: Press and the carriage will immediately reverse direction to move toward the extension angle. For the next five cycles, the carriage will operate in a range five degrees less than the angle where the button was pressed. The Comfort Zone Flexion Angle is five degrees less than the angle where the button was pressed. Once five cycles are

OPTIFLEX USER MANUAL

C = Comfort Zone activated temporary flexion limit established. 5° = Five degrees less than the angle where Comfort Zone was activated. Upon completion of five cycles, ROM will increase by one degree each cycle until it reaches P. P = Programmed Flexion angle. S = Start/Finish.

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WARNING If pain is severe, do not use Comfort Zone. Stop treatment immediately. Failure to do so could result in tissue damage and could compromise surgical repair.

complete, the Comfort Zone™ Flexion Angle will be increased by one degree each consecutive cycle until it reaches the currently Programmed Flexion Angle. Note: If COMFORT ZONE is pressed within 30 degrees of the currently Programmed Extension Angle, treatment will stop and the message "Comfort Zone Too Small" will be displayed. Mode: Used together with FAST BACK ™, OSCILLATION ZONE ™ and PROGRESSIVE ROM button to enable and disable the appropriate mode. All three modes or any combination may be used at once. How to Use: Press MODE button along with desired function (FAST BACK, OSCILLATION ZONE and/or PROGRESSIVE ROM).

FAST BACK

Non-Working ROM

Working ROM (10°)

Fast Speed

Slow Speed

Fast Speed

Fast Speed Working ROM Speed = 60°/min.

F = Programmed Flexion Angle E = Programmed Extension Angle

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Fast Back™: When the carriage reaches 15 degrees less than the Programmed Flexion Angle, it will begin to slow down. The deceleration rate will be half of the Programmed Speed when the carriage comes within 10 degrees of the flexion angle. Upon reaching the flexion angle, the carriage will reverse direction and resume the Programmed Speed as it moves towards the extension angle. How to Use: While pressing and holding the MODE button, press the FAST BACK button to enable the FAST BACK mode Note: If both FAST BACK and OSCILLATION ZONE modes are enabled, the carriage will move at the slower of 75°/min and half of the Programmed Speed while in the OSCILLATION ZONE ROM.

OPTIFLEX USER MANUAL

Oscillation Zone™: When the carriage reaches the Programmed Flexion Angle, it will oscillate between the Programmed Flexion Angle and ten degrees less than the flexion angle three times. The ten degree range of motion is known as the OSCILLATION ZONE ROM. While in the OSCILLATION ZONE ROM, the carriage will move at 75 deg/min or the Programmed Speed, whichever is slower. On the third oscillation cycle, the carriage will hold at the flexion angle for the Programmed EXTENSION/FLEXION Delay Time.

How to Use: While pressing and holding the MODE button, press the OSCILLATION ZONE button to enable the OSCILLATION ZONE mode. Note: If both FAST BACK™ and OSCILLATION ZONE modes are enabled, the carriage will move at the slower of 75 deg/min and half of the Programmed Speed while in the OSCILLATION ZONE ROM. Progressive ROM™: When PROGRESSIVE ROM is activated, the unit will automatically increase the Programmed Flexion Angle by one degree every hour, up to a maximum of 5° per day. How to Use: While pressing and holding the MODE button, press the PROGRESSIVE ROM button to enable the PROGRESSIVE ROM mode. Set the desired Final Flexion Angle by pressing and holding the FLEXION Button while using the UP and DOWN Arrows. Accept the Final Flexion Angle by pressing the MODE Button.

OSCILLATION ZONE

Non-Working ROM

Working ROM (10°)

Carriage oscillates 3 times before holding on the last cycle.

H = Optional Hold on Extension /Flexion Limit * = Start / Finish F = Programmed Flexion Angle

KNEE FLEXION ROM VS. TIME

5° Increase per Day

Note: The unit must run for a full hour at the entire ROM before the flexion angle will be increased. The unit will not automatically increase more than five degrees in any 24 hour period. Decreasing the flexion angle will automatically deactivate this mode.

Day 1 Day 2 Day 3 Day 4 Day 5 Day 6 Day 7 I = Initial Knee Flexion ROM F = Final Knee Flexion ROM ROM = I + D(n- 1) x 5 where n is the number of days of therapy

OPTIFLEX USER MANUAL

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OTHER PENDANT FUNCTIONS Independent Delay Time You can set independent DELAY times for extension and flexion. If an extension and or flexion delay time is required, simply hold down the DELAY button and the EXTENSION or FLEXION button and use the UP or DOWN ARROWS to adjust the time. Selectable Scrolling The scrolling feature is disabled at the factory. Should you desire to enable this feature, simply press and hold the DELAY and MODE buttons. The display will scroll patient data for two (2) cycles then return to displaying Current Carriage Angle. Patient Lock-Out The Patient Lock-Out feature prevents the patient from changing any parameter except COMFORT ZONE™ and START/STOP. To enable the Patient Lock-Out feature: Press and hold the UP ARROW and the MODE button for three seconds. A single short beep will confirm that the feature has been activated. Repeating the above sequence will deactivate the feature. A single short beep will confirm that the feature has been deactivated. Language Selection To select display language, press and hold the MODE and EXTENSION buttons simultaneously for 3 seconds. Use and arrows to select desired language and then press MODE to accept.

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OPTIFLEX USER MANUAL

PEDIATRIC FOOTPLATE SETUP 1. Remove footplate by loosening footplate knob. 2. Tighten flexion adjustment knobs. 3. Loosen the tibial adjustment knobs. 4. Remove footplate support. 5. Rotate 180 degrees and replace. 6. Rotate footplate frame 180 degrees. 7. Replace footplate. 8. Tighten all adjusting knobs.

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USER MAINTENANCE To clean OptiFlex®, turn unit off and unplug the power supply. Clean OptiFlex with a damp cloth. DO NOT use abrasive cleaners. A small amount of mild household detergent may be used, if desired. Soft Goods may be laundered as required. However, the same Soft Goods should not be used from patient to patient. Cleaning of Soft Goods will not meet the necessary sanitation guidelines. Replace Soft Goods for each patient.

TECHNICAL MAINTENANCE No attempt should be made to disassemble the unit. Maintenance and all repairs should be made by authorized personnel only. The manufacturer will not be held responsible for the results of maintenance or repairs by unauthorized persons.

OPTIFLEX USER MANUAL

WARNING Disconnect electrical supply from outlet before servicing or cleaning the unit. Failure to do so could result in electrical shock.

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TECHNICAL SPECIFICATIONS Safety OptiFlex® complies with the following standards: UL 2601-1 CAN/CSA 601.1 IEC/EN 60601-1 IEC/EN 60601-1-2 Meets MDD 93/42/EEC, CE 0413 Type “B” Equipment, Class I Suitable for continuous operation

Unit Input: Weight: Length:

120 VAC~50/60 Hz, 40 Watts 28 Lbs. (13 kg) 37 in. (94 cm)

Operation Knee Flexion ROM Limit: Knee Extension Limit: Knee Speed Range : Maximum Patient Weight: Calf Length Range: (knee joint to sole of foot) Thigh Length Range: (hip joint to knee joint) 12

120° 10° Hyper Extension 30°/min. to 150°/min. Nominal 350 Lbs. (159kg.) 10 to 23.5 in. (25.4 to 59.7 cm) 12 to 19 in. (30.5 to 48.3 cm)

OPTIFLEX USER MANUAL

Transportation and Storage Unit should be transported and stored within the following conditions: Temperature:

0 - 140°F (32° - 60°C)

Humidity:

0 - 75% Relative Humidity

SYMBOL DEFINITION Standby Power ON

Standby Power OFF

Emergency Stop

Start

Type B Equipment

Attention, Consult Accompanying Documents

OPTIFLEX USER MANUAL

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TROUBLESHOOTING WARNING Disconnect electrical supply from outlet before servicing or cleaning the unit. Failure to do so could result in electrical shock.

The following is a solutions guide to minor performance problems. Only qualified personnel should service all other equipment problems. PROBLEM

POSSIBLE CAUSE

POSSIBLE SOLUTION

OptiFlex® will not operate.

1. Unplugged at wall outlet.

1. Plug in and push ON/OFF button to ON. 2. Push ON/OFF button to ON. 3. Once power returns, unit will remain stopped until start button is pressed. 4. Plug in pendant to unit. 5. Unplug unit and remove obstruction from path of carriage. 6. Adjust extension angle smaller or flexion angle larger.

2. ON/OFF button not turned ON. 3. Power loss.

4. Pendant unplugged. 5. Carriage travel blocked.

6. Flexion angle set equal to extension angle. Treatment stopped in the middle of operation.

1. Motor overcurrent.

2. Comfort Zone too small.

1. Press START/STOP button. Carriage will move in opposite direction. 2. Comfort Zone button can only be used when ROM is greater than 30 degrees of Programmed Extension Angle.

Note: Pendants of Optiflex® units model 2000 and 2020 will not function on Model 2030 and 2060 OptiFlex units.

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OPTIFLEX USER MANUAL

WARRANTY OptiFlex Chattanooga Group, Inc. ("Company") warrants that the OptiFlex® ("Product") is free of defects in material and workmanship. On the drive train components, including the motor, gearbox, drive screw, drive nut, shaft couple and all drive bearings, this warranty shall remain in effect for two (2) years. All other components shall be warranted for the amount of one (1) year from the date of original consumer purchase of this Product. This warranty extends to any owner of the Product during the warranty period. If this Product fails to function during the warranty period because of defect in material or workmanship, Company or the selling dealer will replace or repair this Product without charge within a period of 30 days from the date on which the defective Product is returned to the Company or the dealer. Company or the dealer will ship the replacement or the repaired Product to the consumer's facility. All repairs must be performed by a service center authorized by Chattanooga Group, Inc. Any modifications or repairs performed by unauthorized centers or groups will void this warranty. To participate in warranty coverage, this Product's warranty registration card (included with Product) must be filled out and returned to Chattanooga Group, Inc. by the original owner within ten (10) business days of purchase. Soft Goods Kit Company warrants the Soft Goods Kit is free of defects in materials and workmanship. This warranty shall remain in effect for thirty (30) days. This Warranty Does Not Cover 1. Replacement parts or labor furnished by anyone other than the Company, the dealer or an approved Company service agent. 2. Defects or damage caused by labor furnished by someone other than Company, the dealer or an approved Company service agent.

OPTIFLEX USER MANUAL

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3. Any malfunction or failure in the Product while it is in the possession of the owner during the warranty period if the malfunction or failure is not caused by a defect in material or workmanship, or if the malfunction or failure is caused by unreasonable use, including the failure to provide reasonable and necessary maintenance. Company Shall Not Be Liable for Incidental or Consequential Damages to Property or Business Some states do not allow the exclusion or limitation of incidental or consequential damages, so the above limitation or exclusion may not apply to you. TO OBTAIN SERVICE from Company or the selling dealer under this warranty, the owner must do or abide by the following: 1. A written claim must be made within the warranty period to the Company or the selling dealer. If the claim is made to the Company, written claim should be sent to: 4717 Adams Road P.O. Box 489 Hixson, TN 37343 USA Phone: 423-870-7200 2. The Product must be returned to the Company or the selling dealer by the owner. This warranty gives you specific legal rights and you may also have other rights which vary from state to state. The Company does not authorize any person or representative to create for it any other obligation or liability in connection with the sale of the Product. Any representation or agreement not contained in the warranty shall be void and of no effect.

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OPTIFLEX USER MANUAL

PARTS DRAWING

OPTIFLEX USER MANUAL

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PARTS LIST

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OPTIFLEX USER MANUAL

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4717 Adams Road P.O. Box 489 Hixson, TN 37343 U.S.A. 1-423-870-2281 1-800-592-7329 U.S.A. 1-800-361-6661 CANADA + 423-870-7200 INTERNATIONAL + 423-870-2046 INTL. FAX www.chattgroup.com

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