RFLEX KNEE CPM USERS MANUAL

TABLE OF CONTENTS

Sammons Preston CPM Unit

Foreword………………………………...1 CPM Unit Therapy...2-5 Precautionary Instructions...2-4 Product Description...5 Indications & Contraindications...5 Specifications...6-10 R-FLEX CPM Unit...6-10 Nomenclature...11 R-FLEX CPM Unit…………...11 Unpacking...12 Set Up Instructions...13-15 R-FLEX CPM Unit Set Up...13-14 Set Up for Pediatrics or Short Leg…...15 Hand Controller Operation...16-18 Cleaning and Maintenance...19 Warranty…………...20

FOREWORD

Sammons Preston CPM Unit

Thank you for purchasing the Sammons Preston R-FLEX Continuous Passive Motion (CPM) unit. This manual contains general safety, operating, maintenance and care instructions for the owners and operators of the CPM units. At the time of publication the information contained herein was current and up to date. However, due to continual technological improvements and increased clinical knowledge in the field of CPM treatment, as well as Sammons Preston’s policy of continual improvement, Sammons Preston reserves the right to make periodic changes and improvements to our equipment and documentation without any obligation on the part of Sammons Preston. Read, understand and follow the information contained in this manual. Stay current with the latest clinical developments in the field of CPM treatment and observe all applicable precautionary measures for treatment. Keep informed on appropriate indications and contraindications for the use of CPM therapy.

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CPM UNIT THERAPY

Sammons Preston CPM Unit

Precautionary Instructions

The precautionary instructions found in this section and throughout this manual are indicated by specific symbols. Understand these symbols and their definitions before operating this equipment. The definition of these symbols are as follows: =CAUTION- Text with a “CAUTION” indicator will explain possible safety infractions that could have the potential to cause minor to moderate injury or damage to equipment. =WARNING- Text with a “WARNING” indicator will explain possible safety infractions that could potentially cause serious injury and equipment damage. =DANGER- Text with a “DANGER” indicator will explain possible Safety infractions that are imminently hazardous situations that could result in death or serious injury. =EXPLOSION HAZARD- Text with an “Explosion Hazard” indicator will explain possible safety infractions if this equipment is used in the presence of flammable anesthetics. IMPORTANT SAFEGUARDS When using electrical products, especially when children are present, basic safety precautions should always be followed, including the following: DANGER: TO REDUCE THE RISK OF ELECTROCUTION: Always unplug this product immediately after using. Do not use while bathing. Do not place or store product where it can fall or be pulled into a tub or sink. Do not place in or drop into water or other liquid. Do not reach for a product that has fallen into water. Unplug immediately. WARNING: TO REDUCE THE RISK OF BURNS, ELECTROCUTION, FIRE, OR INJURY: Use indoors only. A product should never be left unattended when plugged in. Close supervision is necessary when this product is used by, on, or near children or invalids. Use this product only for its intended use as described in this manual. Do not use attachments not recommended by the manufacturer. Never operate this product if it has a damaged cord or plug. If it is not working properly, has been dropped or damaged, or dropped into water, return it to a service center for examination and repair. Keep the cord away from heated surfaces. Never use while sleeping or drowsy. Never drop or insert any object into any opening. Do not use outdoors or operate where aerosol (spray) products are being used or where oxygen is being administered. Connect this product to a properly grounded outlet only. See grounding instructions.

2

CPM UNIT THERAPY

Sammons Preston CPM Unit

CAUTION: This equipment may cause electromagnetic or other interference between other devices. If this occurs, move the device away from the affected equipment. Work in a range of motion as instructed by your healthcare practitioner. If you experience increased pain, swelling, or any adverse reactions while using this product, immediately consult your health care practitioner. Set up and use of this equipment should be in a low traffic location and away from children and pets. WARNING: Make sure the hand control is accessible to the operator before starting this equipment. The STOP/ START button on the hand control is the only way of stopping the motion for disabled patients or children using the unit. The physician defines the protocol and ensures that it is correctly implemented. CAUTION: It is important to install and use this equipment in accordance with the instructions, to prevent harmful interference to other devices in the vicinity. If this equipment does cause harmful interference to other devices, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures: • Reorient or relocate the other device(s). • Increase the separation between the equipment. • Connect this equipment into an outlet on a circuit different from that to which the other device(s) are connected. • Consult the manufacturer or field service technician for help. EXPLOSION HAZARD R-FLEX CPM NOT SUITABLE FOR USE IN THE PRESENCE OF A FLAMMABLE ANAESTHETIC MIXTURE WITH AIR, OXYGEN OR NITROUS OXIDE

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CPM UNIT THERAPY

Sammons Preston CPM Unit

WARNING: R-FLEX CPM needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in this manual. Portable and mobile RF communications equipment can affect R-FLEX CPM. The use of accessories, transducers, and cables other than those specified by the manufacturer, may result in increased emissions or decreased immunity of the CPM. The CPM should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the CPM should be observed to verify normal operation in the configuration in which it will be used.

WARNING Use of accessories, transducers and cables other than those specified, such as transducers and cables sold by the manufacturer as replacement parts for internal components, may result in increased emissions or decreased immunity of the equipment or system.

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CPM UNIT THERAPY

Sammons Preston CPM Unit

Product Description The purpose of the R-FLEX CPM unit is to provide continuous passive motion to the knee joint to increase circulation, range of motion and to prevent scarring in the joint. The R-FLEX is an anatomically aligned CPM

which mirrors the path of the knee as it goes through its range of motion from full-or hyper-extension (-10o) to full flexion (120o) with speeds of 55 to 140 degrees per minute.

Indications, Clinical Benefits & Contraindications Indications • Knee replacement surgery • Fractures (patellar, tibia plateau, femoral, etc.) • Arthrolysis • Hip surgery, including hip replacement, hip pinning, osteotomy, etc. • Ligament repairs • Arthroscopic surgery (meniscetomies, patellectomies, etc.) • Burns, joints sepsis. Clinical Benefits • Breaks the cycle of trauma, inflammation and the loss of range of motion • Prevents joint stiffness • Speeds the recovery of post-operative range of motion • Maintains the quality of the joint surface • Reduces pains and edema • Promotes joint cartilage healing • Reduces hospitalization time • Reduces the need for pain medication • Provides immediate post-operative continuous passive motion • Digital ROM readout on the patient hand control for positive reinforcement • Maintains desired positions for stretching and muscular rest Contraindications USE OF CPM THERAPY IN GENERAL SHOULD BE AVOIDED OR DISCONTINUED, AT LEAST TEMPORARILY, IF SIGNS OF HYPERTHERMIA, IRRITATION, SWELLING, BLEEDING, OR INCREASED OR PERSISTENT PAIN ARE OBSERVED. ACUTE INFLAMMATORY CONDITIONS, SUCH AS ACUTE ARTHRITIS, OR DESTRUCTIVE BONE OR JOINT DISEASES, SHOULD NOT BE TREATED WITH CPM. PRODUCT IS LATEX FREE. PATIENTS WHO HAVE BONE CANCER, WARPED JOINT SURFACES, SPASTIC PARALYSES, UNSTABLE FRACTURES AND UNCONTROLLED INFECTION SHOULD NOT BE TREATED WITH CPM. R-FLEX CPM UNIT IS NOT ADAPTED FOR PATIENTS WHO ARE TALLER THAN 6’7”(2m) OR SHORTER THAN 4’7”(1.40m).

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CPM UNIT SPECIFICATIONS

Sammons Preston CPM Unit

Table 1. Physical and Electrical Specifications Size Setup for Use: Length Width Height

Weight:

Without accessories With accessories Fully packaged

Electrical Specifications: Input Fuse

29.6” 14.2” 30.4” 27.5 lbs 28.5 lbs 32.0 lbs 110 VAC 60Hz 30W 2.5 A - 250V~

Enviromental Requirements: Temperature: Operating Transport & Storage Humidity: Operating Transport & Storage Atmospheric Pressure:

14°F to 104°F (-10°C to 40°C) -22°F to 140°F (-30°C to 60°C) Up to 80% Up to 90%, non-condensing 700 hPa to 1060 hPa

Electromagnetic Compatibility: In accordance with IECB 1.1.2 Water Enclosure Protection:

IPXO

Safe Work Load: Classification:

No more than 45 lbs Class I, Type B

Grounding Instructions: This product should be grounded. In the event of an electrical short circuit, grounding reduces the risk of electric shock by providing an escape wire for the electric current. This product is equipped with a cord having a grounding wire with a grounding plug. The plug must be plugged into an outlet that is properly installed and grounded. DANGER Improper use of the grounding plug can result in a risk of electric shock. Check with a qualified electrician or serviceman if the grounding instructions are not completely understood, or if in doubt as to whether the product is properly grounded. This product is factory equipped with a specific power supply to permit connection to a proper electric circuit. Make sure that the product is connected to an outlet having the same configuration as the plug. No adaptor should be used with this product. Do not modify the plug provided-if it will not fit the outlet, have the proper outlet installed by a qualified electrician.

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CPM UNIT SPECIFICATIONS Table 2 Cable List Cable

Sammons Preston CPM Unit

Max Length (inch)

Potentiometer Communication Cable Hand Controller Communication Cable Power Cord USB Cable

80 92 158 87

Table 3 Guidance and manufacturer’s declaration - electromagnetic emissions The R-FLEX CPM is intended for use in the electromagnetic enviroment specified below. The customer or the user of the R-Flex CPM should assure that it is used in such an environment.

Emission test

Compliance

RF emissions CISPR 11

Group 1

RF emissions CISPR 11

Class A

Harmonic emissions IEC 61000-3-2

Class A

Voltage fluctuations/ flicker emissions

Complies

Electromagnetic enviroment - guidance The R-FLEX CPM uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. The R-FLEX CPM is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. The R-FLEX CPM is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. The R-FLEX CPM is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

IEC 61000-3-3 The R-FLEX CPM is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Table 4 Guidance and manufacturer’s declaration - electromagnetic immunity The R-FLEX CPM is intended for use in the electromagnetic enviroment specified below. The customer or the user of the R-Flex CPM should assure that it is used in such an environment.

Immunity test Electrostatic discharge (ESD) IEC 61000-4-2 Electrical fast transient/burst IEC 61000-4-4 Surge IEC 61000-4-5

IEC 60601 test level ±6 kv contact

±6 kv contact

±8 kv air

±8 kv air

±2 kv for power supply lines

±2 kv for power supply lines

Electromagnetic environment guidance Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30% Mains power quality should be that of a typical commercial or hospital enviorment

±1 kv for input/output lines ±1 kv differential mode

±1 kv for input/output lines ±1 kv differential mode

Mains power quality should be that of a typical commercial or hospital enviorment

±2 kv common mode

±2 kv common mode

Compliance level

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CPM UNIT SPECIFICATIONS

Sammons Preston CPM Unit

Table 4 continue Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11

<5% UT (>95% dip in UT) for 0.5 cycles

<5% UT (>95% dip in UT) for 0.5 cycles

40% UT (60% dip in UT) for 5 cycles

40% UT (60% dip in UT) for 5 cycles

70% UT (30% dip in UT) for 25 cycles

70% UT (30% dip in UT) for 25 cycles

<5% UT (>95% dip in UT) for 5 sec

<5% UT (>95% dip in UT) for 5 sec

Mains power quality should be that of a typical commercial or hospital environment. If the user of the R-FLEX CPM requires continued operation during power mains interruptions, it is recommended that the R-FLEX CPM be powered from an uninterruptible power supply or a battery

Power frequency Power frequency magnetic fields should be at levels char(50/60 Hz) 3 A/m 3 A/m acteristic of a typical location in a typical commercial or magnetic field hospital environment IEC 61000-4-8 NOTE UT is the a.c. mains voltage prior to application of the test level.

Table 5 Guidance and manufacturer’s declaration - electromagnetic immunity The R-FLEX CPM is intended for use in the electromagnetic enviroment specified below. The customer or the user of the R-Flex CPM should assure that it is used in such an environment.

Immunity test

Conducted RF IEC 61000-4-6

Radiated RF IEC 61000-4-3

IEC 60601 test level

3 Vrms 150 kHz to 80 MHz

3 V/m 80 MHz to 2.5 GHz

Compliance level

Electromagnetic enviroment -guidance Portable and mobile RF communications equipment should be used no closer to any part of the R-FLEX CPM, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended Separation Distance  3,5  d =  P  V1 

3V

 3,5  d =  P  E1 

80 MHz to 800 MHz

7 d =   P 800 MHz to 2.5 GHz  E1  where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacture and d is the recommended separation distance in metres (m)

3V/m

Field strengths from fixed RF transmitters as determined by an electromagnetic site survey a, should be less than the compliance level in each frequency range b. Interference may occur in the vicinity of equipment marked with the following symbol.

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CPM UNIT SPECIFICATIONS

Sammons Preston CPM Unit

Table 5 continue NOTE 1 At 80 MHz and 800 MHz, 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. a

Field strengths from fixed transmitters, such as base station for radio (cellular/cordless) telephone and land mobile radios, amateur radio, AM and FM radio bradcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic enviroment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the R-FLEX CPM is used exceeds the applicable RF compliance level above, the R-FLEX CPM should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the R-FLEX CPM.

b

Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m

Table 6 Recommended separation distances between portable and mobile RF communications equipment and the R-FLEX CPM The R-FLEX CPM is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the R-FLEX CPM can help prevent electromegnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the R-FLEX CPM as recommended below, according to the maximum output power of the communications equipment.

Rated maximum output power of transmitter W

Separation distance according to frequency of transmitter m 150 kHz to 80 MHz 80 MHz to 800MHz 800 MHz to 2.5GHz  3,5  d =  P  V1 

 3,5  d =  P  E1 

7 d =  P  E1 

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 metres (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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CPM UNIT SPECIFICATIONS

Sammons Preston CPM Unit

Table 7 R-FLEX CPM Accessories List Accessory/Cable Power Cord Potentiometer Cable Hand Controller Cable Steward snap-on ferrite

Manufacturer Xuan Hua Electric Manufacturing Co. Ya Sheng Cable Factory Ya Sheng Cable Factory Steward, A Unit of Laird Technologies

Model 10A250V SP20260 SP20350 28A2026-0A2

WARNING Use of the accessory or cable with R-FLEX CPM unit other than those specified may result in increased emissions or decreased immunity of the R-FLEX CPM.

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NOMENCLATURE

Sammons Preston CPM Unit

R-FLEX CPM Unit Components 1. Calf Support 2. Thigh Support 3. Foot Cradle 4. Hand Controller 5. Thigh Length Adjustment Knobs 6. Calf Length Adjustment Knobs 7. Foot Cradle Adjustment Knobs 8. Transport Handle 9. Bedmount Adjustment Device 10. Bedmount Adjustment Knobs 11. ON/OFF Switch and Fuses 12. Potentiometer Housing

1

2

8

11

4

12

3 5

10

6

7

9

R-FLEX CPM LED Display 1. LED Screen 2. Indicator Light 3. INCREASE/DECREASE Function Key 4. EXTENSION Setting Key 5. FLEXION Setting Key 6. TIMER Function Key 7. PAUSE Function Key 8. SPEED Function Key 9. FORCE Function Key 10. STOP/START Function Key 11. USB Communication Port

1 2 3

4 5

6

7

9 10

8

11

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UNPACKING

Sammons Preston CPM Unit

Package Contents: 1 R-FLEX CPM Assembly 1 Foot Cradle Assembly 1 Bedmount Adjustment Device 1 Users Manual 1 Service Manual

Optional Accessories: 1 R-FLEX Managment Software and Drive Installation CD 1 USB Cable

Unpacking instructions: 1. Remove R-FLEX CPM assembly from the box 2. Slide the foot cradle out and place it in the upper right position 3. Ensure that all required components and parts are present. Refer to the previous page. 4. Check the CPM unit and container for damage. Report any substantial damage to the shipper. 5. Save packaging and preserve the integrity of the packaging in case the unit is ever returned for servicing. 6. Connect the hand controller to the CPM unit.

IMPORTANT:

Check that the electrical socket is in good condition and is suitable for the power supply cord. The plug may be connected to any standard socket with a grounded pin. Use the original cable supplied with the machine ONLY when connecting to the power supply. Ensure that the cable remain free around the device to prevent damage.

Power Cord Connection

Hand Controller Connection

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SET UP INSTRUCTIONS

Sammons Preston CPM Unit

R-FLEX CPM Unit Set Up 1. Unpack and place the CPM unit where it is to be used 2. Attach the soft goods (pads) on the CPM unit. (Pads need to be purchased separately) Foot Pad slips over the Foot Plate, attach the straps onto the Calf and Thigh Supports.

Foot Pad

Straps Attach the Calf and Thigh Pad onto the straps.

Calf and Thigh Pad

3. Plug the power cord into a 110/120V AC wall outlet close to the machine. Locate the power switch to ‘OFF’ position. 4. Automatically calibrate the R-FLEX CPM a. Adjust the Thigh Support to the maximum reading on the Femur Scale which is 18”. b. Turn on the power and hold down EXT key and FLX key simultaneously. The code SEL and CAL will blink in the ‘Extension’ and ‘Flexion’ display windows on the hand controller. c. Stop pressing the EXT and FLX keys. The unit is now automatically calibrated. d. The R-Flex CPM unit should be observed traveling to full extension. The reading on the hand controller in the ‘Range of Motion’ display window should read ZERO when the calibration procedure is completed. e. After the unit is calibrated, the hand controller can be set and operated as normal.

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SET UP INSTRUCTIONS

Sammons Preston CPM Unit

5. Measure the patient’s involved leg in centimeters or inches from the hip joint to the midline of the knee joint, set the femur scale to this mesurement using thigh length adjustment knobs. Adjust the thigh support to the corresponding value on the scale. Femur Scale Thigh Ajustment

Calf Ajustment

6. Position the CPM unit so that the hip pivot is 1.5” to 2” from the patient’s rear end. The knee axis should align with the axis of the knee pivot. 7. Adjust the calf support by moving the foot cradle so that it meets the sole of the foot. To adjust the calf support, loosen the adjustment knobs and slide the foot cradle to the proper length. Secure by tightening the two adjustment knobs. 8. R-FLEX CPM Unit has a unique feature with its bedmount adjustment device. It is used to prevent migration of the unit during operation. To adjust the device, loosen the two bedmount knobs and extend the device until it is firm against a solid barrier, such as a foot board. Secure the two knobs to lock the position.

Note: Do not use this as a carry handle or lifting point.

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SET UP FOR PEDIATRICS OR SHORT LEGS

Sammons Preston CPM Unit

1. Loosen Calf Adjustment Knobs and remove the Foot Cradle. DO NOT REMOVE THIGH ADJUSTMENT KNOBS. 2. Loosen both Foot Cradle Adjustment Knobs and rotate both Foot Tubes 180 degrees so that the Foot Cradle is in the location shown in the photo below.

Relocate the Foot Cradle

3. Slide the Foot Cradle back into the CPM unit. Secure by tightening the Calf Adjustment Knobs, adjust the Foot Cradle angle, and tighten the Foot Cradle Adjustment Knobs.

Pediatric Setup

15

HAND-CONTROLLER OPERATION

Sammons Preston CPM Unit

Before Starting the Machine Follow the hand-controller operation instructions to set flexion, extension, speed, pause duration, and force. Run the CPM unit for a full range cycle to ensure the patient’s involved leg is aligned correctly. The machine should now be fitted to begin the rehabilitation. If the knee joint does not mirror the movement of the machine joint, adjust the calf or thigh adjustment knobs to keep the knee in the proper alignment. R-FLEX CPM Unit Technical Parameter Parameter Treatment Mode Extension Limit Flexion Limit Extension Pause Duration Flexion Pause Duration Timer Speed Force

Value Range Normal -10 ~ 120 Degrees -10 ~ 120 Degrees 0 ~ 999 Seconds 0 ~ 999 Seconds 0 ~ 999 Minutes 1 ~ 9 ( 55o ~ 140o /min ) 1~9

Hand-Controller Operation Instruction 1. Turn on the power switch located at the base of the machine. 2. Default parameters are preset after the CPM unit is turned on. 3. Press STOP/START key to initiate the CPM unit. 4. To change the parameter setting, follow the instructions below. Indicator Light START/STOP the unit Press START/STOP key once to start the unit and press it again to stop the unit. Green indicator light shows ‘on’ status, and comes off when the unit is stopped.

Display/Change Extension Range Press EXT key to display extension value, the value will blink in the ‘Extension’ display window. Press / to reset the extension limit, the new value will blink and be locked in 5 seconds. Full range is from -10o to 120o. 16

HAND-CONTROLLER OPERATION

Sammons Preston CPM Unit

Display/Change Flexion Range Press FLX key to display flexion value, the value will blink in the ‘Flexion’ display window. Press / to reset the extension limit, the new value will blink and be locked in 5 seconds. Full range is from -10o to 120o.

Display/Change Speed Value Press SPEED key to display speed value, the value will blink in the ‘Range of Motion’ display window. Press / to reset the speed, the new value will blink and be locked in 5 seconds. Or press the SPEED key again to validate the setting.

Display/Change Force Range Press FORCE key to display force value, the value will blink in the ‘Range of Motion’ display window. Press / to reset the force, the new value will blink and be locked in 5 seconds. Or press FORCE key again to validate setting.

Display/Change Pause of Extension Limit Press PAUSE and EXT key to display the pause of extension limit, the value will blink in the ‘Extension’ display window. Press / to reset the pause of extension limit, the new value will blink and be locked in 5 seconds. 17

HAND-CONTROLLER OPERATION

Sammons Preston CPM Unit

Display/Change Pause of Flexion Limit Press PAUSE and FLX key to display the pause of flexion limit, the value will blink in the ‘Flexion’ display window. Press / to reset the pause of flexion limit, the new value will blink and be locked in 5 seconds.

Display/Change Timer Press TIMER key to display timer, the value will blink in the ‘Range of Motion’ display window. Press / to change the timer setting, the new value will blink and be locked in 5 seconds.

Display Count Down of Timer Press TIMER key twice to display count down of timer. Press TIMER key one time to display the time set, press TIMER key a second time and the time remaining will be displayed in ‘Range of Motion’ display window.

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