OptiFlex Ankle Continuous Passive Motion Therapy Unit User Manual

Contents Description of the OptiFlex™-Ankle System

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OptiFlex™-Ankle setup illustrations

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1.

How to use the CPM device

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1.1 1.2 1.3 1.4

5 5 5 5

2.

Fields of application Therapy objectives Indications Contraindications

Description of the OptiFlex™-Ankle

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2.1 2.2 2.3 2.4

6 7 10 11

Description of the device components Description of the programming unit Explanation of symbols Explanation of symbols (connections and nameplate)

3.

Safety information

4.

Device setup

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4.1 4.2

15 16

5.

6.

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Connecting the device, performance check Adjusting the device to the patient

Setting the treatment values

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5.1 5.2 5.3

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General information on programming OptiFlex™-Ankle Programming OptiFlex™-Ankle Standard Treatment value details

Care, Maintenance, Transport, Conversion

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6.1 6.2 6.3 6.4

Care Maintenance (fuse replacement) Transport Conversion

23 23 24 25

7.

Environmental Protection Statement

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8.

Specifications

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9.

IEC 60601-1-2:2001

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9.1 9.2 9.3

27 28 30

Electromagnetic emissions Electromagnetic immunity Recommended Separation Distances

10. Contact

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11. Technical service

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11.1 Technical Hotline 11.2 Shipment 11.3 Spare Parts

31 31 31

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1.1 Fields of application

1.3 Indications

OptiFlex™-Ankle is a motor-operated Continuous Passive Motion (CPM) device providing motion to the ankle joint.

The CPM device is indicated in the treatment of most injuries and diseases of the ankle joint as well as in the postoperative treatment after joint surgery and in the treatment of joint diseases. Examples:

Suitable for use in hospitals, clinics, general practices and rental services, it is an important supplement to medical and therapeutic treatment.

- joint distortion and contusion - arthrotomy and arthroscopy procedures in combination with synovectomy, arthrolysis or other intra-articular interventions

1.2 Therapy objectives

- mobilization of joints in anesthetized patients

CPM therapy with OptiFlex™-Ankle is mainly used to prevent the negative effects of immobilization, to allow patients to regain painless mobility of joints at an early stage and to promote healing and achieve a positive functional result.

- exercise-stable fractures after surgery, pseudoarthrosis and osteotomy - myoplasty - arthroplasties including implantation of endoprostheses

Other objectives of therapy include: - improvement of joint metabolism - prevention of joint stiffness

1.4 Contraindications

- promotion of the regeneration and healing of cartilage and damaged ligaments

Do NOT use OptiFlex™-Ankle on patients with:

- faster hematoma/fluid resorption - improved lymph and blood circulation

- acute inflammatory processes in the joints, unless on the order of a physician

- thrombosis and embolism prophylaxis

- spastic paralysis - unstable osteosynthesis

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1. How to use the CPM device

2. Description of the OptiFlex™-Ankle The motorized CPM device provides the following passive motion to the ankle joint:

2.1 Description of the device components

plantar flexion / dorsal extension 50° / 0° / 40°

Note: Please see also page 2!

inversion / eversion 40° / 0° / 20°

1. Clamping levers to adjust the height of the calf support assembly

It can be reconfigured for use on either side and allows patients to exercise in bed and while sitting on a chair.

2. Calf support assembly 3. Motor A (center of rotation for dorsal extension/plantar flexion) 4. Bracket for programming unit

Note

5. Clamping lever to adjust the inclination of the carriage

To unambiguously represent the current position of the CPM device, the values for plantar flexion and inversion are marked with the symbol "-" both on the display and in this document.

6. Aiming pin for adjustment of the rotational axis of the upper ankle joint 7. Footplate 8. Knurled screw for adjustment of the footplate height 9. Knurled screw to adjust the footplate to the leg length

These are some of the OptiFlex™-Ankle features:

10. Motor B

- anatomically correct setup

11. Footplate bracket

- physiological movements

12. Thumbscrew to secure motor B on the moving bracket for dorsal extension / plantar flexion

- programming unit for precise adjustment of patient-specific therapy values

13. Bore hole to mount motor B to the moving bracket for dorsal extension/ plantar flexion

- symbols for easy operation of the programming unit - chip card for storage of the programmed therapy parameters

14. CPM base

Biocompatibility

16. Power switch (ON/OFF)

15. Moving bracket for dorsal extension/ plantar flexion 17. Fuse cap

Those parts of the OptiFlex™-Ankle device that come into contact with the patient when the device is used as intended, are designed to fulfil the biocompatibility requirements of the applicable standards.

18. Connection for power cord 19. Locking device to adjust the height of the carriage 20. Perforation to set the height of the carriage 21. Patient chip card 22. Programming unit 23. Nameplate 24. Connection for programming unit 6

2.2 Description of the programming unit

2.2.1 Programming unit in normal mode set angle of motor A

set angle of motor B

current position of motor A (arrow pointing up = dorsal extension arrow pointing down = plantar flexion)

current position of motor B (left or right - solid foot symbol / arrow pointing inward = inversion arrow pointing outward = eversion)

selected therapy protocol

therapy timer set eversion value

set dorsal extension value

set inversion value set plantar flexion value motor B - selected direction of motion

motor A - selected direction of motion

parameter keys MENU key

“+” key

START key

“-” key

STOPkey

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Patient chip card

2.2.2 Programming unit in MENU selection mode

set carriage angle for dorsal extension / plantar flexion

set carriage angle for inversion / eversion

current position of motor A (arrow pointing up = dorsal extension arrow pointing down = plantar flexion)

current position of motor B (left or right - solid foot symbol / arrow pointing inward = inversion arrow pointing outward = eversion)

parameters available for selection and corresponding parameter keys

selected MENU level

2.2.3 Programming unit set to ROM programming

current maximum dorsal extension value selected function

set carriage angle

selected parameter (here: dorsal extension)

current maximum plantar flexion value

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selected function

status of the selected function (here: speed)

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2.2.4 Programming unit in general programming mode

2.3 Explanation of symbols

dorsal extension plantar flexion inversion eversion pause timer speed new patient load reversal motor A load reversal motor B motor A ON/OFF motor B ON/OFF transport setting synchronized/nonsynchronized mode total therapy time service menu

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2.4 Explanation of symbols (connections and nameplate)

English

alternating current

protective earth connection

type B applied part

power switch OFF

power switch ON

Refer to accompanying documents

Do not dispose of product with unsorted household or municipal waste.

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3. Safety information

Definitions

Safety information

It is mandatory to read the safety statements before use of the CPM device. The safety statements are classified as follows:

Explosion hazard –

Danger OptiFlex™-Ankle is not designed for use in areas where an explosion hazard may occur. An explosion hazard may result from the use of flammable anesthetics, skin cleansing agents and disinfectants.

Danger This term indicates an imminent hazard. If not avoided, this hazard will result in death or serious injury.

Warning This term indicates a hazard. If not avoided, this hazard can result in death or serious injury.

Caution This term indicates a potential hazard. If not avoided, this hazard can result in minor personal injury and/or product/property damage.

Warning Patient hazard – - Only authorized individuals are allowed to operate the OptiFlex™-Ankle device. Individuals are authorized after receiving training in the operation of the device and reading this operation manual. - Before using the device, the operator must ascertain that it is in correct working order and operating condition. In particular, the cables and connectors must be checked for signs of damage. Damaged parts must be replaced immediately, before use. - Before therapy, a test run consisting of several exercise cycles must be completed, first without and then with the patient. Check that all setting screws are tightened. - Stop therapy immediately, when you have doubts about the device settings and/or the therapy protocol. 12

- It is important that the patient's position is anatomically correct. Therefore, carefully verify the following settings/positions:

Warning Shock hazard –

- Before use allow the OptiFlex™-Ankle to reach room temperature. If the device has been transported at temperatures below 0 °C (32°F), leave it to dry at room temperature for about 2 hours, until any condensation has disappeared.

- Movements must not cause any pain or irritation. - Patients must be fully conscious while being instructed in the use of the CPM device and during therapy.

- The OptiFlex™-Ankle device must only be operated in dry rooms.

- The choice of the therapy parameters to program and of the therapy protocols to use is restricted to the responsible physician or therapist. It is the physician's or therapist's decision whether or not to use the CPM device on a specific patient.

- When disconnecting the device from the power line, remove the plug from the wall outlet first, before disconnecting the cable from the device. - When connecting the device to other equipment or when creating a medical system, check that the sum of leakage currents will not cause any hazard. Please contact Chattanooga Group, if you have questions in this matter.

- The patient must be familiar with the functions of the OptiFlex™-Ankle programming unit and the unit must be within easy reach of the patient, allowing him or her to stop therapy, if needed. Patients unable to operate the programming unit, e.g. paralytic patients, must never be left unattended during therapy.

- Do not use multiple portable socket outlets (MPSO) to connect the device to the power line. OptiFlex™Ankle must be connected to a properly installed wall outlet with a non-fused earthed wire. Before connecting the power cord, it must be completely unrolled and placed such that it will not get caught in the moving parts of the device.

- After data storage, write the patient's name on the patient chip card. The card should only be used for this patient. If the patient chip card is used for another patient, be sure to delete the previous patient's data from the card first (see: section 5.3, “New patient”). Use original chip cards only .

- Before cleaning and service interventions, disconnect the device from the power line by removing the power cord from the wall outlet.

- All accessories used with the OptiFlex™-Ankle device must first be approved by Chattanooga Group.

- Liquids must not be allowed to enter the CPM device or the programming unit. If liquids have entered into the devices, OptiFlex™-Ankle must be immediately checked by a service technician, before it can be reused.

- Do not allow parts of the body or any objects (such as blankets, cushions or cables) to get caught in the moving parts of the CPM device.

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Strictly observe the following warnings. Failure to do so endangers the lives of the patient, the user and other persons involved.

1. carriage angle 2. ankle joint axis/carriage axis motor A 3. Footplate adjustment 4. Calf support assembly

Warning

Caution

Equipment malfunction –

Equipment damage –

- Magnetic and electrical fields are capable of interfering with the proper performance of the device. For this reason make sure that all external devices operated in the vicinity of the CPM device comply with the relevant EMC requirements. X-ray equipment, MRI devices, radio systems and cell phones are possible sources of interference as they may emit higher levels of electromagnetic radiation. Keep the CPM device away from these devices and verify its performance before use.

- Check that the voltage and frequency ratings of your local power line are those indicated on the nameplate. - The leg support element withstands a maximum continuous load of 20 kg (44.1lb). - Do not allow any objects (such as blankets, cushions, or cables) to get caught in the moving parts of the CPM device. - Do not expose the OptiFlex™Ankle device to direct sunlight, because some of the components may reach inadmissibly high temperatures.

- Refer repair and maintenance to authorized persons. - Route all cables below the device frame to either side, ensuring that they cannot get caught in the moving parts during operation. - Inspect OptiFlex™-Ankle for damage and loose connections at least once a year. Damaged and worn parts must immediately be replaced with original spare parts by authorized staff.

Caution Preventing chafing and pressure sores – If your patient is adipose, very tall or very short, be sure to prevent chafing and pressure sores. Place the leg concerned in a moderate abductive position, if deemed appropriate.

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4. Device setup 6. Follow these steps to set the carriage to the home position

Note: For a better understanding of each step, please see also pages 2 and 3.

- Initial adjustment for new patients

4.1 Connecting the device, performance check

Press the MENU key on the programming unit three times to access programming level 3 (with each key press, you advance one level). Press the “new patient” parameter key and select this function (a check mark appears in the circle next to the function).

1. Connect the power cord to socket (18) of the device and connect the mains plug to a wall outlet with a non-fused earthed wire (100 to 240 Volt, 50/60 Hz).

Press the START key. The CPM device automatically enters the home position.

2. Turn the power switch (16) on.

- Adjustment with programmed chip card

Caution

Insert the original patient chip card (21) into the programming unit (22).

Equipment damage Be sure to lift the moving bracket for dorsal extension / plantar flexion (15) a little, relieving the strain on it, before you either press the locking pins for the height adjustment together or loosen the clamping lever for adjustment of the inclination (5).

Press the START key. The CPM device automatically enters the home position. Performance check If the programming unit can be operated as described above and OptiFlex™-Ankle enters the home position (for home position values, refer to sections 5.3), the device has passed the performance check.

3. Release the locking device (19). To do so, first relieve the strain on the carriage by lifting the moving bracket for dorsal extension / plantar flexion (15) a little. Then press the two black pins of the locking device together simultaneously (Fig. A).

The device also runs performance checks regularly during operation. This is what happens, if a problem is identified:

4. Set the carriage to an angle of approx. 60°, then release the pins of the locking device. Check that the pins engage in the perforation (20).

− An audio signal sounds. − The device switches off immediately.

5. Again, hold the moving bracket for dorsal extension / plantar flexion (15) and release the clamping lever for adjustment of the inclination (5). Then lower the moving bracket for dorsal extension / plantar flexion (15) until it forms an angle of 45° with the base. Close the clamping lever to lock the carriage in that position (Fig. B).

− The message "ERR", accompanied by a code number (e.g. ERR 5), appears on the display. In this situation, you may attempt to restart the device by turning it briefly off and on again with the power switch. If the error message persists, have the device inspected by a Service technician, before using it again. 15

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Insert the original patient chip card (21) into the programming unit (22).

that the patient is comfortably positioned. If necessary, repeat steps 2 to 5 to achieve a perfect setup.

4.2 Adjusting the device to the patient

Note Before any treatment is possible, adjust the device as follows:

- The aiming pin (6) is a valuable aid in adapting the carriage's rotational axis to the compromise center of rotation of the upper ankle joint. It identifies the correct compromise axis (Fig. F).

1. Before you adjust the OptiFlex -Ankle to the patient, you may have to convert the device for use on the left or right foot (see section 6.4 Conversion). TM

2. First lift the moving bracket for dorsal extension / plantar flexion (15) a little to hold it securely and to remove the strain. Simultaneously press the two black pins of the locking device (19) together. Now you can adjust the carriage to the correct height. Release the pins of the locking device (19). Check that the pins engage in the perforation (20) (Fig. A).

- If the CPM device is to be used on a supine patient, it is recommended to select a hip angle of approx. 40° at the OptiFlex™-Ankle.

3. Continue to hold the moving bracket for dorsal extension / plantar flexion (15) and release the clamping lever for adjustment of the inclination (5). Adjust the correct inclination for the carriage. Close the clamping lever to lock the carriage in that position (Fig. B).

- Cover the leg support assemblies with disposable tissues, when using the OptiFlex™-Ankle immediately after surgery. This helps prevent discoloration.

Caution Equipment damage –

- Before you change the carriage's inclination and/or height, always lift the moving bracket for dorsal extension / plantar flexion a little.

4. Place the patient's leg on the carriage and adjust the footplate (7) to the length of the patient's leg. To do so, loosen the knurled screw (9) and adjust the footplate accordingly. It is the purpose of this setting to adjust the rotational axis of the CPM device to the compromise center of rotation of the upper ankle joint. Check that the foot is firmly positioned against the footplate. Tighten the knurled screw (9) (Fig. C).

Caution Patient hazard – - Ensure that the rotational axes of the carriage and of the ankle joint coincide both in the vertical and in the horizontal plane (Fig. F). - Before you change the carriage's inclination and/or height, always lift the moving bracket for dorsal extension / plantar flexion a little.

5. Loosen the clamping lever adjusting the height of the calf support assembly (1) (Fig. D) and the knurled screw adjusting the height of the footplate (8) (Fig. E). Set the calf support assembly and the footplate to a level where the rotational axis of the carriage and the compromise center of rotation of the upper ankle joint coincide. Close the clamping lever (1) and tighten the knurled screw (8) (Fig. D). 6. Check the settings and make sure 16

5. Setting the treatment values This is what happens when you press one of the parameter keys to select a parameter:

Warning Patient hazard –

- The set value is displayed. - The symbol above the parameter key appears in reverse video.

4. With the + / - keys (plus/minus) you change the displayed value. When you press and hold the key, the value will change at a higher rate.

Note! See also 2.2 and 2.3

Some of the (special) functions can only be enabled and disabled. This is done by pressing the corresponding parameter key or with the + / - keys. Active parameters are identified with a check mark in the circle next to the symbol.

5.1 General information on programming OptiFlex™-Ankle

5. Having programmed all parameters, press the STOP key to save the values.

1. You activate the programming mode by briefly pressing the MENU key on the programming unit.

6. Then press the START key: OptiFlex™-Ankle will check the set values, it moves to the middle position and stops.

2. The treatment parameters and functions are allocated to four programming levels (four per level).

7. Press the START key again to start therapy.

To be able to program a parameter you will have to access the corresponding programming level. This is also done with the MENU key. With each key press you advance one level. The code M1, M2, etc. that appears in the middle of the display indicates the programming level.

In the synchronized mode, the carriage will then move from the middle position to the maximum eversion value. Afterwards, the carriage will simultaneously move to the maximum inversion value and to the maximum plantar flexion value, and then simultaneously to the maximum dorsal extension value and the value halfway between inversion and eversion. After reaching this position, the cycle restarts: maximum eversion at the same time as halfway between dorsal extension / plantar flexion, etc.

3. You activate the treatment parameters and functions with the four parameter keys below the display. The symbols above the four parameter keys indicate the assigned parameters and functions.

After activation of the START key in the non-synchronized mode the motors will perform random movements, each motor reversing after reaching the maximum values. 17

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- The corresponding symbol appears on the display in a larger format.

Before therapy, a test run consisting of several exercise cycles must be completed without the patient. Then repeat the test run with the patient and check that the movement does not cause any pain.

- Position the patient on the CPM device and press the START key to initiate therapy.

Note! - Refer to sections 5.3 for a description of the parameters. - To view the set parameter values, press the corresponding parameter key. Before, however, you have to press the STOP key and access the correct menu level.

5.2 Programming OptiFlex™-Ankle Standard

- To prevent accidental changes of the parameter settings, lock the keys by simultaneously pressing the + (plus) and – (minus) keys.

To program the different settings of the OptiFlex™-Ankle, access the respective programming level. You change between levels by pressing the MENU key. The display always indicates the currently selected level.

- Press both keys again to unlock.

The following treatment values, settings and information can be entered/viewed on the programming unit (22):

- Selecting the "New Patient" function will automatically delete the data on the patient chip card. When you have finished programming the unit and press the STOP key, the settings will automatically also be saved to the patient chip card.

LEVEL 1: - dorsal extension - plantar flexion - inversion

- Emergency stop function: OptiFlex™-Ankle will stop immediately, when any of the keys is pressed during therapy. When the START key is pressed in the synchronized mode, the carriage will move to the position halfway between the set values, and stops. Patient treatment can be resumed by pressing the START key. When the START key is pressed again in the non-synchronized mode, the carriage will reverse its direction.

- eversion

MENU LEVEL 2: - pause - therapy timer - speed - new patient

MENU Patients with a programmed chip card

LEVEL 3: - reverse on load - motor A

- First complete the mechanical adjustments.

- reverse on load - motor B

- Then insert the chip card (the patient is not yet positioned on the CPM device).

- motor A ON/OFF - motor B ON/OFF

- Press the START key: the device will move to the middle position of the parameters stored on the chip card and stops.

MENU continued on next page 18

LEVEL 4:

LEVEL 1

- transport setting - synchronized/ non-synchronized mode

■ dorsal extension maximum value: 40 degrees

- total therapy time

maximumvalue: - 50 degrees

Note

■ inversion

- While you adjust the extension/flexion values, the carriage will move to the set range. This allows you to easily and quickly determine the ROM where the patient does not experience any pain.

■ eversion

- The ankle entered last for the respective directions of motion will be saved in each case.

Note

5.3 Treatment value details

- To ensure a physiological motion, the carriage moves to the following positions in the synchronized mode in the following sequence:

- To access the programming level you need, press the MENU key repeatedly.

maximum dorsal value at the same time as halfway between inversion/eversion

maximum value: - 40 degrees

maximum value: 20 degrees

- The programmed values and the values measured at the patient's foot may deviate slightly.

- The treatment parameters are selected with the different parameter keys. - To change the treatment values, press the + / – keys.

maximum eversion value at the same time as halfway between dorsal extension / plantar flexion

- To enable/disable a function, press the respective parameter key again.

maximum plantar flexion at the same time as maximum inversion

- To save the entered values, press the STOP key.

- To ensure that the movements you program are physiological in nature, we recommend to program the carriage in the following order: 1. Programming the maximum dorsal extension value 2. Resting the foot by programming a plantar flexion of 0° 3. Programming the maximum eversion value continued on next page 19

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■ plantar flexion

- service menu

4. Resting the foot by programming an inversion of 0°

the continuous mode of operation. The clock indicates the elapsed therapy time.

5. Programming the maximum plantar flexion value

In the continuous mode, the device must be stopped with the STOP key.

6. Programming the maximum inversion value

However, you can also select therapy durations of 1 to 59 minutes in steps of 1 minute and of 1 to 24 hours in steps of 30 minutes.

- When the START key is pressed in the synchronized mode, the device will first move from the middle position to the maximum eversion value. Afterwards, the carriage will simultaneously move to the maximum inversion value and to the maximum plantar flexion value, and then simultaneously to the maximum dorsal extension value and to the value halfway between inversion and eversion. After reaching this position, the cycle restarts: maximum eversion at the same time as halfway between dorsal extension / plantar flexion, etc.

When the time has elapsed, the device switches automatically off and stops in the middle between the set limit values. In this case, a circle replaces the clock symbol. The circle fills as the therapy time progresses.

■ speed The speed can be adjusted between 5 % and 100 % in steps of 5 %. default setting: 50 %

■ new patient

LEVEL 2

With this function, the CPM device will move to the home position. Select the function and press the START key. The device enters the home position and existing therapy parameters will be deleted.

■ pauses Pauses occur at each programmed maximum value. These are the three pause points:

On OptiFlex™-Ankle devices with a patient chip card the factory defaults are restored. All values stored on the chip card will be deleted.

maximum dorsal value at the same time as halfway between inversion / eversion maximum eversion value at the same time as halfway between dorsal extension / plantar flexion

The carriage stops in the home position, dorsal extension / plantar flexion = 0° and inversion / eversion = 5°.

maximum plantar flexion at the same time as maximum inversion

The "new patient" function (home position) selects the following settings:

Pauses can be set to any value between 0 and 59 seconds in steps of 1 second, and to values between 1 and 59 minutes in steps of 1 minute. default setting: no pause

■ therapy timer Default setting is continuous operation. A clock symbol in the upper righthand corner of the display identifies

- dorsal extension:

20°

- plantar flexion:

- 20°

- inversion:

-5°

- eversion:

15°

- pauses:

0

- timer:

continuous operation continued on next page

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50 %

- reverse on load motor A:

25

- reverse on load motor B:

25

- motor A:

ON

- motor B:

ON

- synchronized mode:

enabled

- total therapy time:

0

- special functions:

disabled

Caution Patient hazard – The reverse on load feature is a safety measure to protect the patient in the event of cramps, spasms, locked joints and similar situations. The manufacturer cannot be held liable for misuse of this feature.

■ motor A ON/OFF To allow an isolated movement, the motors can individually be turned on and off. Motor A performs dorsal extension and plantar flexion movement, motor B performs eversion and inversion.

LEVEL 3 ■ reverse on load - motor A (safety circuit)

For an isolated eversion / inversion movement, set motor A to the appropriate position (dorsal extension / plantar flexion), then turn the motor off.

In the synchronized mode, the carriage automatically moves to the middle position when the patient's resistance (load) exceeds the set value.

In the normal operating mode, the display will show the symbol for the dorsal / plantar movement disabled . default setting: motor A ON

In the non-synchronized mode, the carriage automatically moves in the opposite direction when the patient's resistance (load) exceeds the set value.

■ motor B ON/OFF

Adjustable levels for reverse on load feature: 1 - 25 at level 1, very little resistance will cause the device to reverse; at level 25, a high resistance is required to initiate the reversal. default setting: level 25

To allow an isolated movement, the motors can individually be turned on and off. Motor A performs dorsal extension and plantar flexion movement, motor B performs eversion and inversion.

■ reverse on load - motor B (safety circuit)

For an isolated dorsal extension / plantar flexion movement, set motor B to the appropriate position (inversion / eversion), then turn the motor off.

In the synchronized mode, the carriage automatically moves to the middle position when the patient's resistance (load) exceeds the set value.

In the normal operating mode, the display will show the symbol for the inversion / eversion movement disabled . default setting: motor B ON

In the non-synchronized mode, the carriage automatically moves in the opposite direction when the patient's resistance (load) exceeds the set value.

Note

Adjustable levels for reverse on load feature: 1 - 25 at level 1, very little resistance will cause the device to reverse; at level 25, a high resistance is required to initiate the reversal. default setting: level 25

Please note that one motor (A or B) must always be turned on. Otherwise the display will show the message:

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- speed:

Caution

LEVEL 4

Patient hazard –

■ transport setting

The synchronized operation is recommended as a general rule. However, medical and/or therapeutic indications may call for the non-synchronized mode. In the non-synchronized mode, particular caution and attention on the part of the physician/therapist is required to rule out any risk for the patient.

With this function, the carriage will move to a position optimally suited for packing the CPM device. Select the function and press the START key. The carriage moves to the transport position. In the top left-hand corner of the display you will see (also refer to chapter 6 Transport). ■ synchronized/non-synchronized mode

■ total therapy time

Motors A and B can run in synchronized or non-synchronized mode.

Under menu item "total therapy time" of OptiFlex™-Ankle you can view each patient's total therapy time (duration of all the patient's therapy sessions).

synchronized: Motors A and B perform a synchronized movement according to the ankle joint's physiological motion pattern:

Deleting the stored therapy time Press and hold the parameter key for 5 seconds or select the New Patient function.

From the middle position the carriage first goes to the maximum eversion value. Afterwards, the carriage will simultaneously move to the maximum inversion value and to the maximum plantar flexion value, and then simultaneously to the maximum dorsal extension value and to the value halfway between inversion and eversion. After reaching this position, the cycle restarts: maximum eversion at the same time as halfway between dorsal extension / plantar flexion, etc.

■ Service MENU For service purposes only, refer to Service Manual.

Reminder: You save the set parameter values by pressing the STOP key.

During operation the synchronized mode is indicated in the top left-hand corner by the symbol . non-synchronized: Both motors run independently of each other within the selected ranges of motion. To enable the non-synchronized mode, disable the synchronized mode. During operation the non-synchronized mode is indicated in the top left-hand corner by the symbol . default setting: synchronized mode enabled

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