Artromot K3 Knee CPM Operations Manual Dec 2007

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Device description

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Device description

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Symbol overview

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Illustrations for device setup

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1. How to use the CPM device 1.1 Fields of application 1.2 Therapy objectives 1.3 Indications 1.4 Contraindications

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2. Description of the ARTROMOT®-K3 2.1 D  escription of the device components 2.2 Description of the programming unit 2.4 Explanation of symbols (connections and nameplate)

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3. Safety statements

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4. Device setup 4.1 C  onnecting the device, performance check 4.2 Mechanical Settings 4.3 Adjusting the Patient Kit

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5. Setting the treatment values 5.1 G  eneral information on programming ARTROMOT®-K3 5.2 P  rogramming ARTROMOT®-K3 5.3 T  herapy parameter details

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6. Care, Maintenance 6.1 Care 6.2 M  aintenance (fuse replacement)

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7. Environmental Protection Statement

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8. Specifications

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9. IEC 60601-1-2:2001 9.2 Electromagnetic immunity 9.2 Electromagnetic immunity 9.3 Recommended Separation Distances

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10. Contact

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11. Technical service 11.1 Technical Hotline 11.2 Shipment 11.3 Spare Parts

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12. Declaration of conformity

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1. How to use the CPM device 1.1 Fields of application

1.3 Indications

ARTROMOT®-K3 is a motor-operated motion device used for Continuous Passive Motion (CPM) for the knee and hip joints.

The CPM device is indicated in the treatment of most injuries and diseases of the knee and hip joints as well as in the postoperative treatment after knee and hip joint surgery. 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 ARTROMOT®-K3 is mainly used to prevent the negative effects of immobilization, to allow patients to regain painless movement of joints at an early stage and to promote healing and achieve a positive functional result.

- operative treatment of fractures, pseudarthrosis and corrective osteotomy - cruciate ligament replacement or reconstruction - endoprosthetic implants

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

1.4 Contraindications

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

Do NOT use ARTROMOT®-K3 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



2. Description of the ARTROMOT®-K3 The motorized CPM device permits extension and flexion of the knee joint in the range of -5 ° - 0 ° - 110 °,

2.1 Description of the device components

and of the hip joint in the range of 0 ° - 8 ° - 86 °.

Note: Please fold out page 2!

It can be used on either side and requires no configuration change.

1. Compartment for storage of programming unit

These are some of the

2. Footplate with patient kit

ARTROMOT®-K3 features:

3. Knobs for ankle adjustment of foot inclination

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

4. Knobs for length adjustment of lower leg

- symbols for easy operation of the programming unit

5. Lower leg patient kit 6. Knee pivot point 7. Knob for femur length adjustment 8. Thigh support

Biocompatibility

9. Thigh patient kit

Those parts of the ARTROMOT®-K3 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.

10. Base 11. Coiled cord 12. Hand-held programming unit 13. Power switch (ON/OFF) 14. Fuse cap 15. Connection for power cord 16. Connection for programming unit 17. Knob for rotation of footplate



2.2 Description of the programming unit

2.2.1 Programming unit in normal mode

set carriage angle

selected therapy protocol

therapy timer

set extension value

set flexion value

selected direction of motion

parameter keys MENU key

“+” key

START key

“-” key

STOP key



2.2.2 Programming unit in MENU selection mode

selected MENU level

set carriage angle

set extension value

set flexion value parameters available for selection, corresponding selection keys

2.2.3 Programming unit in programming mode

selected function

set flexion value

selected parameter (here: flexion)



2.3 Explanation of symbols

Also refer to symbol overview on page 29

extension (stretching the knee) flexion (bending the knee) speed warm-up protocol extension pause flexion pause therapy timer reverse on load feature for patient safety transport setting new patient total therapy time service menu



2.4 Explanation of symbols (connections and nameplate)

alternating current protective earth connection type B applied part power switch OFF power switch ON

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Refer to accompanying documents Do not dispose of product with unsorted household or municipal waste.

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3. Safety statements Definitions

m Warning!

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

Patient hazard- − Only authorized individuals are allowed to operate the ARTROMOT®-K3 device. Individuals are authorized after receiving training in the operation of the device and reading this operation manual.

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

− 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.

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

− 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.

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

− Stop therapy immediately, when you have doubts about the device settings and/or the therapy protocol.

Safety information

− It is important that the patient‘s position is anatomically correct. Check the following settings/positions:

m Danger Explosion hazard-

1. femur length

ARTROMOT®-K3 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.

2. knee joint axis 3. lower leg length and rotational position of the leg 4. patient kits − 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.

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m Warning!

− 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.

Shock hazard - Strictly observe the following warnings. Failure to do so endangers the lives of the patient, the user and other persons involved. − Before use allow the ARTROMOT®-K3 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.

− The patient must be familiar with the functions of the ARTROMOT®-K3 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.

− The ARTROMOT®-K3 device must only be operated in dry rooms. − When disconnecting the device from the power line, remove the plug from the wall outlet first, before disconnecting the cable from the device.

− All accessories used with the ARTROMOT®-K3 device must first be approved by ORMED. − 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.

− 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 ORMED, if you have questions in this matter. − Do not use multiple portable socket outlets (MPSO) to connect the device to the power line. ARTROMOT®-K3 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. − Before cleaning and service interventions, disconnect the device from the power line by removing the power cord from the wall outlet. − Liquids must not be allowed to enter the CPM device or the programming unit. If liquids have entered into the devices, ARTROMOT®-K3 must be immediately checked by a service technician, before it can be reused.

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m Warning!

m Caution!

Equipment malfunction -

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.

− 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.

m Caution! Equipment damage - − Check that the voltage and frequency ratings of your local power line are those indicated on the nameplate.

− Refer repair and maintenance to authorized persons.

− The leg support element withstands a maximum continuous load of 30 kg (66.13 lb).

− Route all cables below the device frame to either side, ensuring that they cannot get caught in the moving parts during operation.

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

− Inspect ARTROMOT®-K3 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.

− Do not expose the ARTROMOT®-K3 device to direct sunlight, because some of the components may reach inadmissibly high temperatures.

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4. Device setup Note: For a better understanding of each step, please fold out pages 3 and 32.

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.

4.1 Connecting the device, performance check

m Caution! Equipment damage- Connect only the original programming unit designed for the device in use. Any attempt to connect another programming unit to this device may cause damage.

1. Connect the power cord to socket (15) of the device and connect the mains plug to a wall outlet with a nonfused earthed wire (100 to 240 Volt, 50/60 Hz). 2. Connect the programming unit (12) to socket (16) of the device. 3. Turn the power switch (13) on.

4.2 Mechanical Settings

4. Follow these steps to set the carriage to the home position: • Press the MENU button on the programming unit until you reach programming level 3.

1. Set the carriage to the home position (see 4.1) or to an angle that allows the patient to position the leg on the support without experiencing any pain.

• Press the New Patient parameter key .

2. Adapting the carriage to the femur length (Fig. 2)

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

• Loosen the two fixation screws (7). • Adjust the appropriate femur length (8). • Tighten the screws (7) to fix the setting.

Performance check If the programming unit can be operated as described above and ARTROMOT®-K3 enters the home position (for home position values, refer to section 5.3), the device has passed the performance check.

m Caution! Equipment damage- Please do not try to pull out the femur length adjustment past the stop.

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

3. Adapting the carriage to the tibia length (Fig. 3)

− An audio signal sounds.

• Loosen the two fixation screws (4).

− The device switches off immediately.

• Adjust the appropriate tibia length. The setting should exactly match the length of the patient‘s lower leg.

− The message „ERR“ and an error code (e.g. ERR 5) appear on the display.

• Tighten the screws (4) to fix the setting.

In this situation, you may attempt to restart the device by turning it briefly 14

4. Adjusting the dorsal extension / plantar flexion position (Fig. 4) • Loosen the two fixation screws (3). • Set the foot plate (2) to an angle that is comfortable for the patient. • Tighten the screws (3) to fix the angle setting. 5. Adjusting the foot rotation position (Fig. 5) • Loosen the fixation screw (17). • Set the foot plate (2) to a rotation position that is comfortable for the patient. • Tighten the screw (17) to fix the setting.

4.3 Adjusting the Patient Kit 1. Using the Velcro tapes, attach the patient kits for lower leg (5) and thigh (9) to the frame of the motion element. (Fig. 6 an Fig. 7) 2. Now position the patient‘s leg on the carriage and adjust the height with the help of the Velcro tapes and by repeating the steps at 1. Ensure that the exercise will only be performed in a range of motion that does not cause any pain and provides maximum comfort for the patient,

m Caution! Patient hazard - Ensure that the rotational axes of the CPM device and of the knee joint coincide both in the vertical and in the horizontal plane (Fig. 8).

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5. Setting the treatment values m Warning!

• The symbol above the parameter key appears in reverse video.

Patient hazard -

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. 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.

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. Note: See also 2.2 and 2.3 as well as page 29!

5.1 G  eneral information on programming ARTROMOT®-K3

5. Then press the START key to start therapy. If a special function is activated, the carriage will first move to the middle position. Press the START key again to start therapy.

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

• Refer to section 5.3 for a description of the parameters.

Note!

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

• To view the set parameter values, press the corresponding parameter key. However, this is only possible when you press the STOP key first. • To prevent accidental changes of the parameter settings, lock the keys by simultaneously pressing the + (plus) and – (minus) keys.

If you wish to return to the previous programming level (e.g. from level 3 to 2), press the MENU key and hold it pressed for a short time.

Press both keys again to unlock.

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

• Emergency stop function: ARTROMOT®-K3 will stop immediately, when any of the keys is pressed during therapy. Patient treatment can be resumed by pressing the START key. The device will automatically change the direction.

• The corresponding symbol appears on the display in a larger format. • The set value is displayed. 16

LEVEL 3:

• If the carriage is positioned within the programmed range of motion at the time therapy begins, the therapy session will start immediately.

- Transport setting - New patient - Total therapy time - Service menu

• If the carriage is positioned outside the programmed range of motion at the time therapy begins, it will first move to the angle setting „extension +10°“. It will stop in this position and you can start the therapy session by pressing the START key.

Note! It is possibe to modify individual treatment parameters or all parameters together. If individual treatment parameters are modified, the settings of all other parameters remain unchanged.

5.2 P  rogramming ARTROMOT®-K3

5.3 Therapy parameter details

To program the different settings of the ARTROMOT®-K3, access the respective programming level.

• You access the different programming levels by repeated depressions of the MENU key.

You change between levels by pressing the MENU key repeatedly. The display always indicates the currently selected level.

• You select the treatment parameters with the corresponding parameter key.

The following treatment values, settings and information can be entered/ viewed on the programming unit (12):

• You change the treatment values with the + / - keys and you enable/disable functions by pressing the corresponding parameter key again.

LEVEL 1:

• You save the settings by pressing the STOP key.

- Extension (stretching the knee) - Speed

LEVEL 1:

- Warm-up protocol

n Extension (stretching)

- Fexion (bending the knee)

- Maximum knee extension: -5 degrees

- Maximum hip extension: 8 degrees

LEVEL 2:

n Flexion (bending)

- Extension pause - Therapy timer

- Maximum knee flexion: 110 degrees

- Reverse on load feature for patient safety

- Maximum hip flexion: 86 degrees

- Flexion pause

Note!

The programmed value and the value measured at the patient‘s knee may deviate slightly. 17

In this case, a circle replaces the clock symbol. The circle fills as the therapy time progresses.

n Speed The speed can be adjusted between 1 % and 100 % in steps of 1 %. Default: 100 %

n Reverse on load feature for patient safety The device automatically starts moving in the opposite direction of the last movement when the patient‘s resistance (load) exceeds the set value. Adjustable levels for reverse on load feature: 1-25

n Warm-up protocol During warm up, the patient will slowly become used to the set maximum extension and flexion values, starting from the center position. The warm up protocol starts in the middle between the two maximum values set for stretching and bending. With each cycle, the range of motion is increased, within 15 cycles the maximum value is attained. Default: disabled

minimum setting 1 = 25 kp maximum setting 25 = 45 kp At 1/25 kp very little resistance will cause the device to reverse; at 25/45 kp, a high resistance is required to initiate the reversal. Default: 45 kp

LEVEL 2:

Note!

n Extension pause

• These values are approximate values.

Pauses occur at the extension limit, just before the bending movement starts. Pauses are adjustable in steps of 1 second between 0 and 30 seconds. Default: no pause

• The force needed is measured at the frame around the foot.

m Caution! n Flexion pause

Patient hazard -

Pauses occur at the flexion limit, just before the stretching movement starts. Pauses are adjustable in steps of 1 second between 0 and 30 seconds. Default: no pause

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.

n Therapy timer

LEVEL 3:

Default setting is continuous operation.

n Transport setting 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.

A clock symbol in the upper righthand corner of the display identifies the continuous mode of operation. The clock indicates the elapsed therapy time. In the continuous mode, the device must be stopped with the STOP key. However, the therapy timer can be set in steps of 1 minute to any value between 1 and 300 minutes. When the time has elapsed, the device switches automatically off and stops in the position - set extension value +10°. 18

n New patient With this function, the CPM device will move to the home position, allowing the mechanical settings to be completed. Select the function and press the START key. The device enters the home position and existing therapy parameters will be deleted. The „new patient“ function (home position) selects the following settings: - extension: 25 ° - flexion: 35 ° - speed:

100 %

- warm up:

disabled

- extension pause:

0

- flexion pause:

0

- timer:

continuous operation

- reverse on load: 45 kp - total therapy time: 0 n Total therapy time The total therapy time is the added sum of operating hours. If the device is used by only one patient, this time is equivalent to the duration of all the patient‘s therapy sessions. Deleting the stored therapy time Press and hold the parameter key for 5 seconds or select the New Patient function. n Service menu For service purposes only, refer to Service Manual. Reminder You save the selected parameter values by pressing the STOP key.

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6. Care, Maintenance 6.1 Care

6.2 Maintenance (fuse replacement)

m Warning! Shock hazard - Check before each use

Remove the power cord from the wall outlet before cleaning.

Visually inspect the device for signs of mechanical damage before each use.

Shock hazard, equipment damage ⎯ Liquids must not enter the device or the programming unit.

If you detect damage or malfunctions that may impair the safety of the patient or of the operator, have the device repaired before using it.

• ARTROMOT®-K3 can be disinfected by wiping down with a disinfectant. Thus, it complies with the special hygiene standards for medical technical equipment.

Technical inspections For safety, the devices require regular maintenance. To maintain the functional and operational safety, check all components for damage and loose connections at least once a year.

• The enclosure can be cleaned with common disinfectants and mild household cleaning agents.

These checks should be performed by persons with adequate training and experience. Damaged and worn parts must immediately be replaced with original spare parts by authorized staff.

• Only use a damp cloth to wipe the CPM device down.

m Caution!

The device does not require additional regular maintenance.

Equipment damage - − The plastic material used is not resistant to mineral acids, formic acid, phenols, cresols, oxidants and strong organic or inorganic acids with a pH value below 4. − Use only clear disinfectants to prevent discoloration of the device. − Do not expose the CPM device to strong ultraviolet radiation (sunlight) and fire. − Do not use cleaning agents that contain chloride.

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