ARTROMOT-S3 Operating Instructions July 2007

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Contents Device description

3

Figures

252

Symbol Overview

249

1.

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

45 45 45 45 45

2.

ARTROMOT®-S3 description 2.1 Description of the device components 2.2 Description of the programming unit 2.3 Explanation of symbols 2.4 Explanation of symbols (connections and nameplate)

46 46 47 50 51

3.

Safety information

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4.

Device setup 4.1 Connecting the device, performance check 4.2 Adjusting the device to the patient

55 55 56

5.

Setting the treatment values 5.1 General information on programming ARTROMOT®-S3 5.2 Programming ARTROMOT®-S3 Standard 5.3 Treatment value details – Standard model 5.4 Programming ARTROMOT®-S3 Comfort 5.5 Protocol details – Comfort model 5.6 Examples of use/sample protocols

58 58 60 60 65 66 70

6.

Care, Maintenance, Transport, Conversion 6.1 Care 6.2 Maintenance (fuse replacement) 6.3 Transport 6.4 Conversion

73 73 73 74 76

7.

Environmental Protection Statement

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8.

Specifications

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9.

IEC 60601-1-2:2001 9.1 Electromagnetic emissions 9.2 Electromagnetic immunity 9.3 Recommended separation distances

78 78 79 81

10. Contact

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11. Technical Service 11.1 Technical hotline 11.2 Shipment 11.3 Spare parts

82 82 82 82

12. Declaration of conformity

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1. How to use the CPM device

1.3 Indications

ARTROMOT®-S3 is a motor-operated Continuous Passive Motion (CPM) device providing motion to the shoulder joint.

The CPM device is indicated in the treatment of most injuries and postoperative conditions and diseases of the shoulder joint.

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

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

1.2 Therapy objectives

- all types of arthoplasty - mobilization of joints in anesthetized patients

CPM therapy with ARTROMOT -S3 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. ®

- operative treatment of fractures, pseudoarthrosis, if exercise-stable - decompression surgery (acromioplasty) - endoprosthetic implants - soft tissue surgery in the armpit and the shoulder girdle

Other objectives of therapy include: - improvement of joint metabolism

- tumor surgery in the shoulder region

- prevention of joint stiffness (arthrofibrosis)

1.4 Contraindications

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

Do NOT use ARTROMOT®-S3 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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English

1.1 Fields of application

2. ARTROMOT®-S3 description The motorized CPM device supports the following movements of the shoulder joint: Adduction/abduction

0° - 30° - 175°

Internal/external rotation

90° - 0° - 90°

1. Programming unit 2. Patient chip card 3. Compartment for storage of programming unit 4. Armrest for healthy arm 5. Wheels 6. Connection for power cord 7. Power switch (ON/OFF) 8. Instrument fuse 9. Connection for motion element 10. Thumbscrew for adjustment of the backrest angle 11. Folds down the backrest (transport position) 12. Adjustment for horizontal adduction/abduction 13. Holding tube for height adjusment 14. Locking screw for height adjustment 15. Insertion tube for height adjustment 16. Motor A 17. Holding tube for length adjustment (upper arm) 18. Clamping lever for length adjustment (upper arm) 19. Insertion tube for length adjustment (upper arm) 20. Locking screw for elbow range 21. Motor B 22. Elbow support 23. Forearm support 24. Strap for forearm restraint 25. Holding tube for length adjustment (forearm) 26. Clamping lever for length adjustment (forearm) 27. Insertion tube for length adjustment (forearm) 28. Locking screw for swivel mechanism 29. Handle 30. Headrest adjustment1 31. Height adjustment for shoulder restraint1 32. Height adjustment for shoulder restraint1 33. Ball joint for headrest1 34. Locking pin

Elevation (flexion) 0° - 30° - 175° with elbow bent between 60° and 90° Horizontal adduction/ abduction (manual adjustment only)

0° -120°

It can be reconfigured for use on either side.

Note ! To allow the current position of the CPM device to be clearly indicated, the internal rotation values on the display and throughout this document are identified with "-". These are some of the outstanding ARTROMOT®-S3 features: - anatomically correct setup - physiological movements - maximum possible ranges of motion - programming unit for precise adjustment of patient-specific therapy values - chip card for storage of the programmed therapy parameters - easy transport Biocompatibility Those parts of the ARTROMOT®-S3 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.

2.1 Description of the device components

Subject to technical modifications (06/2007)

Note: Please fold out page 3!

1

46

Only with ARTROMOT®-S3 comfort

2.2 Description of the programming unit

patient chip card set angle of motor A

set angle of motor B

selected therapy protocol

therapy timer

set abduction value

set external rotation value

set adduction value

set internal rotation value

motor A - selected direction of motion

motor B - selected direction of motion parameter keys MENU key

+ (plus) key

START key

- (minus) key

STOP key

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2.2.1 Programming unit in normal mode

2.2.2 Programming unit in MENU selection mode set carriage angle for internal / external rotation

set carriage angle for abduction/adduction

selected MENU level selectable parameters and the corresponding selection keys

2.2.3 Programming unit set to ROM programming

selected function

current maximum value selected for abduction or external rotation (here: abduction)

selected parameter (here: abduction)

set carriage angle for abduction/adduction or internal/external rotation

current maximum value selected for adduction or internal rotation (here: adduction)

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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

Also refer to symbol overview on page 249. Standard protocols:

Comfort protocols:

Abduction

Warm-up protocol

Adduction

Isolation program

Internal rotation

Therapy documentation Abduction/adduction

External rotation Therapy documentation Internal/external rotation Pause Oscillation Timer Stretching in abduction Speed Stretching in internal rotation

New patient Reverse on load - motor A

Stretching in external rotation

Reverse on load - motor B Motor A ON/OFF Motor B ON/OFF Transport setting Synchronized/ non-synchronized mode Total therapy time Service menu

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2.4 Explanation of symbols (connections and nameplate)

Alternating current

English

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

 Warning!

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®-S3 device. Individuals are authorized after receiving training in the operation of the device and reading this operation manual.

 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.

 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.

 Caution! 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

– Ensure an anatomically correct setup of the CPM device suitable for the patient to be treated. For this purpose, check the following settings/positions (see numbers on device):

 Danger! Explosion hazard - ARTROMOT®-S3 is not designed for use in areas of medical locations where an explosion hazard may occur. An explosion hazard may result from the use of flammable anesthetics, skin cleansing agents and disinfectants.

1

1. Horizontal adduction/abduction 2. Height adjustment 3. Adjustment of upper arm length 4. Adjustment of elbow angle 5. Adjustment of forearm length 6. Adjustment of headrest When the optional patient restraint is used1 7. Adjustment of headrest and shoulder restraint1

Only with ARTROMOT®-S3 comfort

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– It is not permitted to change the adjustment of 1 through 7 while a patient is sitting in the CPM device.

 Warning!

– Movements must not cause any pain or irritation.

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

– Patients must be fully conscious while being instructed in the use of the CPM device and during therapy.

– Before use allow the ARTROMOT®-S3 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 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

– The ARTROMOT®-S3 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.

– The patient must be familiar with the functions of the ARTROMOT®-S3 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.

– 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.

– 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 sections 4.1 and 5.3, paragraph "New Patient"). Use original chip cards only.

– Do not use multiple portable socket outlets (MPSO) to connect the device to the power line. ARTROMOT®-S3 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.

– All accessories used with the ARTROMOT®-S3 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.

– 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®-S3 must be immediately checked by a service technician, before it can be reused. 53

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Shock hazard -

 Warning!

 Caution!

– 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 and radio systems 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.

Equipment malfunction 

Equipment damage 

– The seat withstands a maximum continuous load of 150 kg (330.7 lbs). – 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 ARTROMOT®-S3 device to direct sunlight, because some of the components may reach inadmissibly high temperatures.

− Refer repair and maintenance to authorized persons.

– Be aware that the connectors can only be inserted in the correct orientation and secure all connections with the locks.

– Route all cables such that they will not get caught in the moving parts during operation and that they do not present a stumbling hazard. – Inspect the ARTROMOT®-S3 for damage and loose connections at least once a year.

 Caution! Preventing chafing and pressure sores  When your patient is adipose, very tall or very short, be sure to prevent chafing and pressure sores. Patient hazard, damage to the carriage  Do not use the carriage to transport patients.

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4. Device setup Note: For a better understanding of each step, please fold out pages 3 and 252.

Setup with programmed chip card

4.1 Connecting the device, performance check

Press the START key. The device automatically enters the starting position (maximum adduction, halfway between internal / external rotation).

1. Connect the power cord to socket (6) of the device and the mains plug to a wall outlet with a non-fused earthed wire (100 to 240 Volt, 50/60 Hz).

Performance check

2. Turn the power switch (7) on. 3. Follow these steps to set the carriage to the home position:

If the programming unit can be operated as described above and ARTROMOT®-S3 enters the home position (for home position values, refer to section 5.3), the device has passed the performance check.

Initial adjustment for new patients Write the patient's name down on the back of the chip card. Insert the original patient chip card (2) into the programming unit (1).

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

Press the MENU key on the programming unit three times to access programming level 3 (with each key press, you advance one level).

– An audio signal sounds. – The device switches off immediately. – The message "ERROR" and an error code (e.g. ERROR 5) appear on the display.

Press the "new patient" parameter key and select this function (a check mark appears in the circle next to the function).

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.

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

If it has been determined that the ARTROMOT®-S3 device operates perfectly, ask the patient to sit down on the ARTROMOT®-S3 chair.

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Insert the original patient chip card (2) into the programming unit (1).

• In the next step adjust the headrest1: Height adjustment with locking screw (32), headrest adjustment with locking screw (30), fine adjustment with ball joint (33).

4.2 Adjusting the device to the patient

• Use locking screw (31) to position the shoulder restraint1 approx. 1 cm above the shoulders.

Note! For the following adjustments, the patient's arm should not yet be placed on the armrest. After you have adjusted the device to the approximate patient measurements, the patient can place his/her arm on the armrest for a check of the setup and for the fine adjustment.

• Set the armrest for the healthy arm to a height that allows the patient to sit up straight (locking screw 14).

The settings are numbered 1 through 5. For easy orientation, you will find the same numbers on the CPM device. Always set up the CPM device in this order. Write the settings down on the back of the patient's chip card. Before you adjust the der ARTROMOT®-S3 to the patient, you may have to convert the device for use on the left or right shoulder. (see section 6.4 Conversion)

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

Anatomically correct adjustment

Backrest, headrest, shoulder restraint, armrest Before you start setting up the device for the exercise protocol, you must adjust it to a position that is anatomically correct for the respective patient. • Open thumbscrew (10) and adjust the backrest to a position that is comfortable for the patient. (Fig. F)

1

Only with ARTROMOT®-S3 comfort 56

† Horizontal adduction/abduction

Note!

(Fig. A)

If the elbow angle is changed to a flexion value of greater than or less than 90°, the setting for the upper arm length will have to be changed, too.

It is the purpose of the adjustment procedures to accommodate the patient in the most comfortable position possible.

• Loosen clamping lever (26) and pull out the handle until the forearm can easily be accommodated between elbow support and handle.

ΠHeight adjustment (Fig. B) Before opening locking screw (14), hold the moving part of the CPM device by grasping the holding tube for the length adjustment (17), to prevent the part from falling down.

• Tighten the clamping lever.

Note! The armrest inclination can be adjusted until optimally suited to the arm.

• Adjust the height so that the axis of motor A is level with the pivot of the shoulder joint (see illustration on page 56). The pivot of motor A and the pivot of the shoulder joint must be on the same level.

To do so, loosen the locking screw (28) below the armrest. Adjust the inclination and tighten the locking screw.

• Tighten the locking screw. Checking the setup, fine adjustment

Å Upper arm length (Fig. C) • Place the patient's arm on the armrest.

The device for adjustment of the upper arm length is self-locking. During adjustment, slightly lift motor B and ensure that the insertion tube does not wedge in the holding tube.

• Check adjustments 1 through 5 to ensure that – the pivot of motor A and the pivot of the shoulder joint are on the same level

• Loosen clamping lever (18) and slightly lift the motor during adjustment.

– the axis of motor B, the center of the elbow joint and the center of the shoulder joint form a straight line. To adapt the armrest even better to the patient, you can also adjust its height and inclination. To do so, loosen the locking screw (28) below the armrest.

• Tighten the clamping lever.

è Elbow angle (Fig. D) In most cases an angle of 90° to 60° is adjusted for elbow flexion.

• Check that all locking screws are tightened and all clamping levers properly closed.

• Loosen locking screw (20). To facilitate the adjustment, slightly lift motor B. • Complete the adjustment and tighten the locking screw.

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ì Forearm length (Fig. E)

• Press on the indexing knob (12) and make sure that it locks into place after the adjustment.

5. Setting the treatment values

 Warning!

- the reverse on load setting saved in the "Text" version is automatically used for both motors

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.

- the key lock is disabled.

Patient hazard 

2. If you use a "Text" programming unit with a formatted chipcard of the "Graphics" version, please note the following - the selected language automatically changes to the default setting: German

Note: See also 2.2 and 2.3 as well as page 249!

- the reverse on load setting saved for motor A in the "Graphics" version is automatically used for both motors

Note! Programming is only possible when the patient's chip card has been inserted.

- a key lock set in the "Graphics" version will remain active, because it is irrelevant for the "Text" version.

For information about therapy parameters and programming of special functions, please refer to sections 5.1 to 5.5.

5.1 General information on programming ARTROMOT®-S3

See section 5.6 for programming examples.

Important!

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

The programming unit ARTROMOT®-S3 "Graphics" can be connected to all products of the ARTROMOT® shoulder series with serial numbers 3000 and higher.

2. The treatment parameters and functions are allocated to four (Standard model) or six (Comfort model) 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.

It is possible to exchange chipcards between the "Text" and "Graphics" versions. Please note: 1. If you use a "Graphics" programming unit with a formatted chipcard of the "Text" version, please note the following

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.

- the selected language of the"Text" version remains activated"; it is irrelevant for the "Graphics" version

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

Note!

• The corresponding symbol appears on the display in a larger format. • The symbol above the parameter key appears in reverse video.

- 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.

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

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

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.

Press both keys again to unlock.

• The set value is displayed.

- 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.

5. Having programmed all parameters, press the STOP key to save the values. 6. Then press the START key: ARTROMOT®-S3 checks the set values, moves to the position halfway between the set internal and external rotation values as well as to the set maximum adduction value and stops.

- Emergency stop function: ARTROMOT®-S3 will stop immediately, when any of the keys is pressed during therapy.

7. Press the START key again to start therapy.

Patient treatment can be resumed by pressing the START key. The device will automatically change the direction.

Next the carriage will move the maximum internal rotation value in the synchronized mode. The carriage will then simultaneously move to the maximum external rotation position and the maximum abduction position and subsequently to the maximum adduction position and the maximum internal rotation position. After reaching this position, the cycle restarts: maximum abduction and maximum external rotation.

Patients with a programmed chip card • First complete the mechanical adjustments. • Then insert the chip card (the patient is not yet positioned on the CPM device). • Press the START key: the device will move to the starting position as specified by the parameters stored on the chip card and stops. • Position the patient on the CPM device and press the START key to initiate therapy.

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.

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- Refer to sections 5.3 and 5.5 for a description of the parameters.

5.2 Programming ARTROMOT®-S3 Standard

Note! • While you adjust the 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 pain.

Different programming levels are provided to program the ARTROMOT®-S3 Standard models.

• Special functions can be programmed and retrieved with ARTROMOT®-S3 Comfort devices (see sections 5.4 and 5.5).

You change between levels by pressing the MENU key repeatedly. The display always indicates the currently selected level. The following treatment values, settings and information can be entered/viewed on the programming unit (1):

• The angle entered last for the respective direction of motion will be saved in each case.

5.3 Treatment value details – Standard models

LEVEL 1: - Abduction

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

- Adduction - Internal rotation - External rotation

• The treatment parameters are selected with the different parameter keys.

MENU

• To change the treatment values, press the + / – keys.

LEVEL 2:

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

- Pause - Therapy timer

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

- Speed - New patient

LEVEL 1:

MENU LEVEL 3: - Reverse on load - motor A

■ Abduction Maximum value:

175 degrees

■ Adduction Maximum value:

30 degrees

- Reverse on load - motor B - Motor A ON/OFF - Motor B ON/OFF

 Caution!

MENU

Patient hazard 

LEVEL 4:

When using the shoulder restraint, be sure not to program abduction values greater than 80°.

- Transport setting - Synchronized/ non-synchronized mode - Total therapy time - Service menu

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- 90 degrees

■ External rotation Maximum value:

90 degrees

the carriage will first move to the maximum adduction position and to the position halfway between internal and external rotation. Then the carriage will stop, allowing the patient to be positioned. When the START key is pressed again (start of therapy), the carriage will first move to the maximum internal rotation position. Motor A (abduction/adduction) stops during this procedure. Once the maximum internal rotation position has been reached, both motors (A and B) will simultaneously move to the maximum abduction and external rotation position. After reaching this position, the cycle restarts: maximum adduction and maximum internal rotation.

Note! • The programmed values and the values (degrees) measured on the patient may deviate slightly. • To ensure a physiological motion, the carriage simultaneously moves to the following positions in the synchronized mode: - Maximum abduction value simultaneous with maximum external rotation value

• The elevation movement (flexion) is programmed by means of the abduction/adduction values (for mechanical adjustment instructions, refer to section 5.6 "Examples of use").

- Maximum adduction value simultaneous with maximum internal rotation value • To ensure that the movements you program are physiological in nature, we recommend to program the carriage in the following order:

• Horizontal adduction/abduction is adjusted manually. These are possible settings:

1. Maximum adduction value 2. Maximum internal rotation value 3. External rotation (to relieve the shoulder) = 0°

Horizontal adduction:

120°

Horizontal abduction:

0°

LEVEL 2:

■ Pauses

5. Maximum abduction value

Pauses occur at each programmed maximum value. 6. Maximum external rotation value

These are the two pause points: - Maximum adduction value simultaneous with maximum internal rotation value

• In the synchronized mode, after activation of START

- Maximum abduction value simultaneous with maximum external rotation value Pauses are adjustable in steps of 1 second between 0 and 30 seconds. Default: no pause

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■ Internal rotation Maximum value: