ARTROMOT-E2 and E2 COMPACT Operating Instructions REV 03/03 March 2012

Device description ARTROMOT®-E2

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Figures ARTROMOT®-E2

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Symbol overview ARTROMOT®-E2/-E2 compact

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Figures ARTROMOT®-E2 compact

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Device description ARTROMOT®-E2 compact

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1. How to use the CPM device

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1.1 Fields of application

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1.2 Therapy objectives

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1.3 indications

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1.4 Contraindications

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2. Description of the ARTROMOT®-E2/-E2 compact

1.1 Fields of application

1.3 Indications

The ARTROMOT®-E2/-E2 compact is a motor-operated Continuous Passive Motion (CPM) device providing motion to the elbow joint.

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

1.2 Therapy objectives

− all types of arthoplasty

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2.1 description of the ARTROMOT®-E2 device components

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2.2 description of the ARTROMOT®-E2 compact device components

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2.3 description of the programming unit

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2.4 Explanation of symbols

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2.5 Explanation of symbols (connections and nameplate)

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3. Safety information

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4. Device setup

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Note: See device description on pages II / III and VIII / IX 4.1 Connecting the ARTROMOT®-E2/-E2 compact, performance check

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4.2 Adjusting the device to the patient

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− mobilization of joints in anesthetized patients CPM therapy with the ARTROMOT®-E2/-E2 compact is mainly used to prevent the negative efects 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.

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Other objectives of therapy include:

5.1 General information on programming the ARTROMOT®-E2/-E2 compact

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− improvement of joint metabolism

5.2 Programming the ARTROMOT®-E2/-E2 compact

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− prevention of joint stifness (arthroibrosis)

5.3 Therapy parameter details

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5.4 Application and programming examples

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

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− faster hematoma/luid resorption

5. Setting the treatment values

6. Care, Maintenance, Transport, Conversion 6.1 Care

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6.2 Maintenance (fuse replacement)

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6.3 Transport

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6.4 Conversion

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7. Environmental Protection Statement

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

− exercise-stable fractures after surgery and pseudoarthrosis − endoprosthetic implants − myoplasty − corrective osteotomy

1.4 Contraindications Do NOT use the ARTROMOT®-E2/-E2 compact on patients with:

− acute inlammatory processes in the joints, unless on the order of a physician

− improved lymph and blood circulation − thrombosis and embolism prophylaxis

− spastic paralysis − unstable osteosynthesis

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8. Specifications

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9. IEC 60601-1-2:2007 and IEC 60601-1-11:2010

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9.1 Electromagnetic emissions

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9.2 Electromagnetic immunity

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9.3 Recommended separation distances

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10. Contact

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11. Technical service

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11.1 Technical hotline

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11.2 shipment

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11.3 spare parts

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12. Declaration of conformity

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1. How to use the CPM device

Contents

Pronation/supination

2.2 Description of the ARTROMOT®-E2 compact device components

27. dorsal hand support 28. Folds down the backrest (transport position)

The motorized CPM device supports the following movements of the elbow joint:

2.1 Description of the ARTROMOT®-E2 device components

5° - 0° - 140°

Extension/lexion

26. Palmar hand support

90° - 0° - 90°

29. wheels

Note: See device description on pages VIII and IX

30. bracket for adjustment of the positioning angle 31. strap for upper arm support

it can be reconigured for use on either side.

Note! To unambiguously represent the current position of the CPM device, pronation and extension values below 0° are marked with the symbol “-” both on the display and in this document.

Note: See device description on pages II and III

32. Connector for programming unit

1.

subject to technical modiications (07/2008)

knob for horizontal adduction/ abduction (horizontal extension/ lexion)

1.

3. Cam lever for forearm length adjustment 4. slider 5. Pin for swivel motion of upper arm support

2. screw for double joint 3. double joint

These are some of the outstanding ARTROMOT®-E2/-E2 compact features:

screw for height adjustment

2. screw for elbow angle adjustment

4. screw for height adjustment

6. screw for forearm module swivel motion

5. upper arm support

7. locking screw for right/left positioning

6. locking pin for height adjustment of upper arm support

9. Connectors for motion element

8. Fuse

7. screw for elbow angle adjustment

10. straps for forearm support

− physiological movements

8. Cam lever for forearm length adjustment

11. Motor A

− maximum possible ranges of motion

9. slider

− anatomically correct setup

− programming unit for precise adjustment of patient-speciic therapy values

12. Motor b 13. Palmar hand support

10. screw for adjustment of the backrest angle

− chip card for storage of the programmed therapy parameters − easy transport Biocompatibility Those parts of the ARTROMOT®-E2/-E2 compact that come into contact with the patient when the device is used as intended, are designed to fulil the biocompatibility requirements of the applicable standards.

14. dorsal hand support

11. Pin for swivel motion of upper arm support

15. Programming unit

12. screw for forearm module swivel motion

17. Patient chip card

13. locking screw for right/left positioning

19. Power switch (On/OFF)

14. Armrest for healthy arm

20. upper arm support

15. Programming unit

21. strap for upper arm support

16. Compartment for storage of programming unit

22. wheel locks

16. Connector for programming unit

18. Connection for power cord

17. Patient chip card

23. Compartment for storage of programming unit

18. Connection for power cord

24. locking screw

19. Power switch (On/OFF)

25. wheels

20. Fuse

26. Pin for height adjustment of upper arm support

21. Connectors for motion element

27. bracket for adjustment of the positioning angle

22. locking pins 23. straps for forearm support

subject to technical modiications (07/2008)

24. Motor A 25. Motor b 50

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2. Description of the ARTROMOT®-E2/-E2 compact

2.3 Description of the programming unit

2.3.2 Programming unit in MENU selection mode

2.3.1 Programming unit in normal mode

set carriage angle for extension/lexion

patient chip card

set angle of motor b treatment side, left or right (here: left)

selected therapy protocol

selected MEnu level

selectable parameters and the corresponding selection keys

therapy timer set supination value

set lexion value

set pronation value

set extension value

motor b – selected direction of motion

motor A – selected direction of motion

parameter keys MEnu key

+ (plus) key

sTART key

- (minus) key

sTOP key

2.3.3 Programming unit in ROM programming mode (range of motion) current maximum value selected for lexion or supination (here: lexion)

selected function

set carriage angle for extension/lexion or pronation/supination

selected parameter (here: extension)

set maximum extension/ pronation value (here: extension)

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set angle of motor A

set carriage angle for pronation/supination

2.3.4 Programming unit in general programming mode

2.4 Explanation of symbols

selected functions

status of the selected function (here speed)

extension

stretching in extension

lexion

stretching in lexion

pronation

stretching in pronation

supination

stretching in supination

pause

EROM repeat extension/pronation

timer

EEROM repeat lexion/supination

speed

transport setting

warm-up protocol

new patient

load reversal motor A

synchronized/ non-synchronized mode

load reversal motor b

service menu

motor A On/OFF

motor b On/OFF

isolation program

total therapy time extension/lexion therapy documentation pronation/supination therapy documentation

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Also refer to symbol overview on page V.

IP21

The rating iP21 means: 2 is the level of protection against contact and solid objects The digit 2 means: – Protection from contact: protected from contact with a inger – Protection against foreign object: protected against solid foreign object (diameter of 12.5 mm and greater)

alternating current for serial numbers < 20,000: protection class i equipment. The medical device must be connected to a system with protective earth conductor! for serial numbers > 20,000: protection class ii equipment. The medical device has a double or reinforced insulation.

The iP rating indicates the level of protection and thus the suitability of the device for use under diferent ambient conditions.

1 indicates the degree of protection against water The digit 1 means: protection against vertically falling water drops

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2.5 Explanation of symbols (connections and nameplate)

ARTROMOT®-E2 do not rest or lean on or push the assembled device because it might tip over.

type b applied part

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power switch OFF

To prevent tip-over of the assembled ARTROMOT®-E2 during transport, choose the following settings: 1 a = 0° / 1 b = 270° / 1 c = 0° / 2 = 3 / 3 = 90° / 4 = 0 / 5 = 0

power switch On ARTROMOT®-E2 compact The number next to this factory symbol is the year of manufacture

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To prevent tip-over of the assembled ARTROMOT®-E2 compact during transport, choose the following settings: 1 = nicht zutrefend / 2 = 0 / 3 = 90° / 4 = 0 / 5 = 0

The name next to this factory symbol is the manufacturer

The number next to this symbol is the article reference number

device complies with Council directive 93/42/EEC about medical devices, tested and approved by dQs Medizinprodukte Gmbh

The number next to this symbol is the serial number

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Caution! Observe warnings set forth in operation manual!

Observe Operation Manual

do not dispose with unsorted municipal waste

Protect from moisture

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m Warning!

– 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 irst (see sections 4.1 and 5.3, paragraph „new Patient“). use original chip cards only.

Patient hazard -

Deinitions

Safety information

Read the safety statements before use of the CPM device. The safety statements are classiied as follows:

m Danger! Explosion hazard- The ARTROMOT®-E2/-E2 compact 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 lammable anesthetics, skin cleansing agents and disinfectants.

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

− Ensure an anatomically correct setup of the CPM device suitable for the patient to be treated. Therefore, carefully verify the following settings/ positions: (also refer to the numbers on the device):

− All accessories used with the ARTROMOT®-E2/-E2 compact must be approved by djO Global.

1. horizontal adduction/abduction (horizontal extension/lexion)

– Modiications to the medical device described in this document without the manufacturer‘s written consent is prohibited.

2. height adjustment 3. Adjustment of the positioning angle

– Ensure that the medical device is securely set up on solid ground during use.

4. Adjustment of the forearm length 5. Axis adjustment motor A and motor b

m Warning! indicates a hazard. if not avoided, the hazard can result in death or serious injury.

m Warning! Patient hazard - − Only authorized individuals are allowed to operate the ARTROMOT®-E2/E2 compact. individuals are authorized after receiving training in the operation of the device and reading this operation manual.

m Caution! indicates a potential hazard. if not avoided, the hazard may result in minor injury and/or product/property damage.

− 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, irst 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.

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– 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.

6. backrest adjustment 7. ROM adjustment

− Always seat the patient on a chair with four legs and without armrests when using the ARTROMOT®-E2 compact.

− it is not permitted to change the adjustment of 1 through 6 while the CPM device is applied on a patient. – 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.

m Warning! – Extreme caution should be taken when in use around small children and babies! suicient distance to the device is mandatory for their safety!

– 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 speciic patient.

– never leave the device unattended when it is switched on! switch the device of and disconnect the power line from the wall outlet!

− The patient must be familiar with the functions of the ARTROMOT®-E2/-E2 compact 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.

– After use, store the device in a safe place! Ensure device stability also during storage! do not rest or lean on or push the assembled device because it might tip over.

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3. Safety information

m Warning!

m Warning!

m Caution!

shock hazard -

Equipment malfunction -

Equipment damage -

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

− Magnetic and electrical ields 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, cell phones, etc. 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 ARTROMOT®-E2/-E2 compact must only be operated in dry rooms. − when disconnecting the device from the power line, remove the plug from the wall outlet irst, before disconnecting the cable from the device.

− Refer repair and maintenance to authorized persons. Persons are authorized after training by a specialist trained and commissioned by the manufacturer.

− 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 djO Global, if you have questions in this matter.

− Route all cables such that they will not get caught by the moving parts during operation and that they do not present a stumbling hazard. − Inspect the ARTROMOT®-E2/-E2 compact for damage and loose connections at least once a year.

– do not use multiple portable socket outlets (MPsO) to connect the device to the power line. The ARTROMOT®E2/-E2 compact 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.

m Caution! Preventing chaing and pressure sores - – if your patient is adipose, very tall or very short, be sure to prevent chaing and pressure sores.

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

− The seat withstands a maximum continuous load of 150 kg / 330 lb. − The arm support element withstands a maximum continuous load of 9 kg / 20 lb.

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− Before use allow the ARTROMOT®E2/-E2 compact 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.

− 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®E2/-E2 compact to direct sunlight, because some of the components may reach inadmissibly high temperatures. Furthermore, the device must be set up at a safe distance from radiators to prevent excessive temperature rises. – The presence of children, pets and rodents does not normally impair the functioning of the device. however, avoid contamination of the device by children or animals, from dust and lint, and keep them at a safe distance from the device. The safety statements set forth apply. − be aware that the connectors can only be inserted in the correct orientation and secure all connections with the locks.

m Caution!

– Liquids must not be allowed to enter the CPM device or the programming unit. if liquids have entered into the device, the ARTROMOT®E2/-E2 compact must be checked by a service technician, before it can be reused.

Patient hazard, damage to the CPM device - – The CPM device ARTROMOT®-E2 must not be used to transport people.

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Note: See device description on pages II / III and VIII / IX.

Adjustment with programmed chip card

4.1 Connecting the ARTROMOT®-E2/-E2 compact, performance check

insert the original patient chip card (17) into the programming unit (15). Press the START key. The CPM device automatically moves to the starting position (middle position of the set extension/lexion and pronation/ supination values).

The equipment supplied includes these items: base unit (chair/stand with castors), motion element, programming unit (15), patient chip card (17), arm rest (chair model only - 4), power cord (not shown), operating instructions

Performance check

1. set up the device and connect the required cables by reversing the transport instructions given in section 6.3.

if the programming unit can be operated as described above and the

2. Follow these steps to set the carriage to the home position:

ARTROMOT®-E2/-E2 compact moves to the home position (for home position values, please refer to sections 5.3), the CPM device has passed the performance check.

Initial adjustment for new patients

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

write the patient’s name down on the back of the chip card. insert the original patient chip card (17) into the programming unit (15).

− An audio signal sounds.

4.2 Adjusting the device to the patient

• Only use chairs with four legs and without armrests. The patient must be seated safely and straight on the chair.

Note!

• Once you have set up the ARTROMOT®E2 compact, lock the brakes (22) of the castor wheels (25).

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 ine adjustment.

4.2.1 Adjusting the ARTROMOT®-E2 to the patient Note: The individual steps are illustrated on page IV.

The settings are numbered 1 through 5. For easy orientation, you will ind the same numbers on the CPM device. Always set up the CPM device in this order.

@ a,b and c Horizontal Extension/Flexion (Fig. A)

write the settings down on the back of the patient‘s chip card. before you adjust the ARTROMOT®E2/-E2 compact to the patient, you may have to convert the device for use on the left or right elbow joint. (see section 6.4 Conversion)

horizontal adduction/abduction is set manually. it is the purpose of the adjustment to achieve congruent axes of the motor axis and the elbow joint.

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

• now open screw (2). The double joint now moves freely.

ARTROMOT®-E2: backrest, armrest

• set the motion element with motor A to the appropriate position. Make sure that a congruence of the axis of motor A and the elbow joint is achieved.

• To begin with, press knob (1). leave it engaged in the open position.

− The device switches of immediately.

Press the MENU key on the programming unit seven times in rapid succession or give it one long press to access programming level seven (with each key press, you advance one level).

− The message “ERROR” and an error code (e.g. ERROR 5) appear on the display. in this situation, you may attempt to restart the unit by turning it briely of and on again with the power switch. with the unit switched of, check that all plugs are correctly connected. switch the unit on again: if the error message persists, have the unit inspected by a service technician, before using it again.

Press the “new patient” parameter key and select this function (a check mark appears in the circle next to the function). Press the START key. The CPM device automatically enters the home position.

if it has been determined that the ARTROMOT®-E2/-E2 compact operates perfectly, ask the patient to sit down on the ARTROMOT®-E2/-E2 compact chair.

• Push knob (1) in the opposite direction. 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.

• Tighten screw (2).

; Height adjustment (Fig. B)

• Open thumbscrew (10) and adjust the backrest to a position that is comfortable for the patient (Fig. F).

before opening locking screw (4), hold the moving part of the CPM device by grasping the double joint (3), to prevent the part from falling down.

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

• Open screw (4) and set the motion element to the appropriate height. Ensure that the entire upper arm lies on the support (5). The patient should sit up straight and be relaxed.

ARTROMOT®-E2 compact: positioning the chair and the CPM device

• Tighten screw (4). • now check the agreement of the axis of motor A and the elbow joint. if required, make a ine adjustment of the vertical orientation, using locking pin (6).

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. 62

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4. Device setup

abduction. To do so, open adjusting screw (10), set the backrest to the foremost position and tighten the screw.

m Caution!

To achieve optimal congruence between the axis of motor A and the patient’s rotational axis of the elbow joint, the backrest angle can be individually adjusted in all other horizontal adduction/abduction positions.

Patient hazard / equipment damage - Hold motor B for this adjustment to secure the device.

Checking the setup, ine adjustment

• hold the motion element at bracket (30). • now open screw (7) and set the appropriate angle.

Please check the following before using the CPM device on a patient:

• Tighten screw (7).

• Check settings 1 to 6 and make sure that the pivot of motor A agrees with the pivot of the elbow joint, i.e., that the axis of motor b vertically passes through the elbow joint.

% Adjustment of the forearm length (Fig. D)

• Check that all locking screws and clamping levers are tight.

m Caution! Patient hazard / equipment damage -

4.2.2 Adjusting the ARTROMOT®-E2 compact to the patient

Hold motor B for this adjustment to secure the device. • Open the cam lever (8) and set the appropriate length. Make sure that the slider (9) is free to move at least 2 cm in either direction. There must be enough space for the ingers between the hand support and motor b.

& Axis adjustment motor B (Fig. D)

; Height adjustment (Fig. A) before opening locking screw (1), hold the moving part of the CPM device by grasping motor A (11), to prevent the part from falling down.

in most cases the setting is 0 on the scale. in cases of a deformed forearm, the setting may have to be changed.

• Open screw (1) and set the motion element to the appropriate height. Ensure that the entire upper arm lies on the support (20). The patient should sit up straight and be relaxed.

• Open the locking screw (7) and perform the adjustment.

• Tighten screw (1).

Checking the setup, ine adjustment

• Tighten the locking screw (7).

• now check the agreement of the axis of motor A and the elbow joint. if required, make a ine adjustment of the vertical orientation, using locking pin (26).

Please check the following before using the CPM device on a patient:

= Adjustment of the positioning angle (Fig. B).

• Check settings 2 to 5 and make sure that the pivot of motor A agrees with the pivot of the elbow joint, i.e., that the axis of motor b vertically passes through the elbow joint.

m Caution!

• Check that all locking screws and clamping levers are tight.

Patient hazard / equipment damage - Hold motor B for this adjustment to secure the device.

Note: The individual steps are illustrated on page 85.

• hold the motion element at bracket (27).

Note: Step 1 does not exist for the ARTROMOT®-E2 compact.

• now open screw (2) and set the appropriate angle. • Tighten screw (2).

• Tighten the cam lever (8).

% Adjustment of the forearm length (Fig. C)

& Axis adjustment motor B (Fig. E)

m Caution!

in most cases the setting is 0 on the scale. in cases of a deformed forearm, the setting may have to be changed.

Patient hazard / equipment damage - Hold motor B for this adjustment to secure the device.

• Open the locking screw (13) and perform the adjustment. • Tighten the locking screw (13).

• Open the cam lever (3) and set the appropriate length. Make sure that the slider (4) is free to move at least 2 cm in either direction. There must be enough space for the ingers between the hand support and motor b.

( Backrest adjustment (Fig. F) set the backrest to the foremost position before setting the motion element to an angle of 0° for horizontal adduction/

• Tighten the cam lever (3).

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= Adjustment of the positioning angle (Fig. C)

• The set value is displayed.

m Warning!

2. if a “Text” programming unit is operating with a formatted “Graphics” chip card

Patient hazard - 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 selected language automatically changes to the default setting: German. − the reverse on load setting saved for motor A in the “Graphics” version is automatically used for both motors. − a key lock set in the “Graphics” version will remain active, only when no changes were made with the “Text” version; the key lock function is not an option with the “Text” version.

Note: See also 2.2 and 2.3

Note! Programming is only possible when the patient‘s chip card has been inserted. For information about therapy parameters and programming of special functions, please refer to sections 5.1 to 5.3.

5.1 General information on programming the ARTROMOT®-E2/ -E2 compact

see section 5.4 for programming examples.

Important!

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

The programming unit ARTROMOT®-E2/-E2 compact “Graphics” can be connected to all products of the ARTROMOT® family of elbow CPM machines.

2. The treatment parameters and functions are allocated to seven programming levels (four functions 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 brief key press you advance one level. The code M1, M2, etc. that appears in the middle of the display indicates the programming level. To back up one level, e.g. from level 2 to 1 or from level 1 to 7, hold the MEnu key down for some seconds.

it is possible to exchange chip cards between the “Text” and “Graphics” versions. Please note: 1. if a “Graphics” programming unit is operating with a formatted “Text” chip card − the selected language of the “Text” version remains activated; it is irrelevant for the “Graphics” version.

Note!

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

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

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.

− 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.

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 identiied with a check mark in the circle next to the symbol.

− To prevent accidental changes of the parameter settings, you can lock the keys. To do so, simultaneously press keys + and – for approx. 3 seconds.

5. having programmed all parameters, press the STOP key to save the values. Press both keys again for approx. 3 seconds to unlock.

6. Then press the START key: the ARTROMOT®-E2/-E2 compact checks the set values, moves to the position halfway between the set extension and lexion values as well as to the set supination and pronation values and stops.

− selecting the “new patient” function will automatically delete the data on the patient chip card. when you have inished programming the unit and press the STOP key, the settings will automatically also be saved to the patient chip card.

7. Press the START key again to start therapy. The CPM device will now begin with the set physiological motion pattern in the synchronized mode. The motor with the larger range of motion operates at the programmed speed, while the speed of the second motor is adapted. This ensures that both motors will reach their target positions at almost the same time.

− Emergency stop function: when any of the keys is pressed during therapy, the ARTROMOT®-E2/-E2 compact switches immediately of. – when the START key is pressed again in the synchronized mode and in the non-synchronized mode, the carriage will reverse its direction.

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. The programmed speed is valid for both motors.

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).

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 reverse on load setting saved in the “Text” version is automatically used for both motors.

• Press the START key: the device will move to the starting position as speciied 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.

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

− the key lock is disabled.

• The corresponding symbol appears on the display in a larger format. 66

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5. Setting the treatment values

diferent programming levels are provided to program the ARTROMOT®-E2/-E2 compact. You change between levels by pressing the MENU key repeatedly. The currently selected level is indicated on the display.

− therapy documentation: extension/lexion

5.3 Therapy parameter details

− therapy documentation: pronation/supination

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

LEVEL 5:

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

− stretching in extension

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

− stretching in lexion

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

− stretching in pronation

The following treatment values, settings and information can be entered/viewed on the programming unit (15):

− stretching in supination

LEVEL 6: LEVEL 1:

− EROM repeat extension/ pronation

− extension

− EROM repeat lexion/supination

− lexion − pronation

LEVEL 7:

− supination

− transport setting

n extension maximum value:

- 5 degrees

n lexion maximum value:

140 degrees

n pronation maximum value:

− pause − therapy timer

− operating mode synchronized/ non-synchronized

n supination maximum value:

− speed

− service menu

LEVEL 3:

• 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 any pain.

− reverse on load - motor A − reverse on load - motor b

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

− motor A On/OFF − motor b On/OFF

2. maximum pronation value 3. supination = 0° (to relieve the elbow) 5. maximum lexion value 6. maximum supination value • when the START key is pressed in the synchronized mode, the carriage will irst move to the position halfway between the set maximum extension/ lexion values as well as the pronation/supination values. The carriage will stop in this position. Treatment begins when you press the START key again.

LEVEL 1:

− new patient

Note!

1. maximum extension value

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

LEVEL 2:

− warm-up protocol

• To ensure that the movements you program are physiological in nature, we recommend to program the carriage in the following order:

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5.2 Programming the ARTROMOT®-E2/ -E2 compact

• horizontal adduction/abduction is adjusted manually. These are possible settings: - 90 degrees

horizontal adduction:

120°

horizontal abduction:

0°

90 degrees

LEVEL 2:

Note! n Pauses

• The programmed values and the values (degrees) measured on the patient may deviate slightly.

Pauses occur at each programmed maximum value.

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

These are the two pause points: − maximum extension value and maximum pronation value

− maximum extension value and maximum pronation value

− maximum lexion value and maximum supination value.

− maximum lexion value and maximum supination value.

Pauses are separately adjustable for motor A and motor b between 1 second and 60 minutes. Pauses can be set in steps of 1 second to any value between 0 and 59 seconds, and in steps of 1 minute to any value between 1 and 60 minutes.

LEVEL 4: − isolation protocol − total therapy time

Default: no pause 68

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• Access menu level 2, then press the parameter key to select the special . function

Default setting is continuous operation. A clock symbol in the upper right-hand corner of the display identiies the continuous mode of operation. The clock indicates the elapsed therapy time.

• The display shows the symbol for the special function and the selected pause durations.

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

The display shows the symbol for the special function and the selected pause durations. top: lexion/supination pause (

however, the therapy timer can be set in steps of 1 minute to any value between 1 and 59 minutes and in steps of 30 minutes to any value between 1 and 24 hours. when the time has elapsed, the device switches automatically of and stops in the middle between the set limit values.

).

bottom: extension/pronation pause ). ( The lexion/supination pause duration appears in a box.

in this case, a circle replaces the clock symbol. The circle ills as the therapy time progresses.

• To change the lexion/supination pause, press the “+” or “-” key. select a duration of 10 seconds, for instance.

n Speed The speed can be adjusted between 1 % and 100 % in steps of 1 %. 1 % is equivalent to 14°/minute 100 % is equivalent to 230°/minute Default: 100 %

n Motor A ON/OFF

LEVEL 3:

To permit fully isolated movements, the motors can individually be turned on and of. Motor A efects the extension and lexion movements, while motor b efects the pronation and supination movements.

n Reverse on load - motor A (safety feature) The device automatically reverses both motors when the patient’s resistance (load) exceeds the set value.

For an isolated pronation/supination movement, set motor A to the appropriate position (extension/lexion), then turn the motor of.

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

in normal mode the display indicates the symbol “OFF” during therapy, instead of the programmed extension/lexion angles.

Default: level 25 n Reverse on load - motor B (safety setting)

Default: motor A ON n Motor B ON/OFF

The device automatically reverses both motors when the patient’s resistance (load) exceeds the set value.

To permit fully isolated movements, the motors can individually be turned on and of. Motor A efects the extension and lexion movements, while motor b efects the pronation and supination movements.

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

For an isolated extension/lexion movement, set motor b to the appropriate position (pronation/supination), then turn the motor of.

Default: level 25 • Press the parameter key again when done. The frame automatically moves to the line below, indicating that the can extension/pronation pause be adjusted.

n Warm-up protocol during warm-up, the patient will slowly become used to the set maximum values for extension/lexion and pronation/ supination.

The parameter key is only used to toggle between these two functions.

The warm-up protocol starts in the middle between the two maximum values set for extension/lexion and pronation/supination. The range of motion increases with each cycle, until the programmed maximum values are reached after a total of 15 cycles.

• To modify the value, press the “+” (plus) or “-” (minus) key. select a duration of 5 seconds, for instance.

in normal mode the display indicates the symbol “OFF” during therapy, instead of the programmed pronation/supination angles.

m 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.

Default: motor B ON

Note! Please note that one motor (A or b) must always be turned on. Otherwise the following symbol will be displayed when you press START:

After reaching the maximum values, the device automatically enters the normal mode. if a therapy time is activated, the system restarts with the warm-up protocol when the therapy time has elapsed and the devices is started again.

• save the programmed values by pressing the STOP key, then press the START key to initiate the treatment.

LEVEL 4: n Isolation protocol

during warm-up, the display will show in the upper, leftthe symbol hand corner.

For this special function, both motors are turned on, but they will never move simultaneously.

Default: disabled

These are the steps of the function: • To begin with, motor A moves to the

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n Therapy timer

Follow these steps to program pauses:

• To modify the value, press the “+” (plus) or “-” (minus) key. select 75 %, for instance. • Press the parameter key again when done. The marking automatically moves to the lower box, allowing you to adjust the stop position of motor b.

• Then motor b will move to the programmed maximum values for pronation and supination for one cycle and stops, then the full cycle will start over with motor A. Motor A is disabled while motor b is operating (symbol for motor A: OFF)

• To modify the value, press the “+” (plus) or “-” (minus) key. select 25 %, for instance.

• The stop position at the end of the last cycle (for both extension/lexion and pronation/supination) can be selected in steps of 25% between 0% and 100% of the programmed maximum range of motion.

• save the programmed values by pressing the STOP key, then press the START key to begin the treatment.

• steps 1 and 2 can be repeated as often as needed. You can stop treatment with the sTOP key; after the programmed therapy duration, it will stop automatically.

n Total therapy time

LEVEL 5:

under menu item “total therapy time” you can view each patient’s total therapy time (duration of all the patient’s therapy sessions).

n Stretching in extension with the special “stretching in extension” function the joint will be gently stretched (arm stretching movement). Only the extension/lexion movement is treated here. Motor b is automatically disabled. The position of motor b cannot be changed once this special function has been activated.

Deleting the stored therapy time: Press and hold the parameter key for 5 seconds or select the “new patient” function. n Extension/lexion therapy documentation

starting at the middle position the carriage will irst move to the programmed lexion limit and then to the programmed extension limit.

This is a special function of the ARTROMOT®-E2/-E2 compact which allows the entire therapy documentation to be represented.

subsequently the carriage reverses 5 ° towards lexion and then moves very slowly back to the programmed exten). subsequently sion value (symbol: the carriage attempts to attain another ). 5 ° at an even slower speed (symbol:

The carriage run times as well as the range of motion of the sessions are recorded.

during warm-up, the display will show in the upper, leftthe symbol hand corner.

This is what happens: Extension/lexion is treated three times irst (motor A). Motor b is positioned at 25 % of the programmed range of motion for pronation and supination.

Default: disabled Follow these steps to program the special function:

subsequently, pronation/supination is treated once (motor b). Motor A is positioned at 75 % of the programmed range of motion for extension and lexion.

• Access menu level 4, then press the parameter key to select the special func. tion The display will indicate:

Note!

- the symbol representing the special function

The percentage values can be modiied only when the special function is enabled (check mark).

- the status of the special function (circle with or without check mark)

The collected data are presented graphically in the form of a coordinate system (X-axis = range of motion / Y-axis = time) where the upper curve illustrates the trend of the lexion movement and the lower curve the trend of the extension movement.

if a high resistance toward the additional 5 ° is sensed, the reverse on load function is automatically activated and the carriage moves in the opposite direction. This stretch cycle is repeated ten times.

n Pronation/supination therapy documentation

After that the carriage moves to the programmed lexion limit and restarts the stretching in extension cycle.

This is a special function of the ARTROMOT®-E2/-E2 compact which allows the entire therapy documentation to be represented.

This sequence can be repeated as often as needed. You can stop treatment with the sTOP key; after the programmed therapy duration, it will stop automatically.

The carriage run times as well as the range of motion of the sessions are recorded.

Default: disabled

The collected data are presented graphically in the form of a coordinate system (X-axis = range of motion / Y-axis = time) where the upper curve illustrates the trend of the supination movement and the lower curve the trend of the pronation movement.

- two boxes with the current percentage of the stop positions for motor A and b - a check mark in a circle. • You activate the function with the “+” key and deactivate it with the “-” key. in this case it is not possible to activate/ deactive the function by pressing the parameter key again. A check mark in the circle identiies the activated function. • next press the parameter key of the isolation protocol. The marking moves to the upper percentage value, allowing you to enter the stop position for motor A. 72

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programmed maximum values for extension and lexion for three cycles and then stops. in this phase, motor b is disabled (symbol for motor b: OFF)

Note!

Note!

Note!

• if a pause has been programmed, the carriage will stop for the pause each time the maximum stretching value is attained.

• if a pause has been programmed, the carriage will stop for the pause each time the maximum stretching value is attained.

• if a pause has been programmed, the carriage will stop for the pause each time the maximum stretching value is attained.

• if a pause has been programmed, the carriage will stop for the pause each time the maximum stretching value is attained.

• Enabling the stretching in extension function automatically disables motor b. The only movement performed is extension/lexion.

• Enabling the stretching in lexion function automatically disables motor b. The only movement performed is extension/lexion.

• Enabling the stretching in pronation function automatically disables motor A. The only movement performed is pronation/supination.

• Enabling the stretching in supination function automatically disables motor A. The only movement performed is pronation/supination.

• it is not possible to combine a second stretching function with the special function „stretching in extension“.

• it is not possible to combine a second stretching function with the special function “stretching in extension”.

• it is not possible to combine a second stretching function with the special function “stretching in pronation”.

• it is not possible to combine a second stretching function with the special function “stretching in supination”.

• during operation, the display will in the upper, show the symbol left-hand corner.

• during operation, the display will in the upper, show the symbol left-hand corner.

• during operation, the display will in the upper, show the symbol left-hand corner.

• during operation, the display will in the upper, show the symbol left-hand corner.

n Stretching in lexion

n Stretching in pronation

n Stretching in supination

with the special “stretching in lexion” function the joint will be gently stretched (arm bending movement). Only the extension/lexion movement is treated here. Motor b is automatically disabled. The position of motor b cannot be changed once this special function has been activated.

with the special “stretching in pronation” function the joint will be gently stretched in the pronation direction. Only the pronation/supination movement is treated here. Motor A is automatically disabled. The position of motor A cannot be changed once this special function has been activated.

with the special “stretching in supination” function the joint will be gently stretched in the supination direction. Only the pronation/supination movement is treated here. Motor A is automatically disabled. The position of motor A cannot be changed once this special function has been activated.

starting at the middle position the carriage will irst move to the programmed extension limit and then to the programmed lexion limit.

starting at the middle position the carriage will irst move to the programmed supination position and then to the programmed pronation position.

starting at the middle position the carriage will irst move to the programmed pronation position and then to the programmed supination position.

subsequently the carriage reverses 5 ° towards extension and then moves very slowly back to the programmed lexion ). Then the carriage value (symbol: attempts to attain another 5 ° at an ). even slower speed (symbol:

subsequently the carriage reverses 5 ° towards supination and then moves very slowly back to the programmed prona). subsequently tion value (symbol: the carriage attempts to attain another 5 ° at an even slower speed (symbol: ).

subsequently the carriage reverses 5 ° towards pronation and then moves very slowly back to the programmed supina). subsequently tion value (symbol: the carriage attempts to attain another 5 ° at an even slower speed (symbol: ).

if a high resistance toward the additional 5 ° is sensed, the reverse on load function is automatically activated and the carriage moves in the opposite direction.

if a high resistance toward the additional 5 ° is sensed, the reverse on load function is automatically activated and the carriage moves in the opposite direction.

if a high resistance toward the additional 5 ° is sensed, the reverse on load function is automatically activated and the carriage moves in the opposite direction.

This stretch cycle is repeated ten times.

This stretch cycle is repeated ten times.

This stretch cycle is repeated ten times.

After that the carriage moves to the programmed extension limit and restarts the stretching in lexion cycle.

After that the carriage moves to the programmed maximum supination position and restarts the stretching in pronation cycle.

After that the carriage moves to the programmed maximum pronation position and restarts the stretching in supination cycle.

This sequence can be repeated as often as needed. You can stop treatment with the STOP key; after the programmed therapy duration, it will stop automatically.

This sequence can be repeated as often as needed. You can stop treatment with the STOP key; after the programmed therapy duration, it will stop automatically.

Default: disabled

Default: disabled

This sequence can be repeated as often as needed. You can stop treatment with the STOP key; after the programmed therapy duration, it will stop automatically. Default: disabled

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Note!

n EROM repeat extension/pronation The special “EROM repeat extension/ pronation” function allows a more eficient exercise in the last 10 ° before the set maximum extension and pronation values. For this protocol, the CPM device starts in the middle between the set maximum extension/lexion and pronation/supination values. First of all the carriage moves simultaneously to the maximum lexion angle and to the maximum supination angle. Then it moves simultaneously to the maximum extension angle and to the maximum pronation angle.

when the lexion/supination value has been reached, the carriage reverses 10 ° toward extension/pronation and then moves back again to the maximum lexion/supination angle. The movement through the inal 10 ° is repeated ive times at a slow speed.

• pronation:

-5°

• supination:

5°

• pauses:

0

At the end of the cycle, the carriage will again move to the maximum extension value, at the same time as the maximum pronation value, and then starts another cycle with ive repetitions through the last 10 ° of lexion/supination.

• reverse on load motor A: 25

This sequence can be repeated as often as needed. You can stop treatment with the STOP key; after the programmed therapy duration, it will stop automatically. Default: disabled

when the set extension/pronation value has been reached, the carriage reverses 10 ° toward lexion/supination and then moves back again to the maximum extension/pronation angle. The movement through the inal 10 ° is repeated ive times at a slow speed.

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 (also refer to display you will see chapter 6 Transport). n New patient with this function, the CPM device will move to the home position.

Default: disabled

• select the function and press the sTART key:

n EROM repeat lexion/supination

- The carriage moves to the home position. - The programmed treatment parameters are deleted.

The special “EROM repeat lexion/supination” function allows a more eicient exercise in the last 10 ° before the set maximum lexion and supination values.

- All values stored on the chip card are deleted.

For this protocol, the CPM device starts in the middle between the set maximum extension/lexion and pronation/supination values. First of all the carriage moves simultaneously to the maximum extension angle and to the maximum pronation angle. Then it moves simultaneously to the maximum lexion angle and to the maximum supination angle.

- The carriage stops in the middle position of the extension/lexion and pronation/supination angles. The “new patient” function (home position) selects the following settings:

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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.

continuous operation

• speed:

100 %

• reverse on load motor b: 25 • motor A:

On

• motor b:

On

• synchronized mode:

On

• total therapy time:

0

• special functions:

disabled

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

n Operating mode synchronized/non-synchronized

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

synchronized:

n Transport setting

This sequence can be repeated as often as needed. You can stop treatment with the STOP key; after the programmed therapy duration, it will stop automatically.

Patient hazard -

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

LEVEL 7:

At the end of the cycle, the carriage will again move to the maximum lexion value, at the same time as the maximum supination value, and then starts another cycle with ive repetitions through the last 10 ° of extension/pronation.

• timer:

m Caution!

• extension:

25°

• lexion:

35°

Motors A and b perform a synchronized movement according to the elbow joint’s physiological motion pattern:

5.4 Application and programming examples

starting at the middle position of the set extension/lexion and pronation/ supination angles, the carriage irst moves simultaneously to the maximum extension value and the maximum pronation value. Afterwards it moves simultaneously to the maximum lexion and maximum supination values. After reaching this position, the cycle restarts: maximum extension and maximum pronation.

5.4.1 Isolated extension/ lexion 1. Complete the mechanical settings and adjust the carriage to the patient as described in section 4.2. 2. Press the MENU key on the programming unit to access level 1 (M1).

during operation the synchronized mode is indicated in the top left-hand . corner by the symbol

) or supina3. Press the pronation ( ), the press tion parameter key ( the + / - keys to set the carriage to the appropriate rotation position to be maintained during the isolated extension/lexion movements.

non-synchronized: both motors run independently of each other within the selected ranges of motion.

4. next set the desired range of motion for extension/lexion by irst pressing the ), then extension parameter key ( set the values with the + / - keys.

To enable the non-synchronized mode, disable the synchronized mode.

5. set the lexion value ( way.

during operation the non-synchronized mode is indicated in the top left-hand . corner by the symbol Default: synchronized mode enabled

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) in the same

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LEVEL 6:

Note!

Note!

6. Care, Maintenance, Transport, Conversion

• For an exclusive extension/lexion protocol, motor b for the rotation movement must be turned of as described in steps 6 through 8 below.

• For an exclusive rotation protocol, motor A for extension/lexion must be turned of as described in steps 6 through 8 below.

6.1 Care

• having programmed the ranges of motion, you can program additional options, such as pause or speed.

• having programmed the ranges of motion, you can program additional options, such as pause or speed.

6. Press the MENU key on the programming unit to access level 3 (M3).

6. Press the MENU key on the programming unit to access level 3 (M3).

7. Press the Motor B ON/OFF parameter ) to activate the parameter. key (

7. Press the Motor A ON/OFF parameter ) to activate the parameter. key (

8. deactivate motor b by pressing the parameter key Motor B ON/OFF again or the – (minus) key. The check mark in the circle next to the symbol must have disappeared.

8. deactivate motor A by pressing the parameter key Motor A ON/OFF again or the – (minus) key. The check mark in the circle next to the symbol must have disappeared.

9. save the settings with the STOP key, set the carriage to the starting position with the START key and initiate therapy by pressing the START key again.

9. save the settings with the STOP key, set the carriage to the starting position with the START key and initiate therapy by pressing the START key again.

5.4.2 Isolated pronation/ supination

m Caution! − 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.

m Warning! shock hazard – unplug the device from the power line before cleaning. shock hazard, equipment damage – liquids must not enter the device or the programming unit.

− use only clear disinfectants to prevent discoloration of the device. − do not expose the CPM device to strong ultraviolet radiation (sunlight) and ire.

• The ARTROMOT®-E2/-E2 compact can be disinfected by wiping down with a disinfectant. Thus, it complies with the special hygiene standards for medical technical equipment.

6.2 Maintenance (fuse replacement)

• The enclosure and removable support assemblies can be cleaned with commonly used disinfectants and mild household detergents.

Check before each use

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

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

m Warning!

1. Complete the mechanical settings and adjust the carriage to the patient as described in section 4.2.

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.

Patient hazard – patient contamination

2. Press the MENU key on the programming unit to access level 1 (M1).

– before using the device on another patient, be sure to clean and disinfect it according to the instructions given here.

3. Activate the parameter key exten) or lexion ( ), then press sion ( the + / - keys to set the carriage to the appropriate position to be maintained during the isolated pronation/supination movements. 4. next set the desired range of motion for pronation/supination by irst pressing ), the pronation parameter key ( then set the values with the + / – keys. 5. set the supination value ( same way.

) in the

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Equipment damage –

Fuse replacement

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.

m Warning!

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 staf.

The replacement of fuses must be referred to specialists as deined in iEC 60364 or other applicable standards (e.g. biomedical technicians, electricians, electronics installers).

Patient hazard, equipment malfunction and damage -

Fuses used must be T1A H250Vac fuses.

m Warning! Patient hazard, equipment malfunction and damage – Refer repair and maintenance to authorized persons. Persons are authorized after training by a specialist trained and commissioned by the manufacturer. ORMEd Gmbh will make all documents required for servicing, such as circuit diagrams, parts lists, descriptions or calibration instructions, available to authorized experts.

6.3.1 ARTROMOT®-E2 The following operating steps must be completed before transporting the ARTROMOT®-E2: 1.

Activate the “transport setting” funcin the menu (see also 5.3) tion and start the ARTROMOT®-E2.

2.

Turn of the ARTROMOT®-E2 power switch (19).

3.

Remove the power cord (18) and disconnect the motion element (21) and the programming unit (32).

• before replacing fuses turn of the ARTROMOT®-E2/-E2 compact and remove the power cord from the wall outlet.

4.

Open locking screw (4) and pull out the armrest (14) for the healthy arm.

5.

• use an appropriate tool to remove the fuse holder (20/8) situated between the power switch (19) and the power connector (18) (Fig. 1).

Grasping the motion element at the bracket (30) for adjustment of the positioning angle, open the locking screw (4) and pull out the motion element.

6.

set horizontal adduction/abduction to 0° (indexing knob 1).

7.

Open the locking screw for adjustment of the backrest (10), fold the backrest to the front all the way until lat on the seat and tighten the screw.

8.

Remove the two locking pins (22). Pull out the legs towards the sides, reverse and reinsert. Then put the locking pins back in place.

• Replace the fuses and reinsert the fuse holder (Fig. 2). Check that the fuse holder locks properly into place.

The inspections can be carried out by djO Global Technical service within the framework of a service agreement.

10. Place the ARTROMOT®-E2 - legs irst - on the bottom of the box. The markings on the bottom of the box indicate the correct position.

6.3 Transport

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Technical inspections

11.

Then put the enclosed polystyrene block on the chair, observing the cutouts in the block.

12. Put the programming unit (15) in the supplied box. Place the motion element, the armrest and the power cord in the respective cut-outs in the polystyrene block of the package.

13. Then close the box. Reverse the above steps to reassemble the device after transport.

The device does not require additional regular maintenance.

m Warning!

Fig. 1

shock hazard -

9.

Allow the ARTROMOT®-E2 to reach room temperature before use. 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.

Only use the original shipping box for transporting the device. Ormed Gmbh cannot be held liable for transport damage, if the device was not shipped in its original shipping box.

Fig. 2

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12. Put the programming unit (15) in the supplied box, using suicient padding.

6.3.2 ARTROMOT®-E2 compact The following operating steps must be completed before transporting the ARTROMOT®-E2 compact:

15. Please put the motion element, the power cord and the three smaller boxes in the respective cut-outs of the polystyrene block.

1. Activate the “transport setting” funcin the menu (see also tion 5.3) and start the ARTROMOT®-E2 compact.

3. Remove the power cord (18) and disconnect the motion element (9) and the programming unit (16).

13. Pack the following items in the longer box provided, again using suicient padding:

4. Remove pin (26) on the underside and take of the upper arm support.

• Oval tube of the motion element

• upper arm support

5. Remove pin (5) and take of the swiveling mechanism of the upper arm support. set the guide of the upper arm support to the transport setting (parallel with motor A).

• Column with electronics box • Entire forearm support with slider and hand support

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2. Turn of the ARTROMOT®-E2 compact power switch (19).

16. Then close the box.

m Warning! shock hazard - Allow the ARTROMOT®-E2 compact to reach room temperature before use. 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.

6. Grasping the motion element at the bracket (27) for adjustment of the positioning angle, open the locking screw (1) and pull out the motion element. 7. Open the locking screw for adjustment of the elbow angle adjustment (2) and separate the oval tube from the motion element. 8. Open locking screw (24) on the underside of the stand, then remove the column with the electronics box from the star-shaped stand.

14. Pack the following items in the shorter box provided, again using suicient padding:

9. disassemble the stand by loosening the ive legs with the special tool supplied and remove them.

• star-shaped stand

10. unscrew the locking screw (7) from motor b (12), remove the entire forearm support including the slider (4) and the hand support (13 + 14). Afterwards screw the locking screw (7) back into motor b.

• 5 screws to attach the legs

• 5 legs with castors

• 5 washers to attach the legs • 1 Allen key

11. Only use the original shipping box for transporting the device. Ormed Gmbh cannot be held liable for transport damage, if the device was not shipped in its original shipping box.

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Note!

5. Remove the motion element and insert it on the opposite side. Tighten the locking screw (4). (see conversion diagram 1 b, c).

On the display the respective sides are indicated as follows: –

The CPM device (upper arm support) is prepared for the left elbow.

–

The CPM device (upper arm support) is prepared for the right elbow.

–

6. Pull the pin for the swiveling movement of the upper arm support (11) downward and swing the support 180° towards the inside. Attention: Release the pin (11) while the support is swinging; you will hear it lock into place on the other side (see conversion diagram 2 d)

This symbol appears during conversion of the CPM device.

7. Open the locking screw for the swiveling movement of the forearm support (12) and swing the support with motor b 180°. Tighten locking screw (12) (see conversion diagram 2 e).

6.4.1 Reconiguration of the ARTROMOT®-E2 The ARTROMOT®-E2 can be used on the left and on the right elbow joint. however, the device must be converted irst. This is done very quickly.

8. Open the locking screw for right/left positioning (13) two revolutions. Move the forearm support to the lower recess in the slot and turn it 180° in this position. Then move the forearm support back to the middle position (setting 0) and tighten locking screw (13) again (see conversion diagram 3 f).

1. Activate the “transport setting” function in the menu (see also 5.3) and start the ARTROMOT®-E2. 2. Adjust an angle of 90° for horizontal adduction/abduction (indexing knob 1) (see conversion drawing 1). 3. Open locking screw (4) for the height adjustment, remove the armrest for the healthy arm and place it on the seat (see conversion diagram 1).

Attention: Release the pin (5) while the support is swinging; you will hear it lock into place on the other side (see conversion diagram 1 a).

6.4.2 Reconiguration of the ARTROMOT®-E2 compact

4. Open the locking screw for the swiveling movement of the forearm support (6) and swing the support with motor b 180°.

The ARTROMOT®-E2 compact can be used on the left and on the right elbow joint. however, the device must be converted irst. This is done very quickly.

Tighten locking screw (6) (see conversion diagram 1 b).

1. Activate the “transport setting” function in the menu (see also 5.3) and start the ARTROMOT®-E2 compact.

5. Open the locking screw for right/left positioning (7) two revolutions. Move the forearm support to the lower recess in the slot and turn it 180° in this position. Then move the forearm support back to the middle position (setting 0) and tighten locking screw (7) again (see conversion diagram 2 c).

2. Release the wheel brakes (22) and roll the ARTROMOT®-E2 compact to the side of the elbow to be treated. 3. Pull the pin for the swiveling movement of the upper arm support (5) downward and swing the support 180° towards the inside.

Conversion diagram ARTROMOT®-E2 compact:

a

b

c

Conversion diagram ARTROMOT®-E2:

2

1

1

2 84

3 85

English

4. hold the double joint (3) of the motion element and open the locking screw for height adjustment (4) on this side as well.

6.4 Conversion