ARTROMOT-K1 Operating Instructions March 2012

Contents Device description ARTROMOT®-K1

III

Symbol overview ARTROMOT®-K1

V

Figures ARTROMOT®-K1

VIII

1. How to use the CPM device

37

1.1 Fields of application

37

1.2 Therapy objectives

37

1.3 Indications

37

1.4 Contraindications

37

2. ARTROMOT®-K1 description

38

2.1 Description of the device components

38

2.2 Description of the programming unit

39

2.3 Explanation of symbols

41

2.4 Explanation of symbols (connections and nameplate)

42

3. Safety information

44

4. Adjusting the device

48

4.1 Connecting the device, performance check

48

4.2 Connecting the external muscle stimulator ¹

49

4.3 Adjusting the device to the femur length

49

4.4 Adapting the leg support assemblies/footplate

50

5. Setting the treatment values

51

5.1 General information on programming ARTROMOT®-K1

51

5.2 Programming ARTROMOT®-K1 standard models

52

5.3 Treatment value details – standard models

53

5.4 Programming ARTROMOT®-K1 Comfort models

55

5.5 Protocol details – Comfort models

56

6. Care, Maintenance

60

6.1 Care

60

6.2 Maintenance (fuse replacement)

60

6.3. Transport

61

7. Environmental protection statement

62

8. Specifications

62

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

64

9.1 Electromagnetic emissions

64

9.2 Electromagnetic immunity

65

9.3 Recommended separation distances

67

10. How to reach us

68

11. Technical Service

69

11.1 Technical Hotline

69

11.2 Shipment

69

11.3 Spare parts

69

12. Declaration of conformity

70

36

ORMBS-12006_Artromot_K1_Comfort_2012_rz.indb 36

18.05.12 17:27

1.1 Fields of application

1.3 Indications

ARTROMOT®-K1 is a motor-operated Continuous Passive Motion (CPM) device used to mobilize knee and hip joints.

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

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

− joint distortion and contusion

English

1. How to use the CPM device

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

1.2 Therapy objectives

− mobilization of joints in anesthetized patients

CPM therapy with ARTROMOT®-K1 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 and osteotomy − cruciate ligament replacement or reconstruction − endoprosthetic implant

Other objectives of therapy include:

1.4 Contraindications

− improvement of joint metabolism − prevention of joint stiffness − promotion of the regeneration and healing of cartilage and damaged ligaments

Do NOT use ARTROMOT®-K1 on patients with:

− faster hematoma/fluid resorption

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

− improved lymph and blood circulation

− spastic paralysis

− thrombosis and embolism prophylaxis

− unstable osteosynthesis

37

ORMBS-12006_Artromot_K1_Comfort_2012_rz.indb 37

18.05.12 17:27

2. ARTROMOT®-K1 description The motorized CPM device permits extension and flexion of the knee joint in the range of -10°/0°/120°, and of the hip joint in the range of 0°/7°/115°.

11. Footplate 12. Footplate angle fixation screw 13. Clamping lever to adjust footplate rotation and level and to remove the footplate

These are some of the outstanding ARTROMOT®-K1 features:

14. Connection for ARTROSTIM®FOCUS®plus control cable²

− anatomically correct setup − physiological movements

15. Connection for programming unit

− programming unit for precise adjustment of patient-specific therapy parameters

16. Connection for power cord 17. Fuse cap

− symbols for easy operation of the programming unit

18. Power switch (ON/OFF) 19. Nameplate

− programmed therapy parameters saved to chip card

20. Programming unit 21. Patient chip card¹ 22. Compartment for storage of programming unit

Biocompatibility The parts of the ARTROMOT®-K1 device that come in contact with the patient during the intended use, are designed to fulfill the biocompatibility requirements of the applicable standards.

¹ ARTROMOT®-K1 devices with patient chip card only. ² ARTROMOT®-K1 Comfort devices only.

2.1 Description of the device components Note: Please fold out page III! 1.

Thigh support assembly

2. Clamping lever to adjust the height of the thigh support assembly 3. Thigh length scale (femur length scale) 4. Thigh length fixation screws (femur length) 5. Knee hinge 6. Calf support assembly 7. Clamping lever to adjust the height of the calf support assembly 8. Calf length fixation screws (tibia length) 9. Calf length scale (tibia length scale) 10. Strap to secure the foot to the footplate 38

ORMBS-12006_Artromot_K1_Comfort_2012_rz.indb 38

18.05.12 17:27

2.2 Description of the programming unit

patient chip card¹

selected angle of the CPM device selected therapy protocol

English

2.2.1 Programming  unit in normal mode

therapy timer

set extension value

set flexion value

selected direction of motion

parameter keys MENU key

“+” (plus) key

START key

“-” (minus) key

STOP key

¹ ARTROMOT®-K1 devices with patient chip card only. 39

ORMBS-12006_Artromot_K1_Comfort_2012_rz.indb 39

18.05.12 17:27

2.2.2 Programming unit in MENU selection mode

selected MENU level set angle of the CPM device

set extension value

set flexion value

parameters available for selection, corres­ponding selection keys

2.2.3 Programming unit in programming mode

set value of selected function (here: flexion angle)

selected function

selected parameter (here: flexion)

40

ORMBS-12006_Artromot_K1_Comfort_2012_rz.indb 40

18.05.12 17:27

2.3 Explanation of symbols

Also refer to symbol overview on page V / VI ! Standard protocols: extension (stretching the knee)

stretch extension

flexion (bending the knee)

stretch flexion

speed

English

Comfort protocols:

workout protocol

warm up protocol

Comfort protocol

extension pause

EROM repeat extension

flexion pause

EROM repeat flexion

therapy timer EMS control reverse on load (feature for patient safety) therapy documentation transport setting

new patient

total therapy time

service menu

41

ORMBS-12006_Artromot_K1_Comfort_2012_rz.indb 41

18.05.12 17:27

2.4 Explanation of symbols (connections and nameplate)

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. type B applied part

power switch OFF

power switch ON

The number next to this factory symbol is the year of manufacture

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

m

Caution! Observe warnings set forth in operation manual!

Observe Operation Manual

Do not dispose with unsorted municipal waste

Protect from moisture

42

ORMBS-12006_Artromot_K1_Comfort_2012_rz.indb 42

18.05.12 17:27

IP21

The IP rating indicates the level of protection and thus the suitability of the device for use under different ambient conditions. 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 finger – Protection against foreign object: protected against solid foreign object (diameter of 12.5 mm and greater)

Warning! Depending on the device settings, the moving parts of the device present pinch points! Pay particular attention to small children and babies!

English

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

43

ORMBS-12006_Artromot_K1_Comfort_2012_rz.indb 43

18.05.12 17:27

3. Safety information Introduction and definitions

Safety information

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

m Danger! Explosion hazard –

Indicates an imminent hazard. If not avoided, this hazard will result in death or serious injury.

ARTROMOT®-K1 is not designed for use in areas where an explosion hazard may occur. An explosion hazard may result from the use of flammable anesthetics, skin cleansing agents and disinfectants.

m Warning!

m Warning!

Indicates a hazard. If not avoided, this hazard can result in death or serious injury.

Patient hazard –

m Danger!

− Only authorized individuals are allowed to operate the ARTROMOT®-K1 device. 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, this hazard can result in minor personal 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, first without and then with the patient. Check that all fixation screws are tightened. − Stop therapy immediately, when you have doubts about the device settings and/or the therapy protocol.

44

ORMBS-12006_Artromot_K1_Comfort_2012_rz.indb 44

18.05.12 17:27

m Warning! Patient hazard – − It is important that the patient’s position is anatomically correct. Therefore, carefully verify the following settings/positions:

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

1. femur length 2. knee joint axis 3. tibia length and leg rotation 4. leg support assemblies − Movements must not cause pain or irritation.

m Warning!

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

− Extreme caution should be taken when in use around small children and babies! Sufficient distance to the device is mandatory for their safety!

− Only the responsible physician or therapist is able and allowed to choose the therapy parameters and protocols to use. It is the physician’s or therapist’s decision whether or not to use the CPM device on a specific patient.

English

− Stability of the physiotherapy unit must always be ensured while it is in use. The ARTROMOT-K1 must only be set up on surfaces that guarantee its stability. Very soft or instable surfaces (such as waterbeds) are NOT suitable.

− Never leave the device unattended when it is switched on! Switch the device off and disconnect the power line from the wall outlet! − After use, store the device in a safe place! Ensure device stability also during storage!

− The patient must be familiar with the functions of the ARTROMOT®-K1 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.

¹ ARTROMOT®-K1 devices with patient chip card only.

− After data storage, write the patient’s name on the patient chip card. The card should only be used for this patient. If the patient chip card is used for another patient, be sure to delete the previous patient’s data from the card first (see: section 5.2 Programming: “New Patient”). Use original chip cards only.¹ − Any accessories used with ARTROMOT®-K1 must first be approved by DJO Global. − Modifications to the medical device described in this document without the manufacturer’s written consent is prohibited. − The simultaneous treatment of both legs by simultaneous use of two CPM devices is not permitted because the motion elements might interfere with each other. 45

ORMBS-12006_Artromot_K1_Comfort_2012_rz.indb 45

18.05.12 17:27

m Warning!

m Warning!

Equipment malfunction –

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

− 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.

− Allow ARTROMOT®-K1 to reach room temperature before use. If the device has been transported at temperatures below 0 °C/ 30°F), leave it to dry at room temperature for about 2 hours, until any condensation has disappeared. − The ARTROMOT®-K1 device must only be operated in dry rooms.

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

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

− Route all cables below the device frame to either side, ensuring that they cannot get caught by the moving parts during operation. − Inspect ARTROMOT®-K1 for da­mage and loose connections at least once a year. Damaged and worn parts must immediately be replaced with original spare parts by authorized staff.

− Do not use multiple portable socket outlets (MPSO) to connect the device to the power line. ARTROMOT®-K1 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 by the moving parts of the device.

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

− 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®-K1 must be immediately checked by a service technician, before it can be reused.

46

ORMBS-12006_Artromot_K1_Comfort_2012_rz.indb 46

18.05.12 17:27

m Caution! Equipment damage – − Check that the voltage and frequency ratings of your local power line are those indicated on the nameplate. − The leg support element withstands a maximum continuous load of 20 kg, S# <20,000 / 25 kg, S# >20,000.

English

− 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®-K1 device 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.

47

ORMBS-12006_Artromot_K1_Comfort_2012_rz.indb 47

18.05.12 17:27

4. Adjusting the device Note: For a better understanding of each step, please fold out pages III and VIII.

Press the MENU key on the pro­gramming unit until you reach program level 3 (standard model) or program level 5 (Comfort model). Press the “New Patient” parameter key.

4.1 Connecting the device, performance check

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

The equipment supplied includes these items: base unit, programming unit (20), patient chip card (21 - ARTROMOT-K1 versions with chip card only), power cord (not shown), operating instructions

Adjustment with programmed chip card Insert the original patient chip card (21) into the programming unit (20). Press the START key. The CPM device automatically enters the home position.

1. Connect the programming unit (20) to the provided socket (15) by plugging it in and closing the bayonet lock. (With patient chip card versions, insert the chip card into the slot in the programming unit)

Performance check If the programming unit can be operated as described above and ARTROMOT®-K1 enters the home position (for home position values, refer to sections 5.3 and 5.5), the device has passed the performance check.

2. Connect the power cord to socket (16) of the device and mains plug to a wall outlet with a non-fused earthed wire (100 to 240 Volt, 50/60 Hz). 3. Turn the power switch (18) on.

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

4. Follow these steps to set the carriage to the home position.

− An audio signal sounds.

ARTROMOT®-K1 without patient chip card

− The device switches off immediately. − The message “ERR”, accompanied by a code number (e.g. ERR 5), appears on the display.

Press the MENU key on the pro­gram­ming unit until you reach program level 3 (standard model) or program level 5 (Comfort model).

In this situation, you may attempt to restart the unit by turning it briefly off and on again with the power switch. With the unit switched off, 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. . Press the START key. The CPM device automatically enters the home position.

ARTROMOT®-K1 with patient chip card Initial adjustment for new patients Insert the original patient chip card (21) into the programming unit (20). 48

ORMBS-12006_Artromot_K1_Comfort_2012_rz.indb 48

18.05.12 17:27

4.2 Connecting the external muscle stimulator ¹

4.3 Adjusting the device to the femur length

m Caution!

1. Measure the length of the patient’s thigh (femur) from the greater trochanter to the lateral knee joint cavity (Fig. A).

Patient hazard, equipment malfunction – Only the ARTROSTIM®-FOCUS®­ plus muscle stimulator with EN 60601-1 approval, manufactured by DJO Global, may be connected to the ARTROMOT®-K1 device.

3. Set the measured value at the femur scale (3) of the carriage. − Loosen the two fixation screws (4).

Use the “muscle stimulation” cable (part no. 2.0037.024) to connect the muscle stimulator. Other cables are not approved. The cable can be ordered separately from DJO Global.

English

2. Set the carriage to the home position (see 4.1).

− Extend the scale (3) to the required length. − Tighten the fixation screws (4) to set the scale to the new length.

1. Connect the jack plug to the ARTROSTIM®-FOCUS®­plus muscle stimulator.

m Caution! Equipment damage – Do not attempt to extend the femur scale beyond the stop.

¹ For control of an external muscle stimulator an ARTROMOT®-K1 Comfort device and the corresponding connector are required.

2. Connect the round plug to connector (14) of the ARTROMOT®-K1 and turn it a short way clockwise to lock. 3. Turn on ARTROMOT®-K1 and then the muscle stimulator.

Note! For information on connecting and programming the muscle stimulator, refer to the operation manual that comes with the ARTROSTIM®-FOCUS®plus.

49

ORMBS-12006_Artromot_K1_Comfort_2012_rz.indb 49

18.05.12 17:27

4.4 Adapting  the leg support assemblies/footplate

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

1. Set the leg support assemblies and the footplate (1, 6, 11) to the expected positions before accommodating the patient. − Loosen fixation screws (8) to adjust the footplate (11) to the length of the patient’s lower leg (Fig. C).

Symbol 1: Measurement of the patient’s femur length from the grea­ter trochanter to the knee joint cavity.

Loosen clamping lever (13) and adapt the footplate’s rotation and height to the patient (Fig. D). Loosen fixation screw (12) and adapt the angle to the patient’s foot (turn the screw a few revolutions until the footplate can be easily adjusted).

Symbol 2: Set the carriage to the home position (see 4.1) and adjust it to the measured femur length.

For short patients you can reverse the footplate’s bracket 180° (Fig. H) to adapt the footplate to shorter calves: • Loosen clamping lever (13) and remove the footplate (11).

Symbol 3: Adjust height of calf and thigh support assemblies. Adjust the footplate to the height and length of the lower leg.

• Loosen the fixation screws (12). • Reverse the bracket 180°. • Screw the footplate to the bracket and tighten the clamping lever.

Note!  hen reversing the footplate, ensure W that the pins below the clamping lever engage with the recesses in the bracket.

− To adjust the height of the support assemblies for calf (1) and thigh (6), loosen clamping levers (2) and (7) (Figs. E/F). 2. Place the patient’s leg on the carriage and repeat the steps outlined under 1 above to adjust the device to the patient.

m Caution! Equipment damage – Cover the leg support assemblies with disposable tissues when using ARTROMOT®-K1 immediately after surgery. This helps prevent discoloration.

50

ORMBS-12006_Artromot_K1_Comfort_2012_rz.indb 50

18.05.12 17:27

5. Setting the treatment values

m Warning! 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.

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

English

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.

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

Note!

6. Then press the START key to start therapy.

See also 2.2 and 2.3 as well as page VIII !

Note!

5.1 General information on programming ARTROMOT®-K1

− Refer to sections 5.3 and 5.5 for a description of the parameters. − To view the set parameter values, press the corresponding parameter key. However, this is only possible when you press the STOP key first.

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

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

2. The various treatment parameters and functions are allocated to three (standard model) or five (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.

Press both keys again for approx. 3 seconds to unlock.

− 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.

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.

− Emergency stop function: ARTROMOT®-K1 will stop immediately, when any of the keys is pressed during therapy. Patient treatment can be resumed by pressing the START key. The device will automatically change the direction.

This is what happens when you press one of the parameter keys to select a parameter: − The corresponding symbol appears on the display in a larger format. − The set value is displayed. − The symbol above the parameter key appears in reverse video. 51

ORMBS-12006_Artromot_K1_Comfort_2012_rz.indb 51

18.05.12 17:27

LEVEL 3:

Patients with a programmed chip card

− transport setting − new patient

− Insert the chip card (the patient is not yet positioned on the CPM device).

− total therapy time

− Perform the mechanical adjustments of the CPM device (femur length, etc.).

− Service menu

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

Note!

5.2 P  rogramming ARTROMOT®-K1 standard models

− While you adjust the extension/ flexion values, the CPM device 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®-K1 Standard models.

− Special functions can be programmed and retrieved with ARTROMOT®-K1 Comfort devices (see sections 5.4 and 5.5).

You change between levels by pressing the MENU key.

− Only ARTROMOT®-K1 chip card models allow therapy protocols to be saved to an inserted chip card.

The display always indicates on which level you are. The following treatment values, settings and information can be entered/viewed on the programming unit (20):

LEVEL 1: − e xtension (stretching the knee) − flexion (bending the knee) − speed − warm up protocol

LEVEL 2:

MENU

− extension pause − flexion pause − therapy timer − reverse on load (feature for patient safety)

MENU

52

ORMBS-12006_Artromot_K1_Comfort_2012_rz.indb 52

18.05.12 17:27

values set for stretching and bending. The range of motion increases with each cycle, until the programmed maximum values are reached after a total of 15 cycles. default setting: disabled

5.3 Treatment value details – standard models You access the different programming levels by repeated depressions of the MENU key.

n extension pause

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

Pauses occur at the extension limit, just before the bending movement starts. Pauses can be set to any value between 0 and 59 seconds in steps of 1 second, and to values between 1 and 59 minutes in steps of 1 minute. default setting: no pause

− You save the settings by pressing the STOP key.

LEVEL 1:

English

LEVEL 2:

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

n flexion pause Pauses occur at the flexion limit, just before the stretching movement starts. Pauses can be set to any value between 0 and 59 seconds in steps of 1 second, and to values between 1 and 59 minutes in steps of 1 minute. default setting: no pause

n extension (stretching) − maximum knee extension: -10 degrees − maximum hip extension: 7 degrees n flexion (bending)

n therapy timer

− maximum knee flexion: 120 degrees

Default setting is continuous operation of the carriage. A clock symbol in the upper right-hand corner of the display identifies the continuous mode of operation. The clock indicates the elapsed therapy time. In the continuous mode, the device must be stopped with the STOP key.

− maximum hip flexion: 115 degrees

Note! The programmed value and the value measured at the patient’s knee may deviate slightly.

However, you can also select therapy durations of 1 to 59 minutes in steps of 1 minute and of 1 to 24 hours in steps of 30 minutes. When the time has elapsed, the device switches automatically off and stops in the position: extension + 10°. In this case, a circle replaces the clock symbol. The circle fills as the therapy time progresses.

n speed The speed can be adjusted between 5 % and 100 % in steps of 5 %. default setting: 50 % n warm up protocol During warm up, the patient will slowly become used to the set maximum extension and flexion values, starting from the middle position. The warm up protocol starts in the middle between the two maximum 53

ORMBS-12006_Artromot_K1_Comfort_2012_rz.indb 53

18.05.12 17:27

The “New Patient” function (home position) selects the following settings:

n r everse on load feature for patient safety The device automatically starts moving in the opposite direction of the last movement when the patient’s resistance (load) exceeds the set value. Adjustable levels for reverse on load feature: 1 – 25. At level 1, very low resistance will cause the device to reverse; at level 25, a high resistance is required to initiate the reversal. default setting: level 25

m Caution! Patient hazard –

− extension:

25°

− flexion:

35°

− speed:

50%

− warm up:

disabled

− extension pause:

0

− lexion pause:

0

− timer:

continuous operation

− reverse on load:

25

− total therapy time:

0

n total therapy time

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.

ARTROMOT®-K1 models without patient chip card The total therapy time is the added sum of operating hours. If the device is used by only one patient, this time is equivalent to the duration of all the patient’s therapy sessions. Under menu item “total therapy time” of ARTROMOT®-K1 models with chip card you can view each patient’s total therapy time (duration of all the patient’s therapy sessions).

LEVEL 3: n transport setting With this function, the carriage will move to a position optimally suited for packing the CPM device. Set the femur length on 49 cm and the lower leg on 45 cm. Select the function and press the START key. The carriage moves to the transport position. (see 6.3)

Deleting the stored therapy time Press and hold the parameter key for 5 seconds or select the New Patient function. n Service MENU For service purposes only, refer to Service Manual.

n new patient

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

With this function, the CPM device will move to the home position, allowing the mechanical settings to be completed. Select the function and press the START key. The device enters the home position and existing therapy parameters will be deleted. With ARTROMOT®-K1 devices with patient chip card, the factory defaults will be restored. All values stored on the chip card will be deleted. The carriage will stop in the home position.

54

ORMBS-12006_Artromot_K1_Comfort_2012_rz.indb 54

18.05.12 17:27