A-MOT K4 GA engl DV2 801 23.01.2008 12:21 Uhr Seite 1 ... K4... · 2.2 Description of the programming unit 7 ... − Do not use multiple portable socket outlets ... quency ratings

Operation ManualStarting with serial number higher than 10 000

ARTROMOT®-K4

A-MOT K4 GA engl DV2 801 23.01.2008 12:21 Uhr Seite 1

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SchnittmarkeA-MOT K4 GA engl DV2 801 23.01.2008 12:21 Uhr Seite 2

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Device description

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21 20 19 18 17 16 15 14 13 12 11


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Device description 3

Symbol overview ARTROMOT®-K4 29

Illustrations for device setup 34

1. How to use the CPM device 51.1 Fields of application 51.2 Therapy objectives 51.3 Indications 51.4 Contraindications 5

2. Description of the ARTROMOT®-K4 62.1 Description of the device components 62.2 Description of the programming unit 72.3 Explanation of symbols 92.4 Explanation of symbols (connections and nameplate) 10

3. Safety information 11

4. Device setup 144.1 Connecting the device, performance check 144.2 Mechanical Settings 144.3 Adjusting the Patient Kit 15

5. Setting the treatment values 165.1 General information on programming ARTROMOT®-K4 165.2 Programming ARTROMOT®-K4 175.3 Therapy parameter details 17

6. Care, Maintenance 206.1 Care 206.2 Maintenance (fuse replacement) 206.3 Conversion 21

7. Environmental Protection Statement 22

8. Specifications 22

9. IEC 60601-1-2:2001 239.1 Electromagnetic emissions 239.2 Electromagnetic immunity 249.3 Recommended separation distances 26

10. Contact 26

11. Technical service 2711.1 Technical Hotline 2711.2 Shipment 2711.3 Spare Parts 27

Declaration of Conformitiy 28

Contents


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ARTROMOT®-K4 is a motor-operatedContinuous Passive Motion (CPM)device providing motion to the shoulderjoint.

Suitable for use in hospitals, clinics,general practices and rental services, itis an important supplement to medicaland therapeutic treatment.

CPM therapy with ARTROMOT®-K4 ismainly used to prevent the negativeeffects of immobilization, to allowpatients to regain painless mobility ofjoints at an early stage and to promotehealing and achieve a positive functio-nal result.

Other objectives of therapy include:

- improvement of joint metabolism

- prevention of joint stiffness

- promotion of the regeneration andhealing of cartilage areas and dam-aged ligaments

- faster hematoma/fluid resorption

- improved lymph and blood circulation

- thrombosis and embolism prophylaxis

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

- joint distortion and contusion

- arthrotomy and arthroscopy proce-dures in combination with synovec-tomy, arthrolysis or other intra-articu-lar interventions

- mobilization of joints in anesthetizedpatients

- operative treatment of fractures,pseudoarthrosis and correctiveosteotomy

- cruciate ligament replacement orreconstruction

- endoprosthetic implants

Do NOT use ARTROMOT®-K4 onpatients with:

- acute inflammatory processes in thejoints, unless on the order of a physi-cian

- spastic paralysis

- unstable osteosynthesis

1.4 Contraindications

1.3 Indications

1.2 Therapy objectives

1.1 Fields of application

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1. How to use the CPM device


The motorized CPM device permitsextension and flexion of the knee jointin the range of -10 ° - 0 ° - 125 °,

and of the hip joint in the range of0 ° - 10 ° - 100 °.

It can be used on either side, butrequires a configuration change.

These are some of theARTROMOT®-K4 features:

- programming unit for precise adjust-ment of patient-specific therapyvalues

- symbols for easy operation of theprogramming unit

- physiological movements

- anatomically correct setup

Biocompatibility

Those parts of the ARTROMOT®-K4device that come into contact with thepatient when the device is used asintended, are designed to fulfil thebiocompatibility requirements of theapplicable standards.

Note:Please fold out page 3!

1. Compartment for storage ofprogramming unit

2. Footplate with patient kit

3. Knobs for ankle adjustment offoot inclination

4. Knobs for length adjustment oflower leg

5. Lower leg patient kit

6. Knee pivot point

7. Thigh patient kit

8. Thigh support

9. Knob for femur length adjustment

10. Hip axis pivot point

11. Locking pin for high adjustment ofhip pivot point

12. Spare tube

13. Release tubes for square tube

14. Coiled cord

15. Hand-held programming unit

16. Power switch (ON/OFF)

17. Fuse cap

18. Connection for power cord

19. Connection for programming unit

20. Base

21. Knob for rotation of footplate

2.1 Description of thedevice components

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2. Description of the ARTROMOT®-K4


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2.2 Description of the programming unit

2.2.1 Programming unit in normal mode

currentcarriage angle

therapy timer

set flexion value

parameter keys

MENU key

START key

STOP key

selected therapyprotocol

set extensionvalue

current directionof motion

+ (plus) key

- (minus) key


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2.2.2 Programming unit in MENU selection mode

2.2.3 Programming unit in programming mode

selected MENU levelset carriage angle forinternal / externalrotation

parameters availablefor selection, corres-ponding selectionkeys

set extension value set flexion value

selected function

selected parameter(here: flexion)

status of the selectedfunction (here: flexionangle)


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Also refer to symbol overview on page 29.

extension (stretchingthe knee)

flexion (bending theknee)

speed

warm-up protocol

extension pause

flexion pause

therapy timer

reverse on load featurefor patient safety

transport setting

new patient

total therapy time

service menu

2.3 Explanation of symbols


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2.4 Explanation of symbols (connections and nameplate)

Alternating current

Protective earthconnection

Type B applied part

Power switch OFF

Power switch ON

Refer to accompanyingdocuments

Do not dispose of productwith unsorted householdor municipal waste.


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Definitions

Read the safety statements before useof the CPM device. The safety state-ments are classified as follows:

Safety information

� Warning!Patient hazard —

– Only authorized individuals areallowed to operate theARTROMOT®-K4 device. Individualsare authorized after receivingtraining in the operation of thedevice and reading this operationmanual.

− Before using the device, the opera-tor must ascertain that it is incorrect working order and operatingcondition. In particular, the cablesand connectors must be checkedfor signs of damage. Damagedparts must be replaced immediately,before use.

− Before therapy, a test run consis-ting of several exercise cycles mustbe completed, first without and thenwith the patient. Check that allsetting screws are tightened.

− Stop therapy immediately, whenyou have doubts about the devicesettings and/or the therapyprotocol.

− It is important that the patient'sposition is anatomically correct.Check the following settings/posi-tions:

1. femur length

2. knee joint axis

3. lower leg length and rotationalposition of the leg

4. patient kits

− Movements must not cause anypain or irritation.

− Patients must be fully consciouswhile being instructed in the use ofthe CPM device and during therapy.

� Danger!Explosion hazard —

ARTROMOT®-K4 is not designed foruse in areas where an explosionhazard may occur. An explosionhazard may result from the use offlammable anesthetics, skin cleansingagents and disinfectants.

� Caution!indicates a potential hazard. If notavoided, this hazard can result inminor personal injury and/or pro-duct/property damage.

� Warning!This term indicates a hazard. If notavoided, this hazard can result indeath or serious injury.

� Danger!This term indicates an imminenthazard. If not avoided, this hazard willresult in death or serious injury.

3. Safety information


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− The choice of the therapy parame-ters to program and of the therapyprotocols to use is restricted tothe responsible physician ortherapist. It is the physician's ortherapist's decision whether or notto use the CPM device on a specificpatient.

− The patient must be familiar with thefunctions of the ARTROMOT®-K4programming unit and the unit mustbe within easy reach of the patient,allowing him or her to stop therapy,if needed. Patients unable tooperate the programming unit,e.g. paralytic patients, must neverbe left unattended during therapy.

− All accessories used with theARTROMOT®-K4 device must firstbe approved by ORMED.

− Do not allow parts of the body orany objects (such as blankets,cushions or cables) to get caught inthe moving parts of the CPMdevice.

� Warning!Shock hazard —

Strictly observe the following war-nings. Failure to do so endangers thelives of the patient, the user and otherpersons involved.

− Before use allow theARTROMOT®-K4 to reach roomtemperature. If the device has beentransported at temperatures below0 °C (32°F), leave it to dry at roomtemperature for about 2 hours, untilany condensation has disappeared.

− The ARTROMOT®-K4 device mustonly be operated in dry rooms.

− When disconnecting the devicefrom the power line, remove theplug from the wall outlet first, beforedisconnecting the cable from thedevice.

− When connecting the device toother equipment or when creating amedical system, check that the sumof leakage currents will not causeany hazard. Please contact ORMED,if you have questions in this matter.

− Do not use multiple portable socketoutlets (MPSO) to connect thedevice to the power line.ARTROMOT®-K4 must be connec-ted to a properly installed walloutlet with a non-fused earthedwire. Before connecting the powercord, it must be completely unrolledand placed such that it will not getcaught in the moving parts of thedevice.

− Before cleaning and service inter-ventions, disconnect the devicefrom the power line by removingthe power cord from the wall outlet.

− Liquids must not be allowed toenter the CPM device or the pro-gramming unit. If liquids haveentered into the devices,ARTROMOT®-K4 must be immedia-tely checked by a service techni-cian, before it can be reused.


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� Caution!Preventing chafing and pressure sores If your patient is adipose, very tallor very short, be sure to preventchafing and pressure sores. Place theleg concerned in a moderate abduc-tive position, if deemed appropriate.

� Warning!Equipment malfunction

– Magnetic and electrical fields arecapable of interfering with theproper performance of the device.For this reason make sure that allexternal devices operated in thevicinity of the CPM device complywith the relevant EMC requirements.X-ray equipment, MRI devices, radiosystems and cell phones are possi-ble sources of interference as theymay emit higher levels of electroma-gnetic radiation.Keep the CPM device away fromthese devices and verify its perfor-mance before use.

− Refer repair and maintenance toauthorized persons.

− Route all cables below the deviceframe to either side, ensuring thatthey cannot get caught in themoving parts during operation.

− Inspect ARTROMOT®-K4 fordamage and loose connections atleast once a year. Damaged andworn parts must immediately bereplaced with original spare parts byauthorized staff.

� Caution!Equipment damage

– Check that the voltage and fre-quency ratings of your local powerline are those indicated on thenameplate.

− The leg support element withstandsa maximum continuous load of30 kg (66.13 lb).

− Do not allow any objects (such asblankets, cushions, or cables) to getcaught in the moving parts of theCPM device.

− Do not expose the ARTROMOT®-K4device to direct sunlight, becausesome of the components may reachinadmissibly high temperatures.


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Note: For a better understanding ofeach step, please fold out pages 3and 34.

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

2. Connect the programming unit (15) tosocket (19) of the device.

3. Turn the power switch (16) on.

4. Follow these steps to set the carriageto the home position:

• Press the MENU button on theprogramming unit until you reachprogramming level 4.

• Press the New Patient parameterkey twice.

• Press the START key. The CPMdevice automatically enters thehome position.

If the programming unit can be opera-ted as described above andARTROMOT®-K4 enters the homeposition (for home position values, referto section 5.3), the device has passedthe performance check.

The device also runs performancechecks regularly during operation. Thisis what happens, if a problem is identi-fied:

− An audio signal sounds.

− The device switches off immediately.

− The message "ERR" and an errorcode (e.g. ERR 5) appear on thedisplay.

In this situation, you may attempt torestart the device by turning it briefly offand on again with the power switch. Ifthe error message persists, have thedevice inspected by a Service techni-cian, before using it again.

1. Set the carriage to the home position(see 4.1) or to an angle that allowsthe patient to position the leg on thesupport without experiencing anypain.

2. To begin with, set the hip pivot (10) ofthe carriage to the patient's hip pivot.

• To do so, pull on the locking pin(11) of the height adjustment for thecarriage hip pivot (10).

• Then lift the insert for adjusting theheight of the carriage hip pivot tothe level of the patient's greatertrochanter.

• Now re-insert the locking pint (11).

Note!Before you adjust the ARTROMOT®-K4to the patient, you may have toconvert the device for use on the leftor right knee joint.

(see section 6.3 Conversion)


Connect only the original program-ming unit designed for the device inuse. Any attempt to connect anotherprogramming unit to this device maycause damage.

4.2 Mechanical Settings

Performance check

4.1 Connecting the device,performance check

4. Device setup


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3. Adapting the carriage to the femurlength (Fig. 2)

• Press on the locking pin at thefemur length adjustment (9) torelease the lock.

• Adjust the appropriate femur length(8).

• Fix the setting by releasing thelocking pin (9).

4. Adapting the carriage to the tibialength (Fig. 3)

• Loosen the two fixation screws (4).

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

• Tighten the screws (4) to fix thesetting.

5. Adjusting the dorsal extension /plantar flexion position (Fig. 4)

• Loosen the two fixation screws (3).

• Set the foot plate (2) to an anglethat is comfortable for the patient.

• Tighten the screws (3) to fix theangle setting.

6. Adjusting the foot rotation position(Fig. 5)

• Loosen the fixation screw (21).

• Set the foot plate (2) to a rotationposition that is comfortable for thepatient.

• Tighten the screw (21) to fix thesetting.

1. Using the Velcro tapes, attach thepatient kits for lower leg (5) and thigh(7) to the frame of the motion ele-ment. (Fig. 6 and Fig. 7)

2. Now position the patient's leg on thecarriage and adjust the height withthe help of the Velcro tapes and byrepeating the steps at 1.

Ensure that the exercise will only beperformed in a range of motion thatdoes not cause any pain and providesmaximum comfort for the patient,

� Caution!Patient hazard

Ensure that the rotational axes of theCPM device and of the knee jointcoincide both in the vertical and in thehorizontal plane (Fig.8).

4.3 Adjusting the Patient Kit


Please do not try to pull out the femurlength adjustment past the stop.


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Note: See also 2.2 and 2.3 as well aspage 29!

1. You activate the programming modeby briefly pressing the MENU key onthe programming unit.

2. The treatment parameters andfunctions are allocated to four pro-gramming levels (four per level).

To be able to program a parameteryou will have to access the corres-ponding programming level. This isalso done with the MENU key. Witheach key press you advance onelevel. The code M1, M2, etc. thatappears in the middle of the displayindicates the programming level.

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

3. You activate the treatment parame-ters and functions with the fourparameter keys below the display.The symbols above the four para-meter keys indicate the assignedparameters and functions.

This is what happens when you pressone of the parameter keys to select aparameter:

• The corresponding symbol appearson the display in a larger format.

• The set value is displayed.

• The symbol above the parameterkey appears in reverse video.

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

Some of the (special) functions canonly be enabled and disabled. This isdone by pressing the correspondingparameter key or with the + / - keys.Active parameters are identified witha check mark in the circle next to thesymbol.

5. Then press the START key to starttherapy.

If a special function is activated, thecarriage will first move to the middleposition. Press the START key againto start therapy.

Note!• Refer to section 5.3 for a descrip-

tion of the parameters.

• To view the set parameter values,press the corresponding parameterkey. However, this is only possiblewhen you press the STOP key first.

• To prevent accidental changes ofthe parameter settings, lock thekeys by simultaneously pressingthe + (plus) and – (minus) keys.

by simultaneously pressing the +(plus) and – (minus) keys. Press bothkeys again to unlock.

• Emergency stop function:ARTROMOT®-K4 will stop immedia-tely, when any of the keys is pressedduring therapy. Patient treatment canbe resumed by pressing the STARTkey. The device will automaticallychange the direction.

5.1 General informationon programmingARTROMOT®-K4

� Warning!Patient hazard

Before therapy, a test run consistingof several exercise cycles must becompleted without the patient. Thenrepeat the test run with the patientand check that the movement doesnot cause any pain.

5. Setting the treatment values


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To program the different settings of theARTROMOT®-K4, access the respec-tive programming level.

You change between levels by pressingthe MENU key repeatedly.

The display always indicates thecurrently selected level.

The following treatment values,settings and information can beentered/viewed on the programmingunit (15):

LEVEL 1:

- Extension(stretching the knee)

- Speed

- Warm-up protocol

- Flexion(bending the knee)

LEVEL 2:

- Extension pause

- Therapy timer

- Reverse on load(feature for patient safety)

- Flexion pause

LEVEL 3:

- Transport setting

- New patient

- Total therapy time

- Service menu

• You access the different program-ming levels by repeated depressionsof the MENU key.

• You select the treatment parameterswith the corresponding parameterkey.

• You change the treatment values withthe + / - keys and you enable/disablefunctions by pressing the correspon-ding parameter key again.

• You save the settings by pressing theSTOP key.

5.2 ProgrammingARTROMOT®-K4

• If the carriage is positioned withinthe programmed range of motion atthe time therapy begins, the therapysession will start immediately.

• If the carriage is positioned outsidethe programmed range of motion atthe time therapy begins, it will firstmove to the angle setting "extension+10°". It will stop in this positionand you can start the therapysession by pressing the START key.

5.3 Therapy parameterdetails

Note!

It is possibe to modify individualtreatment parameters or all parame-ters together. If individual treatmentparameters are modified, the settingsof all other parameters remainunchanged.

MENU

MENU


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LEVEL 1:

� Extension (stretching)

- Maximum knee extension:-10 degrees

- Maximum hip extension:10 degrees

� Flexion (bending)

- Maximum knee flexion:125 degrees

- Maximum hip flexion:100 degrees

� Speed

The speed can be adjusted between1 % (0.3°/s) and 100 % (3°/s) in stepsof 1 %.Default: 100 %

� Warm-up protocol

During warm up, the patient willslowly become used to the setmaximum extension and flexionvalues, starting from the centerposition.

The warm up protocol starts in themiddle between the two maximumvalues set for stretching and bending.With each cycle, the range of motionis increased, within 15 cycles themaximum value is attained.Default: disabled

LEVEL 2:

� Extension pause

Pauses occur at the extension limit,just before the bending movementstarts. Pauses are adjustable insteps of 1 second between 0 and30 secondsDefault: no pause

� Flexion pause

Pauses occur at the flexion limit,just before the stretching movementstarts. Pauses are adjustable insteps of 1 second between 0 and30 secondsDefault: no pause

� Therapy timer

Default setting is continuousoperation.

A clock symbol in the upper right-hand corner of the display identifiesthe continuous mode of operation.The clock indicates the elapsedtherapy time.In the continuous mode, the devicemust be stopped with the STOP key.

However, the therapy timer can beset in steps of 1 minute to anyvalue between 1 and 300 minutes.When the time has elapsed, thedevice switches automatically off andstops in the position – set extension-value +10°.In this case, a circle replaces theclock symbol. The circle fills as thetherapy time progresses.

� Reverse on load featurefor patient safety

The device automatically startsmoving in the opposite direction ofthe last movement when the patient'sresistance (load) exceeds the setvalue.Adjustable levels for reverse on loadfeature: 1-25minimum setting 1 = 10 kpmaximum setting 25 = 45 kp.

At 1/10 kp, very little resistance willcause the device to reverse; at25/45 kp, a high resistance is requi-red to initiate the reversal.Default: 25/45 kp

Note!• These values are approximate

values.

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

Note!The programmed value and the valuemeasured at the patient's knee maydeviate slightly. The most importantfactor is painless motion of thepatient's knee.


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LEVEL 3:

� Transport setting

With this function, the carriage willmove to a position optimally suitedfor packing the CPM device. Selectthe function and press the STARTkey. The carriage moves to thetransport position.

� New patient

With this function, the CPM devicewill move to the home position,allowing the mechanical settings tobe completed. Select the functionand press the START key. The deviceenters the home position and existingtherapy parameters will be deleted.

The "new patient" function (homeposition) selects the followingsettings:

- extension: 25 °

- flexion: 35 °

- speed: 100 %

- warm up: disabled

- extension pause: 0

- flexion pause: 0

- timer: continuousoperation

- reverse on load: 25/45 kp

- total therapy time: 0

� Total therapy time

The total therapy time is the addedsum of operating hours.

If the device is used by only onepatient, this time is equivalent to theduration of all the patient's therapysessions.

Deleting the stored therapy timePress and hold the parameter key for5 seconds or select the New Patientfunction.

� Service menu

For service purposes only, refer toService Manual.

Reminder:

You save the selected parameter valuesby pressing the STOP key.

� Caution!Patient hazard The reverse on loadfeature is a safety measure to protectthe patient in the event of cramps,spasms, locked joints and similarsituations. The manufacturer cannotbe held liable for misuse of thisfeature.


- ARTROMOT®-K4 can be disinfectedby wiping down with a disinfectant.Thus, it complies with the specialhygiene standards for medicaltechnical equipment.

- The enclosure can be cleaned withcommon disinfectants and mildhousehold cleaning agents.

- Only use a damp cloth to wipe theCPM device down.

Visually inspect the device for signs ofmechanical damage before each use.

If you detect damage or malfunctionsthat may impair the safety of the patientor of the operator, have the devicerepaired before using it.

For safety, the devices require regularmaintenance. To maintain the functionaland operational safety, check all com-ponents for damage and loose connec-tions at least once a year.

These checks should be performed bypersons with adequate training andexperience. Damaged and worn partsmust immediately be replaced withoriginal spare parts by authorized staff.

The device does not require additionalregular maintenance.

� Warning!Patient hazard, equipment malfunc-tion and damage

The replacement of fuses must bereferred to specialists as defined inIEC 60364 or other applicable stan-dards (e.g. biomedical technicians,electricians, electronics installers).

Before replacing fuses, turn off theARTROMOT®-K4 and disconnect thedevice from the power line.

Fuses used must be T1A fuses.

Fuse replacement

Technical inspections

Check before each use

6.2 Maintenance(fuse replacement)


− The plastic material used is notresistant to mineral acids, formicacid, phenols, cresols, oxidants andstrong organic or inorganic acidswith a pH value below 4.

− Use only clear disinfectants toprevent discoloration of the device.

− Do not expose the CPM device tostrong ultraviolet radiation (sunlight)and fire.

− Do not use cleaning agents thatcontain chloride.

� Warning!Shock hazard

Remove the power cord from the walloutlet before cleaning.

Shock hazard, equipment damage

Liquids must not enter the device orthe programming unit.

6.1 Care

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6. Care, Maintenance


Use an appropriate tool to remove thefuse holder situated between the powerswitch and the power connector(Fig. 1). Replace the fuses and reinsertthe fuse holder (Fig. 2). Ensure that thefuse holder properly locks into place.

Fig. 1

Fig. 2

The ARTROMOT®-K4 allows thepatient's knee and hip pivot to beadjusted once.

For this purpose, the carriage may haveto be reconfigured from left to right.

With this reconfiguration feature, theanatomical accuracy of the carriage isoutstanding.

1. To begin with, set the carriage to aknee angle of 80° to 90° (see also:5.1) and stop it there.

2. Pull on the locking pin (11) for theheight adjustment of the carriage hippivot and remove the height adjust-ment from the carriage. (Fig. 9)

3. Hold the height adjustment. Removethe entire femur length adjustment (8)mechanism: To do so, open thebayonet lock by turning it a quarterrevolution and pull the mechanismfrom the holding tube. (Fig. 10)

4. Attach the femur length adjustmentmechanism on the other side. To doso, observe the instructions given at3, reversing the order.

5. Now press the buttons (13) simulta-neously and pull the length adjust-ment for the hip height adjustmentfrom the carriage housing. (Fig. 11)

6. Then insert the length adjustment forthe hip height adjustment into thecarriage housing on the other sideuntil you hear it engage.

7. Pull on the locking pin (11) for theheight adjustment of the carriage hippivot and reinsert the height adjustmentinto the holding tube. When the correctheight is reached, release the lockingpin to fix the set height. (Fig. 12).

Fig. 12

Fig. 11

Fig. 10

Fig. 9

Note!For the correct assembly and lockingof the bayonet lock, please observethe sticker on the ARTROMOT®-K4.

6.3 Conversion

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The product described in this operationmanual must not be disposed of withunsorted household or municipal waste.It requires separate disposal.

Please contact ORMED or your localdealer for information about the possi-ble recycling of the product.

Input ratings: 100 – 240 V AC/ 50 – 60 Hz

Current consumption: 850 - 370 mA

Fuses: 2 x T1A(slow-blow)

Protection class: I

IP degree of protection: IPX0

Applied part: type B

Max. load on carriage: 30 kg (66.13 lb)

Physical:

Length: 115 cm(45.28 In)

Width: 39.5 cm(15.55 In)

Height: 55 cm(21.65 In)

Adjustment ranges (min./max.):

femur range: approx. 32-50 cm(12.59-19.69 in)

lower leg range: approx.39.5 – 56 cm(15.55-22.04 in)

Weight: 13 kg (28.66 lb)

Materials used:

ABS, POM (Delrin 100), PUR, PA, FR4,aluminum, stainless steel, brassSteel: 1.4301; 1.4305; 1.4310

MDD: class 2a

Standards IEC 60601-compliance: 1:1988

+ A1:1991+ A2: 1995

Certification: ANSI / UL60601-1

CAN / CSAC22.2 No. 601.1

EMC IEC 60601-1-(electromagnetic 2:2001compatibility)

Ambient conditions(storage, transport)

Ambient temperature: -24 ºC to +60 ºC(50 to +104 °F)

Relative humidity: 20 % to 85 %

Atmospheric pressure: 700 hPa to1060 hPa

Ambient conditions (operation)

Ambient temperature: +10 ºC to +40ºC (50 to +104 °F)

Relative humidity: 30% to 75%

Atmospheric pressure: 700 hPa to1060 hPa

_________________________________

Subject to change without notice(10/07)

8. Specifications

7. EnvironmentalProtection Statement

22


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The ARTROMOT®-K4 device is subjectto particular precautions regardingelectromagnetic compatibility (EMC).The device must be installed and putinto service strictly in compliance withthe EMC directives put forth in theaccompanying documents.

Portable and mobile RF communicationsystems may affect the ARTROMOT®-K4device.

The ARTROMOT®-K4 device should notbe used adjacent to or stacked withother equipment. If adjacent or stackeduse is necessary, ARTROMOT®-K4should be observed to verify normaloperation in the configuration in which itwill be used.

If you detect damage or malfunctionsthat may impair the safety of the patientor of the operator, have the devicerepaired before using it.

If it is necessary to replace assembliesor cables only the manufacturer'soriginal parts may be used to ensurecontinued compliance with EMCrequirements after repair. This require-ment applies to the power supply unit,cables and cable lengths, drive unitconsisting of the motor and the controlsystem, the programming unit incl. thecoiled cable and the connector.

9. IEC 60601-1-2:2001

9.1 Electromagnetic emissionsGuidance and Manufacturer’s Declaration – Electromagnetic Emissions

ARTROMOT®-K4 is intended for use in the electromagnetic environment specified below. It is theresponsibility of the customer or user to ensure that the ARTROMOT®-K4 device is used in suchan environment.

Emissions test Compliance Electromagnetic environment - guidance

RF emissions to CISPR 11 Group 1 ARTROMOT®-K4 uses RF energy only for itsinternal function. Therefore, its RF emissionsare very low and are not likely to cause anyinterference in nearby electronic equipment.

RF emissions to CISPR 11 Class B ARTROMOT®-K4 is suitable for use in allestablishments, including domestic and thosedirectly connected to the public low-voltagepower supply network that supplies buildingsused for domestic purposes.

Harmonic emissions to IEC61000-3-2

not applicable

Voltage fluctuations/flickeremissions toIEC 61000-3-3

not applicable


NOTE: UT is the a.c. mains voltage prior to application of the test level.

9.2 Electromagnetic immunityGuidance and Manufacturer’s Declaration – Electromagnetic Immunity

ARTROMOT®-K4 is intended for use in the electromagnetic environment specified below. It isthe responsibility of the customer or user to ensure that the ARTROMOT®-K4 device is used insuch an environment.

Immunity test IEC 60601 testlevel

Compliancelevel

Electromagneticenvironment – guidance

Electrostaticdischarge (ESD)toIEC 61000-4-2

± 6 kV contact

± 8 kV air

± 6 kV contact

± 8 kV air

Floors should be wood, concrete orceramic tile. If floors are coveredwith synthetic material, the relativehumidity should be at least 30%.

Electrical fasttransient/bursttoIEC 61000-4-5

± 2 kV for powersupply lines

± 1 kV forinput/output lines

± 2 kV for powersupply lines

± 1 kV forinput/output lines

Mains power should be that of atypical commercial or hospitalenvironment.

Surges toIEC 61000-4-5

± 1 kV differentialmode

± 2 kV commonmode

± 1 kV differentialmode

± 2 kV commonmode

Mains power should be that of atypical commercial or hospitalenvironment.

Voltage dips,short interrup-tions andvoltage varia-tions on powersupply inputlines to IEC61000-4-11

< 5% UT(> 95% dip in UT)for 1⁄2 cycle

40% UT(60% dip in UT) for5 cycles


< 5% UT(> 95% dip in UT)for 5 s

< 5% UT(> 95% dip in UT)for 1⁄2 cycle



< 5% UT(> 95% dip in UT)for 5 s

Mains power should be that of atypical commercial or hospitalenvironment. If the user of theARTROMOT®-K device requirescontinued operation during powermains interruptions, it is recom-mended that the ARTROMOT®-K4device be powered from an uninter-ruptible power supply or a battery.

Power frequency(50/60 Hz)magnetic field toIEC 61000-4-8

3 A/m 3 A/m Power frequency magnetic fieldsshould be at levels characteristic ofa typical location in a typicalcommercial or hospital environment.

24


25

NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.

NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affectedby absorption and reflection from structures, objects, and people.

a) Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)telephones and land mobile radio, AM and FM radio broadcast and TV broadcast cannot bepredicted theoretically with accuracy. To assess the electromagnetic environment due to fixedRF transmitters, an electromagnetic site survey should be considered. If the measured fieldstrength in the location in which the ARTROMOT®-K4 device is used exceeds the applicable RFcompliance level above, the ARTROMOT®-K4 device should be observed to verify normaloperation.If abnormal performance is observed, additional measures may be necessary, such as reorient-ing or relocating the ARTROMOT®-K4 device.

b) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

9.2 Electromagnetic immunityGuidance and Manufacturer’s Declaration – Electromagnetic Immunity

ARTROMOT®-K4 is intended for use in the electromagnetic environment specified below. It isthe responsibility of the customer or user to ensure that the ARTROMOT®-K4 device is used insuch an environment.

Immunity test IEC 60601 testlevel

Compliancelevel

Electromagnetic environment -guidance

Portable and mobile RF communi-cations equipment are used nocloser to any part of theARTROMOT®-K4 device, includingcables, than the recommendedseparation distance calculatedfrom the equation applicable to thefrequency of the transmitter.

Recommended separationdistance:

Conducted RF toIEC 61000-4-6

3 Vrms

150 kHz to80 MHz

3 Vrms d = 1.2 öäP

Radiated RF to IEC61000-4-3

3 V/m80 MHz to2.5 GHz

3 V/m d = 1.2 öäP80 MHz to 800 MHz

d = 1.2 öäP800 MHz to 2.5 GHz

where P is the maximum outputpower rating of the transmitter inwatts (W) according to thetransmitter manufacturer and d isthe recommended separationdistance in meters (m).

Field strengths from fixed RFtransmitters, as determined by anelectromagnetic site survey a, isless than the compliance level ineach frequency range b.

Interference mayoccur in the vicinityof equipment markedwith the followingsymbol.


10. Contact

26

We would be happy to answer anyquestions you may have about ourproducts and services.

� ORMED internationalPlease contact your local dealeror the ORMED headquarters inGermany.

� Headquarters GermanyOrmed GmbH & Co. KGMerzhauser Strasse 112D-79100 Freiburg - GermanyTel. +49/761/45 66-01Fax +49/761/45 66 55-01

� Internetwww.ormed.dee-mail: [email protected]

� Warranty:2 years (mechanical parts)2 years (electroncis)

� SalesOrmed GmbH & Co. KGMerzhauser Strasse 112D-79100 FreiburgGermany

NOTE 1: For calculation of the recommended separation distance of transmitters in the frequencyrange from 80 MHz to 2.5 GHz an additional factor of 10/3 was taken into account to reduce theprobability of mobile/portable communications equipment brought into the patient environment byaccident causing any malfunction.

NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affectedby absorption and reflection from structures, objects, and people.

9.3 Recommended separation distances

Recommended separation distances between portable and mobile RF communications equip-ment and the ARTROMOT®-K4 device

The ARTROMOT®-K4 is intended for use in an electromagnetic environment in which radiated RFdisturbances are controlled. The customer or the user of the ARTROMOT®-K4 device can helpprevent electromagnetic interferences by maintaining a minimum distance between portable andmobile RF communications equipment (transmitters) and the ARTROMOT®-K4 device asrecommended below, according to the maximum output power of the communications equip-ment.

rated maximum outputpower of transmitter W

separation distance according to frequency of transmitterm

150 kHz to 80 MHz

d = 1.2 öäP80 MHz to 800 MHz

d = 1.2 öäP800 MHz to 2,5 GHz

d = 1.2 öäP

0.01 0.12 0.12 0.23

0.1 0.38 0.38 0.73

1 1.2 1.2 2.3

10 3.8 3.8 7.3

100 12 12 23

For transmitters rated at a maximum output power not listed above, the recommended separa-tion distance d in meters (m) can be estimated using the equation applicable to the frequency ofthe transmitter, where P is the maximum output power rating of the transmitter in watts (W)according to the transmitter manufacturer.


27

Do you have any technical questions?Do you need technical service?

Telephone: +49-180-5-1 ormed de+49-180-5-1 67 63 33

Fax: +49-180-5-3 ormed de+49-180-5-3 67 63 33

To prevent damage during transport,only use the original shipping box.These boxes can be obtained fromORMED or from your local dealer.

Before packing the CPM device, set it tothe transport position (see chapter 5).

Refer to the Service Manual for themost recent list of spare parts. TheService Manual can be obtained fromORMED or from your local dealer.

When ordering spare parts, alwaysspecify:

- item

- Description

- Part number

- Qty

- Serial number of the CPM device

Note!Refer repairs to authorized, speciallytrained staff.

11.3 Spare Parts

11.2 Shipment

11.1 Technical Hotline

11. Technical service


28

Declaration of conformity

In compliance with the Council Directive 93/42/EEC of 14 June 1993concerning medical devices, the company

ORMED GmbH & Co. KGMerzhauser Strasse 112

D-79100 Freiburg - Germany

declares that the products of the product line

ARTROMOT® (see Annex)

fulfill the requirements of the Council Directive 93/42/EEC of 14 June 1993,Annex II as well as the essential requirements of Annex I.

With reference to Rule 9 of the Directive 93/42/EEC, these products aredevices of risk class IIa.

Freiburg, January 4th, 2008

- QA Management Representative-

This certificate is valid through: January 4th, 2010.

Annex:

ARTROMOT®-S2 PROARTROMOT®-S3ARTROMOT®-S3 ComfortARTROMOT®-K1ARTROMOT®-K2ARTROMOT®-K2 PROARTROMOT®-K2 PRO ChipARTROMOT®-K3ARTROMOT®-K4ARTROMOT®-SP2ARTROMOT®-SP3ARTROMOT®-E2ARTROMOT®-E2 compactD

EC

LA

RA

TIO

NO

FC

ON

FO

RM

ITIY

DeclarationofConform

itiy

0297


29

LEVEL 1

Extensio(stretching)

speed warm-up protocol Flexion(bending)

LEVEL 2

pause Extension Therapy Time reverse on loadfeature for patient

safety

pause Flexion

LEVEL 3

transport setting new patient total therapy time Service Menu

Symbol overview ARTROMOT®-K4


Notes

30


Notes

31


32

Notes


33

Notes


34

Illustrations for device setup

Fig. 2

Fig. 3

Fig. 6

Fig. 7

Fig. 8Fig. 4

Fig. 5


35

Fold out this page


DIN EN 46 001 ORMED Nr. 018 829-01MOT-323-01/01-1/08

ORMED GmbH & Co. KG • Merzhause r S t raße 112 • D-79100 F re ibu rgTe l +49 761 4566-01 • Fax +49 761 4566-5501 • www.ormed .deE -Ma i l : i n [email protected]


Documents

A-MOT K4 GA engl DV2 801 23.01.2008 12:21 Uhr Seite 1 ... K4... · 2.2 Description of the programming unit 7 ... − Do not use multiple portable socket outlets ... quency ratings