artromot -k1 classic
TRANSCRIPT
Operation ManualUSA/GB
ARTROMOT®-K1 classic
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Device description
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Contents
ARTROMOT®-K1 classic description 3
ARTROMOT®-K1 classic setup illustrations 150
1. How to use the CPM device 29
1.1 Fields of application 291.2 Therapy objectives 291.3 Indications 291.4 Contraindications 29
2. ARTROMOT®-K1 classic description 30
2.1 Description of the device components 302.2 Description of the programming unit 312.3 Explanation of symbols 332.4 Explanation of symbols (connections and nameplate) 34
3. Safety information 35
4. Device setup 38
4.1 Connecting the device, performance check 384.2 Adjusting the device to the femur length 384.3 Adapting the leg support assemblies/footplate 39
5. Setting the treatment values 405.1 General information on programming ARTROMOT®-K1 classic 405.2 Information about the ARTROMOT®-K1 classic therapy parameters 41
6. Care, maintenance, transport 42
6.1 Care 426.2 Maintenance (fuse replacement) 426.3 Transport 43
7. Environmental Protection Statement 43
8. Specifications 43
9. IEC 60601-1-2:2001 44
9.1 Electromagnetic emissions 449.2 Electromagnetic immunity 459.3 Recommended Separation Distances 47
10. How to reach us 47
11. Technical service 48
11.1 Technical hotline 4811.2 Shipment 4811.3 Spare parts 48
12. Declaration of conformity 49
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ARTROMOT®-K1 classic is a motor-operated Continuous Passive Motion(CPM) device used to mobilize kneeand hip joints.
Suitable for use in hospitals, clinics,general practices and rental services, itis an important supplement to medicaland therapeutic treatment.
CPM therapy withARTROMOT®-K1 classic is mainlyused to prevent the negative effectsof immobilization, to allow patients toregain painless mobility of joints at anearly stage and to promote healing andachieve a positive functional result.
Other objectives of therapy include:
- improvement of joint metabolism
- prevention of joint stiffness
- promotion of the regeneration andhealing of cartilage and damagedligaments
- faster hematoma/fluid resorption
- improved lymph and blood circulation
- thrombosis and embolism prophylaxis
1. How to use the CPM device
1.1 Fields of application
1.2 Therapy objectives
The CPM device is indicated in the treat-ment of most injuries and diseases ofthe knee and hip joints as well as in thepostoperative treatment after knee andhip joint surgery. Examples:
- joint distortion and contusion
- arthrotomy and arthroscopy proceduresin combination with synovectomy,arthrolysis or other intra-articularinterventions
- mobilization of joints in anesthetizedpatients
- operative treatment of fractures,pseudoarthrosis and osteotomy
- cruciate ligament replacement orreconstruction
- endoprosthetic implant
Do NOT use ARTROMOT®-K1 classicon patients with:
- acute inflammatory processes inthe joints, unless on the order ofa physician
- spastic paralysis
- unstable osteosynthesis
1.4 Contraindications
1.3 Indications
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7. Clamping lever to adjust the heightof 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 thefootplate
11. Footplate
12. Footplate angle fixation screw
13. Clamping lever to adjust footplaterotation and level and to remove thefootplate
14. Connection for programming unit
15. Connection for power cord
16. Fuse cap
17. Power switch (ON/OFF)
18. Nameplate
19. Programming unit
2. ARTROMOT®-K1 classic description
The motorized CPM device permitsextension and flexion of the knee jointin the range of -10°/0°/120°,and of the hip joint in the range of0°/7°/115°.
It can be used on either side andrequires no configuration change.
These are some of the outstandingARTROMOT®-K1 classic features:
- anatomically correct setup
- physiological movements
- programming unit for preciseadjustment of patient-specifictherapy parameters
- symbols for easy operation of theprogramming unit
Biocompatibility
The parts of theARTROMOT®-K1 classic device thatcome in contact with the patient duringthe intended use, are designed to fulfillthe biocompatibility requirements of theapplicable standards.
Note: Please fold out page 3!
1. Thigh support assembly
2. Clamping lever to adjust the heightof 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
2.1 Description ofthe devicecomponents
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2.2 Description of the programming unit
2.2.1 Programming unit in normal mode
selected angle ofthe CPM device
set flexion value
Flexion control
Pause control
START/STOP key(during operation:LED green,when stopped:LED yellow)
Speed control
Extension control
selected directionof motion
set extensionvalue
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2.2.2 Programming unit in speed or pauseprogramming mode
set value ofselected function(here: speed)
selected function
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2.3 Explanation of symbols
Symbols on the programming unit:
Go to start position
(see Notes in 4.1)
Controls on
programming unit
locked
(see Notes in 5.1)
Controls on
programming unit
unlocked
(see Notes in 5.1)
Service menu
activated, for service
purposes only (also
refer to Service
Manual)
Extension
(stretching the knee)
Flexion
(bending the knee)
Speed
Pause (extension
and flexion)
Symbols that may appear inthe display
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2.4 Explanation of symbols(connections and nameplate)
Alternating current
Protective earth
connection
Type B applied part
Power switch OFF
Power switch ON
Refer to accompanying
documents
Do not dispose product
with unsorted house-
hold or municipal waste.
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Read the safety statements before useof the CPM device. The safety state-ments are classified as follows:
DANGER!Indicates an imminent hazard. Ifnot avoided, this hazard will resultin death or serious injury.
Introduction and definitions
3. Safety information
WARNING!Indicates a hazard. If not avoided,this hazard can result in death orserious injury.
CAUTION!Indicates a potential hazard. Ifnot avoided, this hazard can resultin minor personal injury and/orproduct/property damage.
Safety information
WARNING!Patient hazard –
- Only authorized individualsare allowed to operate theARTROMOT®-K1 classic device.Individuals are authorized afterreceiving training in the operationof the device and reading thisoperation manual.
- Before using the device, theoperator must ascertain that itis in correct working order andoperating condition. In particular,the cables and connectors mustbe checked for signs of damage.Damaged parts must be replacedimmediately, with original spareparts.
- Before therapy, a test runconsisting of several exercisecycles must be completed, firstwithout and then with the patient.Check that all fixation screws aretightened.
- Stop therapy immediately, whenyou have doubts about the devicesettings and/or the therapy protocol.
DANGER!Explosion hazard –
ARTROMOT®-K1 classic is notdesigned for use in areas wherean explosion hazard may occur.An explosion hazard may resultfrom the use of flammable anesthe-tics, skin cleansing agents anddisinfectants.
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WARNING!Patient hazard –
- It is important that the patient'sposition is anatomically correct.Therefore, carefully verify thefollowing settings/positions:
1. femur length2. knee joint axis3. tibia length and leg rotation4. leg support assemblies
- Movements must not cause painor irritation.
- Patients must be fully consciouswhile being instructed in the useof the CPM device and duringtherapy.
- Only the responsible physicianor therapist is able and allowedto choose the therapy parametersto use. It is the physician's ortherapist's decision whether ornot to use the CPM device ona specific patient.
- The patient must be familiarwith the functions of theARTROMOT®-K1 classicprogramming unit and the unitmust be within easy reach of thepatient, allowing him or her tostop therapy, if needed. Patientsunable to operate the program-ming unit, e.g. paralytic patients,must never be left unattendedduring therapy.
- Any accessories used withARTROMOT®-K1 classic mustfirst be approved by ORMED.
- Do not allow parts of the bodyor objects (such as blankets,cushions, or cables) to get caughtin the moving parts of the CPMdevice.
WARNING!Shock hazard –Strictly observe the followingwarnings. Failure to do so endangersthe lives of the patient, the user andother persons involved.
- Allow ARTROMOT®-K1 classicto reach room temperature beforeuse. If the device has been trans-ported at temperatures below0 °C/ 30°F), leave it to dry atroom temperature for about 2hours, until any condensationhas disappeared.
- The ARTROMOT®-K1 classicdevice must only be operatedin dry rooms.
- When disconnecting the devicefrom the power line, remove theplug from the wall outlet first,before disconnecting the cablefrom the device.
- When connecting the device toother equipment or when creatinga medical system, check that thesum of leakage currents will notcause any hazard. Please contactORMED, if you have questions inthis matter.
- Do not use multiple portablesocket outlets (MPSO) to connectthe device to the power line.ARTROMOT®-K1 classic must beconnected to a properly installedwall outlet with a non-fusedearthed wire. Before connectingthe power cord, it must be com-pletely unrolled and placed suchthat it will not get caught by themoving parts of the device.
- Before cleaning and service inter-ventions, disconnect the devicefrom the power line by removingthe power cord from the walloutlet.
- Liquids must not be allowedto enter the CPM device or theprogramming unit. If liquids haveentered into the devices,ARTROMOT®-K1 classic must beimmediately checked by a servicetechnician, before it can be reused.
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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 require-ments. X-ray equipment, MRIdevices and radio systems arepossible sources of interferenceas they may emit higher levels ofelectromagnetic radiation. Keepthe CPM device away from thesedevices and verify its performancebefore use.
- Refer repair and maintenance toauthorized persons.
- Route all cables below the deviceframe to either side, ensuringthat they cannot get caught bythe moving parts during operati-on.
- Inspect ARTROMOT®-K1 classicfor damage and loose connectionsat least once a year. Damagedand worn parts must immediatelybe replaced with original spareparts by authorized staff.
CAUTION!Preventing chafing and pressuresores –
When your patient is adipose,very tall or very short, be sureto prevent chafing and pressuresores. Place the leg concerned ina moderate abduction position, ifdeemed appropriate.
CAUTION!Equipment damage –
- Check that the voltage andfrequency ratings of your localpower line are those indicatedon the nameplate.
- The leg support element with-stands a maximum continuousload of 20 kg.
- Do not allow any objects (suchas blankets, cushions, or cables)to get caught in the moving partsof the CPM device.
- Do not expose theARTROMOT®-K1 classic device todirect sunlight, because someof the components may reachinadmissibly high temperatures.
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4. Device setup
ARTROMOT®-K1 classic enters thehome position (for home positionvalues, refer to section 4.1), the devicehas passed the performance check.
The device also runs performancechecks regularly during operation. Thisis what happens, if a problem is identified:
- An audio signal sounds.- The device switches off immediately.- The message “ERROR”, accompanied
by a code number (e.g. ERROR 5),appears on the display.
In this situation, you may attempt torestart the device by turning the devicebriefly off and on again with the powerswitch. If the error message persists,have the device inspected by a Servicetechnician, before using it again.
Note: For a better understandingof each step, please fold out pages3 and 150.
1. Connect the power cord to socket(15) of the device and mains plug toa wall outlet with a non-fused earthedwire (100 to 240 Volt, 50/60 Hz).
2. Turn the power switch (17) on.
3. Follow these steps to set the carriageto the home position.
Press the Extension key
and, holding it depressed, rotateuntil 30° appears in the displayabove the control.
In the same manner, select aFlexion value of 35°.
Then press the START/STOP key.
When the carriage has reached thisrange and does not stop automati-cally, press the START/STOP keyagain to stop any movement.
If the programming unit can beoperated as described above and
Performance check
4.1 Connecting thedevice, performancecheck
Note!ARTROMOT®-K1 classic will stopautomatically in the home positionrange, only if it was positionedoutside this range (30° to 35°) atthe time of programming (alsorefer to 5.2)
4.2 Adjusting the deviceto the femur length
1. Measure the length of the patient'sthigh (femur) from the greatertrochanter to the lateral knee jointcavity (Fig. A).
2. Set the carriage to the home position(see 4.1).
3. Set the measured value at thefemur scale (3) of the carriage.
- Loosen the two fixation screws (4).
- Extend the scale (3) to the requiredlength.
- Tighten the fixation screws (4) toset the scale to the new length.
CAUTION!Equipment damage –
Do not attempt to extend thefemur scale beyond the stop.
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4.3 Adapting the legsupport assem-blies/footplate
1. Set the leg support assemblies andthe footplate (1, 6, 11) to the expectedpositions before accommodating thepatient.
- Loosen fixation screws (8) to adjustthe footplate (11) to the length of thepatient's lower leg (Fig. C).
Loosen clamping lever (13) andadapt the footplate's rotation andheight to the patient (Fig. D).
Loosen fixation screw (12) and adaptthe angle to the patient's foot (turnthe screw a few revolutions until thefootplate can be easily adjusted).
For short patients you can reversethe footplate's bracket 180° (Fig. H)to adapt the footplate to shortercalves:
• Loosen clamping lever (13) andremove the footplate (11).
• Loosen the fixation screws (12).
• Reverse the bracket 180°.
• Screw the footplate to the bracketand tighten the clamping lever.
- To adjust the height of the supportassemblies for calf (1) and thigh(6), loosen clamping levers (2) and (7)(Figs. E/F).
2. Place the patient’s leg on the carria-ge and repeat the steps outlinedunder 1 above to adjust the deviceto the patient.
Note!When reversing the footplate,ensure that the pins below theclamping lever engage with therecesses in the bracket.
CAUTION!Equipment damage –
Cover the leg support assemblieswith disposable tissues whenusing ARTROMOT®-K1 classicimmediately after surgery.This helps prevent discoloration.
Symbol 1:Measurement of thepatient's femur lengthfrom the greatertrochanter to theknee joint cavity
Symbol 2:Set the carriage tothe home position(see 4.1) and adjustit to the measuredfemur length.
Symbol 3:Adjust height of calfand thigh supportassemblies. Adjustthe footplate to theheight and length ofthe lower leg.
CAUTION!Patient hazard –
Ensure that the rotational axes ofthe CPM device and of the kneejoint coincide both in the verticaland in the horizontal plane (Fig. G).
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5. Setting the treatment values
When adjusting speed or pause,the information shown in the displaychanges automatically as you pressthe control.
The selected parameter (speed orpause) is immediately representedby its symbol in a large format plusthe current value (also refer to 2.2.2).
The current value can be changedby turning the depressed control.
When you have set the new value,release the control and the standarddisplay reappears automatically afterapprox. 5 seconds (see also 2.2.1).
3. Subsequently press theSTART/STOP key to start therapy.
1. You activate a function bybriefly pressing a control onthe programming unit.
2. You select a treatment value bypressing the respective controland turning it in either direction.
You increase a value by turning thecontrol clockwise towards the +(plus) symbol and you decrease avalue by turning the control counter-clockwise towards the - (minus)symbol.
For the first 5° the values in the dis-play change in steps of 1°, then theinterval changes to 5° so that youreach the target value faster.
During adjustment of the extensionand flexion angles, the values in thedisplay change as you turn the con-trol after pressing it.
WARNING!Patient hazard –
Before therapy, a test runconsisting of several exercisecycles must be completed withoutthe patient. Then repeat the test runwith the patient and check that themovement does not cause any pain.
5.1 General informationon programmingARTROMOT®-K1classic
Note!See also 2.2 and 2.3 as well aspage 150!
Note!Refer to sections 5.2 fora description of the parameters.
- To prevent accidental changes ofthe parameter settings, lock theprogramming unit by simulta-neously pressing the "Extension"and "Speed" controls.
Press both controls again tounlock.
- Emergency stop function:ARTROMOT®-K1 classic will stopimmediately, when any of the keysis pressed during therapy. Patienttreatment can be resumed bypressing the START/STOP key.The device will automaticallychange the direction.
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5.2 Information aboutthe ARTROMOT®-K1classic therapyparameters
■ Speed
The speed can be adjusted between5 % and 100 % in steps of 5 %.Default setting: 50 %
■ Pauses
Pauses occur at the selected limitswhere stretching turns into bendingand bending into stretching (selectedextension and flexion values).The value entered applies to bothextension and flexion pause.
Pauses can be set to any value bet-ween 0 and 59 seconds in steps of 1second, and to values between 1and 59 minutes in steps of 1 minute.
When selecting the seconds, thevalue changes in 1-second steps forthe first five seconds. Subsequentlythe interval changes to 5-secondsteps.
The minutes are always adjusted in1-minute steps.Default setting: no pause
Note!The programmed value and thevalue measured at the patient'sknee may deviate slightly.
- If the carriage is positionedwithin the programmed rangeof motion at the time therapybegins, the therapy session willstart immediately.
If the carriage is positionedoutside the programmed rangeof motion at the time therapystarts, it will first enter the position“extension +10°”. The carriagewill stop in this position and youcan initiate the therapy sessionby pressing the START/STOPkey again.
- You select a function by pressing thecorresponding control
- You change the treatment values byturning the depressed control.
- You initiate the treatment session bypressing the START/STOP key
■ Extension (streching)
- Maximum knee extension:-10 degrees
- Maximum hip extension:7 degrees
■ Flexion (bending)
- Maximum knee flexion:120 degrees
- Maximum hip flexion:115 degrees
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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 allcomponents for damage and looseconnections 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 checks can be carried out byORMED within the framework of aservice agreement.Contact ORMED for details.
The device does not require additionalregular maintenance.
- ARTROMOT®-K1 classic can bedisinfected by wiping down with adisinfectant. Thus, it complies with thespecial hygiene standards for medicaltechnical equipment.
- The enclosure and removable legsupport assemblies can be cleanedwith commonly used disinfectantsand mild household detergents.
- Use only a damp cloth to wipethe carriage down.
Clean the sheath of the programmingunit on a regular basis. Remove itfrom the programming unit beforecleaning. Allow the sheath to drybefore inserting the programmingunit again.
6. Care, maintenance, transport
6.1 Care
CAUTION!Equipment damage –
- The plastic material used is notresistant to mineral acids, formicacid, phenols, cresols, oxidizingagents and strong organic orinorganic acids with a pH valuebelow 4.
- Use only clear disinfectantsto prevent discoloration of thedevice.
- Do not expose the CPM deviceto strong ultraviolet radiation(sunlight) and fire.
6.2 Maintenance(fuse replacement)
Check before each use
Technical Inspections
WARNING!Shock hazard –
Unplug the device from the powerline before cleaning.
Shock hazard, equipment damage –Liquids must not enter the deviceor the programming unit.
Fuse replacement
WARNING!Patient hazard, equipmentmalfunction and damage –
The replacement of fuses mustbe referred to specialists as definedin IEC 60364 or similar standards(e.g. biomedical technicians,electricians, electronics installers).
Fuses used must be T1A fuses.
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The product described in this operationmanual must not be dispose of withunsorted household or municipal waste.It requires separate disposal. Pleasecontact ORMED for information aboutthe possible recycling of the product.
Input ratings: 100 – 240 V AC/50 – 60 Hz
Currentconsumption: 850 – 370 mA
Fuses: 2 x T1A
Protection class: I
Applied part: type B
Max. loadon carriage: 20 kg
Dimensionslength: 96 cmwidth: 35 cmheight: min. 23 cm to
max. 56 cm
Adjustment ranges (min./max.):Femur range: approx. 31 – 49 cm
Lower leg range: approx. 25 – 57 cm
Weight: 11 kg
Materials used: ABS, POM(Delrin 100),PUR, PA, FR4,aluminium, stainlesssteel, brass
MDD class 2a
Standards compliance:IEC 60601-1:1988+ A1:1991+ A2:1995
Certification: ANSI/UL 60601-1CAN/CSA C22.2No. 601.1
7. Environmentalprotection statement
8. Specifications
Follow these steps to prepare theARTROMOT®-K1 classic for transport:
1. Adjust the femur length to 49 cmand the tibia length to 45 cm.
2. Set the carriage to 0° by pressingthe START/STOP key when thecarriage is in the 0° position. Thiswill stop the carriage in that position
3. Push the power switch to turn offthe ARTROMOT®-K1 classic.
4. Disconnect the power cord and theprogramming unit.
5. The device must be stored in itsoriginal shipping box for transport.ORMED GmbH & Co. KG cannot beheld liable for damage in transit, ifthe original shipping box was not used.
6. Inser the programming unit intothe space provided in the moldedpolystyrene pads and secure withadhesive tape.
7. Set the footplate to a horizontalposition.
8. Now slide the polystyrene padsonto the ARTROMOT®-K1classic.
9. Place the power cord at thebottom of the box before insertingthe ARTROMOT®-K1 classic includingthe polystyrene pads.
6.3 Transport
Programming Unit Power Cord
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ARTROMOT®-K1 classic should notbe used adjacent to or stacked withother equipment.If adjacent or stacked use is necessary,ARTROMOT®-K1 classic should beobserved to verify normal operation inthe configuration in which it will be used.
We can guarantee the specified electro-magnetic emission and immunity dataonly if the manufacturer's original spareparts are used in repair and maintenanceof the device.
The ARTROMOT®-K1 classic device issubject to particular precautions regar-ding electromagnetic compatibility(EMC). The device must be installed andput into service strictly in compliancewith the EMC directives put forth in theaccompanying documents.
Portable and mobile RF communicationsystems may affect the ARTROMOT®-K1classic device.
9. IEC 60601-1-2:2001
Electromagnetic environment –guidance
ARTROMOT®-K1 classic uses RF energyonly for its internal function. Therefore, itsRF emissions are very low and are notlikely to cause any interference in nearbyelectronic equipment.
ARTROMOT®-K1 classic is suitable foruse in all establishments, including domesticand those directly connected to the publiclow-voltage power supply network thatsupplies buildings used for domesticpurposes.
Guidance and Manufacturer’s Declaration – Electromagnetic EmissionsARTROMOT®-K1 classic is intended for use in the electromagnetic environmentspecified below. It is the responsibility of the customer or user to ensure that theARTROMOT®-K1 classic device is used in such an environment.
Emissions test
RF emissions toCISPR 11
RF emissions toCISPR 11
Harmonic emissions toIEC 61000-3-2
Voltagefluctuations/flicker emis-sions to IEC 61000-3-3
9.1 Electromagnetic emissions
Compliance
Group 1
Class B
not applicable
not applicable
EMC IEC 60601-1(electromagnetic 2:2001compatibility)
Ambient conditions(storage, transport)temperature: -24 ºC to +60 ºC
(-12 °F to +140 °F)
relative humidity: 20 % to 85 %
atmosphericpressure: 700 hPa to
1060 hPa
Ambient conditions (operation)temperature: +10 ºC to +40 ºC
(50 °F to +104 °F)
relative humidity: 30 % to 75%
atmosphericpressure: 700 hPa to
1060 hPa
Subject to change without notice.(08/06)
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Electromagneticenvironment - guidance
Floors should be wood,concrete or ceramic tile.If floors are covered withsynthetic material, therelative humidity shouldbe at least 30%.
Mains power should bethat of a typical commercialor hospital environment.
Mains power should bethat of a typical commercialor hospital environment.
Mains power should bethat of a typical commercialor hospital environment.If the user of theARTROMOT®-K1 classicdevice requires continuedoperation during powermains interruptions, it isrecommended that theARTROMOT®-K1 classicdevice be powered from anuninterruptible power supp-ly or a battery.
Power frequency magneticfields should be at levelscharacteristics of a typicallocation in a typicalcommercial or hospitalenvironment. Portable andmobile RF communicationsequipment are used nocloser to any part of theARTROMOT®-K1 classicdevice, including cables,than the recommendedseparation distance calcula-ted from the equation appli-cable to the frequency ofthe transmitter.
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
ARTROMOT®-K1 classic is intended for use in the electromagnetic environment specifiedbelow. It is the responsibility of the customer or user to ensure that the ARTROMOT®-K1classic device is used in such an environment.
Immunity test
Electrostaticdischarge (ESD)to IEC 61000-4-2± 6 kV contact
Electrical fast transi-ent/burst to IEC61000-4-5± 2 kV forpower supply lines
Surges to IEC61000-4-5
Voltage dips, shortinterruptions andvoltage variationson power supplyinput lines to IEC61000-4-11
Power frequency(50/60 Hz) magneticfield to IEC 61000-4-8
9.2 Electromagnetic immunity
Compliance level
e 6 kV contact
e 8 kV air
e 2 kV for powersupply lines
e 1 kV for input/out-put lines
e 1 kV differentialmode
e 2 kV commonmode
< 5% UT(> 95% dip in UT ) for ) cycle
40% UT(60% dip in UT) for5 cycle
70% UT(30% dip in UT) for25 cycles
< 5% UT(> 95% dip in UT)for 5 s
3 A/m
NOTE: UT is the a.c. mains voltage prior to application of the test level.
IEC 60601-testlevel
e 6 kV contact
e 8 kV air
e 2 kV for powersupply lines
e 1 kV forinput/output lines
e 1 kV differentialmode
e 2 kV commonmode
< 5% UT(> 95% dip in UT ) for ) cycle
40% UT(60% dip in UT)for 5 cycle
70% UT(30% dip in UT)for 25 cycles
< 5% UT(> 95% dip in UT)for 5 s
3 A/m
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Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
ARTROMOT®-K1 classic is intended for use in the electromagnetic environment specifiedbelow. It is the responsibility of the customer or user to ensure that the ARTROMOT®-K1classic device is used in such an environment.
Immunity test
Conducted RF toIEC 61000-4-6
Radiated RF toIEC 61000-4-3
IEC 60601test level
3 Vrms
150 kHz to 80 MHz
3 V/m80 MHz to 2.5 GHz
Compliance level
3 Vrms
3 V/m
Electromagnetic environ-ment-guidance
Recommended separationdistance:
d = 1.2örP
d = 1.2örP 80 MHz to
800 MHz
d = 2.3örP 800 MHz to
2.5 GHz
where P is the maximum outputpower rating of the transmitterin watts (W) according to thetransmitter manufacturer andd
is the recommended separationdistance in meters (m).
Field strengths from fixed RFtransmitters, as determined byan electromagnetic site survey a,is less than the compliancelevel in each frequency rangeb.
Interference may occur in thevicinity of equipment markedwith the following symbol
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagationis affected by 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 cannotbe predicted theoretically with accuracy. To assess the electromagnetic environment dueto fixed RF transmitters, an electromagnetic site survey should be considered. If the mea-sured field strength in the location in which the ARTROMOT®-K1 classic device is usedexceeds the applicable RF compliance level above, the ARTROMOT®-K1 classic deviceshould be observed to verify normal operation. If abnormal performance is observed,additional measures may be necessary, such as reorienting or relocating theARTROMOT®-K1 classic device.
b) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
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The ARTROMOT®-K1 classic is intended for use in an electromagnetic environmentin which radiated RF disturbances are controlled. The customer or the user of theARTROMOT®-K1 classic device can help prevent electromagnetic interferences bymaintaining a minimum distance between portable and mobile RF communications equip-ment (transmitters) and the ARTROMOT®-K1 classic device as recommended below,according to the maximum output power of the communications equipment.
rated maximum outputpower of transmitter
W
NOTE 1: For calculation of the recommended separation distance of transmitters in thefrequency range from 80 MHz to 2.5 GHz an additional factor of 10/3 was taken intoaccount to reduce the probability of mobile/portable communications equipment broughtinto the patient environment by accident causing any malfunction.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagationis affected by absorption and reflection from structures, objects, and people.
9.3 Recommended separation distances between portable and mobile RFcommunications equipment and the ARTROMOT®-K1 classic device.
separation distance according to frequency of transmitterm
150 kHz to 80 MHz
d = 1.2örP
0.12
0.38
1.2
3.8
12
For transmitters rated at a maximum output power not listed above, the recommendedseparation distance d in meters (m) can be estimated using the equation applicable to thefrequency of the transmitter, where P is the maximum output power rating of the transmitterin watts (W) according to the transmitter manufacturer.
80 MHz to 800 MHz
d = 1.2örP
0.12
0.38
1.2
3.8
12
800 MHz to 2,5 GHz
d = 2.3örP
0.23
0.73
2.3
7.3
23
0.01
0.1
1
10
100
We would be happy to answer anyquestions you may have about ourproducts or services.
■ ORMED internationalPlease contact your local dealer orthe ORMED headquarters in Germany.
■ Headquarters GermanyORMED GmbH & Co. KGMerzhauser Straße 11279100 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 (electronics)
Sales:ORMED GmbH & Co. KGMerzhauser Straße 112D-79100 Freiburg
10. How to reach us
48
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.
Before packing the CPM device, set it tothe transport position (see chapter 6.3).
Refer to the Service Manual forthe most recent list of spare parts.
When ordering spare parts, alwaysspecify:
- item
- description
- part number
- quantity
- serial number of the CPM device
Surcharges may apply in certain casesto spare parts ordered in low quantities.
11. Technical service
11.1 Technical hotline
11.3 Spare parts
Note!Refer repairs to authorized,specially trained staff.
ORMED GmbH & Co. KG offersservice training for your personnel.
11.2 Shipment
Eng
lish
49
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
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.
Freiburg, August 28th, 2006
- QA Management Representative-
Annex:
ARTROMOT®-S2 PROARTROMOT®-S3ARTROMOT®-S3 ComfortARTROMOT®-K1ARTROMOT®-K2ARTROMOT®-K2 PROARTROMOT®-K2 PRO ChipARTROMOT®-K3ARTROMOT®-K4ARTROMOT®-SP2ARTROMOT®-E2ARTROMOT®-E2 compactD
EC
LA
RA
TIO
NO
FC
ON
FO
RM
ITIY
0297
150
A
C
E
B
D
F
ARTROMOT®-K1 classic setup illustrations
G H
© O
RMED
806
DIN EN 13485 ORMED Nr. 018 829-01
ORMED GmbH & Co. KG • Merzhauser Straße 112 • D -79100 Fre iburgTe l +49 761 4566-01 • Fax +49 761 4566-5501 • www.ormed.de E-Mail: [email protected]