K4 Knee CPM Owner`s Manual (SN>10000)
Contents
1. Electrical fast x 2 kV for power x 2 kV for power Mains power should be that of a transient burst supply lines supply lines typical commercial or hospital eins tar 1 KV for environment input output lines input output lines Surges to 1 kV differential 1 kV differential Mains power should be that of a IEC 61000 4 5 mode mode typical commercial or hospital x 2 kV common x 2 kV common environment mode mode Voltage dips lt 5 Ur lt 5 Ur Mains power should be that of a short interrup gt 95 dip in Uy gt 95 dip in Uy typical commercial or hospital tions and for V cycle for Y cycle environment If the user of the T eS voltage varia 40 U 40 U ARTROMOT K device requires tions on power supply input lines to IEC 61000 4 11 60 dip in Uy for 5 cycles 70 Ur 30 dip in U for 25 cycles lt 5 Ur gt 95 dip in Uy for5s 60 dip in Uy for 5 cycles 70 Ur 30 dip in U for 25 cycles lt 5 Ur gt 95 dip in Uy for5s continued operation during power mains interruptions it is recom mended that the ARTROMOT K4 device be powered from an uninter ruptible power supply or a battery Power frequency 50 60 Hz magnetic field to IEC 61000 4 8 3 A m 3 A m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment NOTE U is the a c mains vo2. 1 How to use the CPM device 1 1 Fields of application 1 3 Indications ARTROMOT K4 is a motor operated Continuous Passive Motion CPM device providing motion to the shoulder joint Suitable for use in hospitals clinics general practices and rental services it is an important supplement to medical and therapeutic treatment 1 2 Therapy objectives CPM therapy with ARTROMOT K4 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 functio nal result Other objectives of therapy include improvement of joint metabolism prevention of joint stiffness promotion of the regeneration and healing 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 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 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 anesthetized patients operative treatment of fractures pseudoarthrosis and corrective osteotomy cruciate ligament
3. Before using the device the opera tor 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 consis ting of several exercise cycles must be completed first without and then with the patient Check that all Setting screws are tightened Stop therapy immediately when you have doubts about the device settings and or the therapy protocol It is important that the patient s position is anatomically correct Check the following settings posi tions 1 femur length 2 knee joint axis 3 lower leg length and rotational position of the leg 4 patient kits Movements must not cause any pain or irritation Patients must be fully conscious while being instructed in the use of the CPM device and during therapy The choice of the therapy parame ters to program and of the therapy protocols to use is restricted to the responsible physician or therapist It is the physician s or therapist s decision whether or not to use the CPM device on a specific patient The patient must be familiar with the functions of the ARTROMOT K4 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
4. 25 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 at the frame around the foot Caution Patient hazard The reverse on load feature is a safety measure to protect the patient in the event of cramps spasms locked joints and similar situations The manufacturer cannot be held liable for misuse of this feature LEVEL 3 Kiel With this function the carriage will move to a position optimally suited for packing the CPM device Select the function and press the START key The carriage moves to the transport position E Transport setting E New patient 0 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 The new patient function home position selects the following settings extension 25 flexion 35 Speed 100 warm up disabled extension pause 0 flexion pause 0 timer continuous operation reverse on load 25 45 kp total therapy time 0 19 2 0 The total therapy time is the added sum of operating hours E Total therapy time If the device is used by only one patient this time is equivalent to the duration of
5. Environmental Protection Statement The product described in this operation manual must not be disposed of with unsorted household or municipal waste It requires separate disposal Please contact ORMED or your local dealer for information about the possi ble recycling of the product 8 Specifications Input ratings 100 240 V AC 50 60 Hz Current consumption 850 370 mA Fuses 2x TIA slow blow Protection class I IP degree of protection IPXO Applied part type B Max load on carriage 30 kg 66 13 Ib 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 approx 39 5 56 cm 15 55 22 04 in 13 kg 28 66 Ib lower leg range Weight Materials used ABS POM Delrin 100 PUR PA FR4 aluminum stainless steel brass Steel 1 4301 1 4305 1 4310 MDD class 2a 22 Standards IEC 60601 compliance 1 1988 A1 1991 A2 1995 Certification ANSI UL 60601 1 CAN CSA C22 2 No 601 1 EMC IEC 60601 1 electromagnetic 2 2001 compatibility Ambient conditions storage transport Ambient temperature 24 C to 60 C 50 to 104 F 20 96 to 85 96 700 hPa to 1060 hPa Relative humidity Atmospheric pressure Ambient conditions operation Ambient temperature 10 C to 40 C 50 to 104 F Relative humidity 30 to 75
6. Atmospheric pressure 700 hPa to 1060 hPa Subject to change without notice 10 07 9 IEC 60601 1 2 2001 The ARTROMOT K4 device is subject to particular precautions regarding electromagnetic compatibility EMC The device must be installed and put into service strictly in compliance with the EMC directives put forth in the accompanying documents Portable and mobile RF communication systems may affect the ARTROMOT K4 device The ARTROMOT K4 device should not be used adjacent to or stacked with other equipment If adjacent or stacked use is necessary ARTROMOT K4 should be observed to verify normal operation in the configuration in which it will be used If you detect damage or malfunctions that may impair the safety of the patient or of the operator have the device repaired before using it If it is necessary to replace assemblies or cables only the manufacturer s original parts may be used to ensure continued compliance with EMC requirements after repair This require ment applies to the power supply unit cables and cable lengths drive unit consisting of the motor and the control system the programming unit incl the coiled cable and the connector 9 1 Electromagnetic emissions Guidance and Manufacturer s Declaration Electromagnetic Emissions an environment ARTROMOT K4 is intended for use in the electromagnetic environment specified below It is the responsibility
7. all the patient s therapy sessions Deleting the stored therapy time Press and hold the parameter key for 5 seconds or select the New Patient function E Service menu IC For service purposes only refer to Service Manual Reminder You save the selected parameter values by pressing the STOP key 6 Care Maintenance 6 1 Care 6 2 Maintenance fuse replacement Warning Shock hazard Remove the power cord from the wall outlet before cleaning Shock hazard equipment damage Liquids must not enter the device or the programming unit ARTROMOT K4 can be disinfected by wiping down with a disinfectant Thus it complies with the special hygiene standards for medical technical equipment The enclosure can be cleaned with common disinfectants and mild household cleaning agents Only use a damp cloth to wipe the CPM device down Caution Equipment damage The plastic material used is not resistant to mineral acids formic acid phenols cresols oxidants and strong organic or inorganic acids with a pH value below 4 Use only clear disinfectants to prevent discoloration of the device Do not expose the CPM device to strong ultraviolet radiation sunlight and fire Do not use cleaning agents that contain chloride 20 Check before each use Visually inspect the device for signs of mechanical da
8. de E Mail info ormed de ORME IDEAS IN MOTION
9. g paralytic patients must never be left unattended during therapy All accessories used with the ARTROMOT K4 device must first be approved by ORMED Do not allow parts of the body or any objects such as blankets cushions or cables to get caught in the moving parts of the CPM device 12 A Warning Shock hazard Strictly observe the following war nings Failure to do so endangers the lives of the patient the user and other persons involved Before use allow the ARTROMOT K4 to reach room temperature If the device has been transported at temperatures below 0 C 32 F leave it to dry at room temperature for about 2 hours until any condensation has disappeared The ARTROMOT K4 device must only be operated in dry rooms When disconnecting the device from the power line remove the plug from the wall outlet first before disconnecting the cable from the device When connecting the device to other equipment or when creating a medical system check that the sum of leakage currents will not cause any hazard Please contact ORMED if you have questions in this matter Do not use multiple portable socket outlets MPSO to connect the device to the power line ARTROMOT K4 must be connec ted 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 ge
10. of the customer or user to ensure that the ARTROMOT K4 device is used in such Emissions test Compliance Electromagnetic environment guidance RF emissions to CISPR 11 Group 1 ARTROMOT K4 uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions to CISPR 11 Class B ARTROMOT K4 is suitable for use in all establishments including domestic and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Harmonic emissions to IEC not applicable 61000 3 2 Voltage fluctuations flicker not applicable emissions to IEC 61000 3 3 23 9 2 Electromagnetic immunity Guidance and Manufacturer s Declaration Electromagnetic Immunity ARTROMOT K4 is intended for use in the electromagnetic environment specified below It is the responsibility of the customer or user to ensure that the ARTROMOT K4 device is used in such an environment Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Electrostatic discharge ESD to IEC 61000 4 2 x 6 kV contact 8 KV air 6 KV contact x 8 KV air Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 3096
11. on the carriage and adjust the height with the help of the Velcro tapes and by repeating the steps at 1 Ensure that the exercise will only be performed in a range of motion that does not cause any pain and provides maximum comfort for the patient 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 8 5 Setting the treatment values 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 Note See also 2 2 and 2 3 as well as page 29 5 1 General information on programming ARTROMOT K4 1 You activate the programming mode by briefly pressing the MENU key on the programming unit 2 The treatment parameters and functions are allocated to four pro gramming levels four per level To be able to program a parameter you will have to access the corres ponding 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 If you wish to return to the previous programming level e g from level 3 to 2 press the MENU key and hold it pressed for a sh
12. patient total therapy time service menu 2 4 Explanation of symbols connections and nameplate Alternating current Protective earth connection t Type B applied part O Power switch OFF Power switch ON AN Refer to accompanying documents Pd Do not dispose of product with unsorted household or municipal waste 10 3 Safety information Definitions Read the safety statements before use of the CPM device The safety state ments are classified as follows A Danger This term indicates an imminent hazard If not avoided this hazard will result in death or serious injury A Warning This term indicates a hazard If not avoided this hazard can result in death or serious injury Caution indicates a potential hazard If not avoided this hazard can result in minor personal injury and or pro duct property damage Safety information Danger Explosion hazard ARTROMOT K4 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 Warning Patient hazard Only authorized individuals are allowed to operate the ARTROMOT K4 device Individuals are authorized after receiving training in the operation of the device and reading this operation manual
13. ARTROMOT K4 Operation Manual Starting with serial number higher than 10000 Fold out this page Device description 21 20 19 18 17 16 15 14 13 12 Contents Device description Symbol overview ARTROMOT K4 Illustrations for device setup 1 How to use the CPM device 1 1 Fields of application 1 2 Therapy objectives 1 3 Indications 1 4 Contraindications 2 Description of the ARTROMOT K4 2 1 Description of the device components 2 2 Description of the programming unit 2 3 Explanation of symbols 2 4 Explanation of symbols connections and nameplate 3 Safety information 4 Device setup 4 1 Connecting the device performance check 4 2 Mechanical Settings 4 3 Adjusting the Patient Kit 5 Setting the treatment values 5 1 General information on programming ARTROMOT K4 5 2 Programming ARTROMOT K4 5 3 Therapy parameter details 6 Care Maintenance 6 1 Care 6 2 Maintenance fuse replacement 6 3 Conversion 7 Environmental Protection Statement 8 Specifications 9 IEC 60601 1 2 2001 9 1 Electromagnetic emissions 9 2 Electromagnetic immunity 9 3 Recommended separation distances 10 Contact 11 Technical service 11 1 Technical Hotline 11 2 Shipment 11 3 Spare Parts Declaration of Conformitiy 29 34 NOOO Om Om O1 O1 O1 oo mb Ki hn N cock ae ck bt ek 2000 JJ OO Om P SP N N D N N NN ND OO E WwW D o h MM NN A d D
14. ay have to be reconfigured from left to right With this reconfiguration feature the anatomical accuracy of the carriage is outstanding 1 To begin with set the carriage to a knee angle of 80 to 90 see also 5 1 and stop it there 2 Pull on the locking pin 11 for the height adjustment of the carriage hip pivot and remove the height adjust ment from the carriage Fig 9 3 Hold the height adjustment Remove the entire femur length adjustment 8 mechanism To do so open the bayonet lock by turning it a quarter revolution and pull the mechanism from the holding tube Fig 10 4 Attach the femur length adjustment mechanism on the other side To do so observe the instructions given at 3 reversing the order 21 Note For the correct assembly and locking of the bayonet lock please observe the sticker on the ARTROMOT K4 5 Now press the buttons 13 simulta neously and pull the length adjust ment for the hip height adjustment from the carriage housing Fig 11 6 Then insert the length adjustment for the hip height adjustment into the carriage housing on the other side until you hear it engage 7 Pull on the locking pin 11 for the height adjustment of the carriage hip pivot and reinsert the height adjustment into the holding tube When the correct height is reached release the locking pin to fix the set height Fig 12 7
15. ip axis pivot point 11 Locking pin for high adjustment of hip 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 2 Description of the programming unit 2 2 1 Programming unit in normal mode current carriage angle selected therapy therapy timer mes ARTROMOT set extension set flexion value value current direction of motion parameter keys MENU key plus key O E 1 START key minus key O amp gt STOP key 2 2 2 Programming unit in MENU selection mode set carriage angle for selected MENU level internal external rotation set extension value set flexion value parameters available for selection corres ponding selection keys 2 2 3 Programming unit in programming mode selected function status of the selected function here flexion angle selected parameter here flexion 2 3 Explanation of symbols Also refer to symbol overview on page 29 30 gt 0 20 extension stretching the knee flexion bending the knee speed warm up protocol extension pause flexion pause therapy timer reverse on load feature for patient safety transport setting new
16. justing the height of the carriage hip pivot to the level of the patient s greater trochanter Now re insert the locking pint 11 8 Adapting the carriage to the femur length Fig 2 e Press on the locking pin at the femur length adjustment 9 to release the lock e Adjust the appropriate femur length 8 Fix the setting by releasing the locking pin 9 Caution Equipment damage Please do not try to pull out the femur length adjustment past the stop 4 Adapting the carriage to the tibia length Fig 3 Loosen the two fixation screws 4 Adjust the appropriate tibia length The setting should exactly match the length of the patient s lower leg Tighten the screws 4 to fix the setting 5 Adjusting the dorsal extension plantar flexion position Fig 4 Loosen the two fixation screws 3 e Set the foot plate 2 to an angle that is comfortable for the patient Tighten the screws 3 to fix the angle setting 6 Adjusting the foot rotation position Fig 5 Loosen the fixation screw 21 Set the foot plate 2 to a rotation position that is comfortable for the patient Tighten the screw 21 to fix the setting 15 4 3 Adjusting the Patient Kit 1 Using the Velcro tapes attach the patient 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
17. ltage prior to application of the test level 24 9 2 Electromagnetic immunity Guidance and Manufacturer s Declaration Electromagnetic Immunity ARTROMOT K4 is intended for use in the electromagnetic environment specified below It is the responsibility of the customer or user to ensure that the ARTROMOT K4 device is used in such an environment Immunity test IEC 60601 test Compliance Electromagnetic environment level level guidance Portable and mobile RF communi cations equipment are used no closer to any part of the ARTROMOT K4 device including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Conducted RF to 3 Vis 3 Vms d 12VP IEC 61000 4 6 150 kHz to 80 MHz Radiated RF to IEC 3 V m 8 V m d 1 2 P 61000 4 3 80 MHz to 80 MHz to 800 MHz 2 5 GHz d 12 VP 800 MHz to 2 5 GHz where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey is less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked A with the following symbol NOTE 1 At 80 MHz and 800 MHz the higher freq
18. mage before each use If you detect damage or malfunctions that may impair the safety of the patient or of the operator have the device repaired before using it Technical inspections For safety the devices require regular maintenance To maintain the functional and operational safety check all com ponents for damage and loose connec tions at least once a year These checks should be performed by persons with adequate training and experience Damaged and worn parts must immediately be replaced with original spare parts by authorized staff The device does not require additional regular maintenance Fuse replacement Warning Patient hazard equipment malfunc tion and damage The replacement of fuses must be referred to specialists as defined in IEC 60364 or other applicable stan dards e g biomedical technicians electricians electronics installers Before replacing fuses turn off the ARTROMOT K4 and disconnect the device from the power line Fuses used must be T1A fuses Use an appropriate tool to remove the fuse holder situated between the power switch and the power connector Fig 1 Replace the fuses and reinsert the fuse holder Fig 2 Ensure that the fuse holder properly locks into place Fig 2 6 3 Conversion The ARTROMOT K4 allows the patient s knee and hip pivot to be adjusted once For this purpose the carriage m
19. mitters and the ARTROMOT K4 device as recommended below according to the maximum output power of the communications equip ment rated maximum output separation distance according to frequency of transmitter power of transmitter W m 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz d 12 P d 12vP d 12vP 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 of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 For calculation of the recommended separation distance of transmitters in the frequency range from 80 MHz to 2 5 GHz an additional factor of 10 3 was taken into account to reduce the probability of mobile portable communications equipment brought into the patient environment by accident causing any malfunction NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 10 Contact We would be happy to answer any m Warranty questions you may have about our 2 years mechanical parts products and services 2 years electroncis m ORMED international m Sales Plea
20. ort time 3 You activate the treatment parame ters and functions with the four parameter keys below the display The symbols above the four para meter keys indicate the assigned parameters and functions This is what happens when you press one of the parameter keys to select a parameter 16 e The corresponding symbol appears on the display in a larger format e The set value is displayed e The symbol above the parameter key appears in reverse video 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 Some of the special functions can only be enabled and disabled This is done by pressing the corresponding parameter key or with the keys Active parameters are identified with a check mark in the circle next to the symbol 5 Then press the START key to start therapy If a special function is activated the carriage will first move to the middle position Press the START key again to start therapy Note Refer to section 5 3 for a descrip tion of the parameters e To view the set parameter values press the corresponding parameter key However this is only possible when you press the STOP key first To prevent accidental changes of the parameter settings lock the keys by simultaneously pressing the plus and minus keys by simultaneously pressing the plus and minus keys Pres
21. replacement or reconstruction endoprosthetic implants 1 4 Contraindications Do NOT use ARTROMOT K4 on patients with acute inflammatory processes in the joints unless on the order of a physi cian spastic paralysis unstable osteosynthesis 2 Description of the ARTROMOT K4 The motorized CPM device permits extension and flexion of the knee joint in the range of 10 0 125 and of the hip joint in the range of 0 10 100 It can be used on either side but requires a configuration change These are some of the ARTROMOT K4 features programming unit for precise adjust ment of patient specific therapy values symbols for easy operation of the programming unit physiological movements anatomically correct setup Biocompatibility Those parts of the ARTROMOT K4 device that come into contact with the patient when the device is used as intended are designed to fulfil the biocompatibility requirements of the applicable standards 2 1 Description of the device components Note Please fold out page 3 1 Compartment for storage of programming unit 2 Footplate with patient kit 3 Knobs for ankle adjustment of foot inclination 4 Knobs for length adjustment of lower leg Lower leg patient kit Knee pivot point Thigh patient kit Thigh support Knob for femur length adjustment o vo N o oc H
22. s both keys again to unlock Emergency stop function ARTROMOTP K4 will stop immedia tely 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 e f the carriage is positioned within the programmed range of motion at the time therapy begins the therapy session will start immediately If the carriage is positioned outside the programmed range of motion at the time therapy begins it will first move to the angle setting extension 10 It will stop in this position and you can start the therapy session by pressing the START key m 5 2 Programming ARTROMOT K4 To program the different settings of the ARTROMOT K4 access the respec tive programming level You change between levels by pressing the MENU key repeatedly The display always indicates the currently selected level The following treatment values settings and information can be entered viewed on the programming unit 15 LEVEL 1 Extension han stretching the knee Speed A Warm up protocol bd Flexion A bending the knee LEVEL 2 Extension pause 2 ken Therapy timer O Reverse on load FE feature for patient safety Flexion pause RA LEVEL 3 Transport setting gt 40 New patient 0c Total therapy time 20 Service menu IE Note It is possibe
23. se contact your local dealer Ormed GmbH amp Co KG or the ORMED headquarters in Merzhauser Strasse 112 Germany D 79100 Freiburg Germany m Headquarters Germany Ormed GmbH amp Co KG Merzhauser Strasse 112 D 79100 Freiburg Germany Tel 49 761 45 66 01 Fax 49 761 45 66 55 01 m Internet www ormed de e mail info ormed de 26 11 Technical service 11 1 Technical Hotline 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 11 2 Shipment To prevent damage during transport only use the original shipping box These boxes can be obtained from ORMED or from your local dealer Before packing the CPM device set it to the transport position see chapter 5 11 3 Spare Parts Refer to the Service Manual for the most recent list of spare parts The Service Manual can be obtained from ORMED or from your local dealer When ordering spare parts always specify item Description Part number Qty Serial number of the CPM device Note Refer repairs to authorized specially trained staff 27 DECLARATION OF CONFORMITIY Declaration of conformity In compliance with the Council Directive 93 42 EEC of 14 June 1993 concerning medical devices the company ORMED GmbH amp Co KG Merzhauser Strasse 112 D 79100 Freib
24. splay In this situation you may attempt to restart the device by turning it briefly off and on again with the power switch If the error message persists have the device inspected by a Service techni cian before using it again Caution Equipment damage Connect only the original program ming unit designed for the device in use Any attempt to connect another programming unit to this device may cause damage 4 2 Mechanical Settings Note Before you adjust the ARTROMOT K4 to the patient you may have to convert the device for use on the left or right knee joint see section 6 3 Conversion Performance check If the programming unit can be opera ted as described above and ARTROMOT K4 enters the home position for home position values refer to section 5 3 the device has passed the performance check The device also runs performance checks regularly during operation This is what happens if a problem is identi fied An audio signal sounds The device switches off immediately 14 1 Set the carriage to the home position see 4 1 or to an angle that allows the patient to position the leg on the support without experiencing any pain 2 To begin with set the hip pivot 10 of the carriage to the patient s hip pivot To do so pull on the locking pin 11 of the height adjustment for the carriage hip pivot 10 Then lift the insert for ad
25. sure to prevent chafing and pressure sores Place the leg concerned in a moderate abduc tive position if deemed appropriate 13 Caution Equipment damage Check that the voltage and fre quency ratings of your local power line are those indicated on the nameplate The leg support element withstands a maximum continuous load of 30 kg 66 13 Ib 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 K4 device to direct sunlight because some of the components may reach inadmissibly high temperatures 4 Device setup Note For a better understanding of each step please fold out pages 3 and 34 4 1 Connecting the device performance check 1 Connect the power cord to socket 18 of the device and connect the mains plug to a wall outlet with a non fused earthed wire 100 to 240 Volt 50 60 Hz 2 Connect the programming unit 15 to socket 19 of the device 8 Turn the power switch 16 on 4 Follow these steps to set the carriage to the home position e Press the MENU button on the programming unit until you reach programming level 4 e Press the New Patient parameter key gt 0 twice e Press the START key The CPM device automatically enters the home position The message ERR and an error code e g ERR 5 appear on the di
26. t caught in the moving parts of the device Before cleaning and service inter ventions 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 pro gramming unit If liquids have entered into the devices ARTROMOT K4 must be immedia tely checked by a service techni cian before it can be reused Warning Equipment malfunction 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 radio systems and cell phones are possi ble sources of interference as they may emit higher levels of electroma gnetic radiation Keep the CPM device away from these devices and verify its perfor mance before use Refer repair and maintenance to authorized persons Route all cables below the device frame to either side ensuring that they cannot get caught in the moving parts during operation Inspect ARTROMOT K4 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 Caution Preventing chafing and pressure sores If your patient is adipose very tall or very short be
27. the maximum value is attained Default disabled LEVEL 2 E Extension pause 3 ho Pauses occur at the extension limit just before the bending movement starts Pauses are adjustable in steps of 1 second between 0 and 30 seconds Default no pause 18 Sa Pauses occur at the flexion limit just before the stretching movement starts Pauses are adjustable in steps of 1 second between 0 and 30 seconds Default no pause W Flexion pause Default setting is continuous operation E Therapy timer 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 However the therapy timer can be set in steps of 1 minute to any value between 1 and 300 minutes When the time has elapsed the device switches automatically off and stops in the position set extension value 10 In this case a circle replaces the clock symbol The circle fills as the therapy time progresses E Reverse on load feature amp 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 minimum setting 12 10 kp maximum setting 25 45 kp At 1 10 kp very little resistance will cause the device to reverse at
28. to modify individual treatment parameters or all parame ters together If individual treatment parameters are modified the settings of all other parameters remain unchanged 5 8 Therapy parameter details e You access the different program ming levels by repeated depressions of the MENU key You select the treatment parameters with the corresponding parameter key You change the treatment values with the keys and you enable disable functions by pressing the correspon ding parameter key again You save the settings by pressing the STOP key LEVEL 1 E Extension stretching lo Maximum knee extension 10 degrees Maximum hip extension 10 degrees E Flexion bending Maximum knee flexion 125 degrees Maximum hip flexion 100 degrees Note The programmed value and the value measured at the patient s knee may deviate slightly The most important factor is painless motion of the patient s knee E Speed 7 The speed can be adjusted between 1 0 3 s and 100 3 s in steps of 1 Default 100 nd During warm up the patient will slowly become used to the set maximum extension and flexion values starting from the center position E Warm up protocol The warm up protocol starts in the middle between the two maximum values set for stretching and bending With each cycle the range of motion is increased within 15 cycles
29. uency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is 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 cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the ARTROMOT K4 device is used exceeds the applicable RF compliance level above the ARTROMOT K4 device should be observed to verify normal operation 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 25 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 RF disturbances are controlled The customer or the user of the ARTROMOT K4 device can help prevent electromagnetic interferences by maintaining a minimum distance between portable and mobile RF communications equipment trans
30. urg 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 ll as well as the essential requirements of Annex I With reference to Rule 9 of the Directive 93 42 EEC these products are devices of risk class lla CE 0297 Freiburg January 4 2008 QA Management Representative This certificate is valid through January 4 2010 Annex ARTROMOT S2 PRO ARTROMOT S3 ARTROMOT S3 Comfort ARTROMOT K1 ARTROMOT K2 ARTROMOT K2 PRO ARTROMOT K2 PRO Chip ARTROMOT K3 ARTROMOT K4 ARTROMOT SP2 ARTROMOT SP3 ARTROMOT E2 ARTROMOT E2 compact 28 ES Symbol overview ARTROMOT K4 LEVEL 1 hato A Uj Extensio speed warm up protocol stretching LEVEL 2 pause Extension Therapy Time reverse on load feature for patient safety LEVEL 3 gt A gt 0 transport setting new patient total therapy time 29 Flexion bending RA pause Flexion Il Service Menu Notes 30 Notes 31 Notes 32 Notes 33 Illustrations for device setup Fold out this page 35 MOT 323 01 01 1 08 DIN EN 46 001 ORMED Nr 018 829 01 ORMED GmbH amp Co KG Merzhauser Stra e 112 D 79100 Freiburg Tel 49 761 4566 01 Fax 49 761 4566 5501 www ormed
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