ARTROMOT®-K3 - The Medcom Group, Ltd.
Contents
1. Illustrations for device setup 32 Fold out this page 33 MOT 322 01 01 12 07 ad DIN EN 13485 ORMED Nr 018 829 01 ORMED GmbH amp Co KG s Merzhauser Stra e 112 e D 79100 Freiburg Tel 49 761 4566 01 e Fax 49 761 4566 5501 s www ormed de E Mail info ormed de ORMED IDEAS IN MOTION2. 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 6 2 Maintenance fuse replacement Check before each use Visually inspect the device for signs of mechanical damage 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 functio nal and operational safety check all components for damage and loose connections 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 ori ginal spare parts by authorized staff The device does not require additional regular maintenance Fuse replacement A Warning Patient hazard equipment malfunc tion and damage The replacement of fuses must be re ferred to specialists as defined in IEC 60364 or other applicable standards e g biomedical technicians electri cians electronics installers Before replacing fuses turn off the ARTROMOT K3
3. 4 Contraindications Do NOT use ARTROMOT K3 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 K3 The motorized CPM device permits extension and flexion of the knee joint in the range of 5 0 110 and of the hip joint in the range of 0 8 86 It can be used on either side and re quires no configuration change These are some of the ARTROMOT K3 features programming unit for precise ad justment of patient specific therapy values symbols for easy operation of the programming unit Biocompatibility Those parts of the ARTROMOT K3 device that come into contact with the patient when the device is used as intended are designed to fulfil the biocompatibility requirements of the ap plicable standards 2 1 Description of the device components Note Please fold out page 2 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 Knob for femur length adjustment GO N O 01 Thigh support Thigh patient kit 10 Base 11 Coiled cord 12 Hand held programming unit 13 Power switch ON OFF 14 Fuse cap co 15 Connection for power cord 16
4. 80 dip in U for for 25 cycles 25 cycles lt 5 U gt 95 dip in U for5s lt 5 U gt 95 dip in U for 5 seconds Power fre 3 A m 3 A m Power frequency magnetic fields quency 50 60 should be at levels characteristics of a Hz magnetic typical location in a typical commercial field to IEC or hospital environment 61000 4 8 NOTE UT is the a c mains voltage prior to application of the test level 24 9 2 Electromagnetic immunity Guidance and Manufacturer s Declaration Electromagnetic Immunity ARTROMOT K3 is intended for use in the electromagnetic environment specified below It is the responsibility of the customer or user to ensure that the ARTROMOT K3 device is used in such an environment Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Portable and mobile RF communica tions equipment are used no closer to any part of the ARTROMOT K3 device including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Conducted RF 3 Vrms 3 Vrms d ee 61000 450 kHz to 80MHz Radiated RF to 3 V m 3 V m d 80MHz to 800 MHz IEC 61000 4 3 80 MHz to 2 5 GHz d 800 MHz to 2 5 GHz where P is the maximum output power rating of the transmitter in watts W ac cording to the transmitter manufactur
5. ARTROMOT K3 1 You activate the programming mode by briefly pressing the MENU key on the programming unit 2 The treatment parameters and func tions are allocated to three program ming levels four per level To be able to program a parameter you will have to access the corre sponding 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 short time 3 You activate the treatment parameters and functions with the four parameter keys below the display The symbols above the four parameter keys indicate the assigned parameters and functions This is what happens when you press one of the parameter keys to select a parameter e The corresponding symbol appears on the display in a larger format e The set value is displayed 16 e The symbol above the parameter key appears in reverse video 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 ne
6. deviate slightly E Speed r The speed can be adjusted between 1 and 100 in steps of 1 Default 100 gt l During warm up the patient will slow ly 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 the maximum value is attained Default disabled LEVEL 2 E Extension pause x an Pauses occur at the extension limit just before the bending movement starts Pauses are adjustable in steps of 1 second between 0 and 30 sec onds Default no pause E Flexion pause RA Pauses occur at the flexion limit just before the stretching movement starts Pauses are adjustable in steps of 1 second between 0 and 30 sec onds Default no 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 de vice switches automatically off and stops in the position set extension value 10 18 I
7. ARTROMOT K3 ED Operation Manual Starting with serial number higher than 10000 Fold out this page Device description 17 16 15 14 13 LL uni 11 10 Device description Symbol overview 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 K3 2 1 Description of the device components 2 2 Description of the programming unit 2 4 Explanation of symbols connections and nameplate 3 Safety statements 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 K3 5 2 Programming ARTROMOT K3 5 3 Therapy parameter details 6 Care Maintenance 6 1 Care 6 2 Maintenance fuse replacement 7 Environmental Protection Statement 8 Specifications 9 IEC 60601 1 2 2001 9 2 Electromagnetic immunity 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 12 Declaration of conformity 29 32 O 9 O1 O1 O1 O1 11 14 14 14 15 16 16 17 7 20 20 20 22 22 23 24 25 26 26 27 27 27 27 28 1 How to use the CPM device 1 1 Fields of application ARTROM
8. 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 Relative humidity 20 to 85 Atmospheric pressure 700 hPa to 1060 hPa Ambient conditions operation Ambient temperature 10 C to 40 C 50 to 104 F Relative humidity 30 to 75 Atmospheric pressure 700 hPa to 1060 hPa Subject to change without notice 10 07 9 IEC 60601 1 2 2001 The ARTROMOT K3 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 K3 device The ARTROMOT K3 device should not be used adjacent to or stacked with other equipment If adjacent or stacked use is necessary ARTROMOT K3 should be observed to verify normal operation in the configuration in which it will be used Electromagnetic emissions 9 1 Electromagnetic emissions 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 re quirements after repair Th
9. Connection for programming unit 17 Knob for rotation of footplate 2 2 Description of the programming unit 2 2 1 Programming unit in normal mode set carriage angle selected therapy g g protocol therapy timer set extension value set flexion value selected direction of motion parameter keys MENU key oi key START Key _ key STOP key 2 2 2 Programming unit in MENU selection mode selected MENU level ARTROMOT set carriage angle set extension set flexion value value parameters available for selection corresponding selection keys A 2 2 3 Programming unit in programming mode ARTROMOT selected function set flexion value selected parameter here flexion 2 3 Explanation of symbols Also refer to symbol overview on page 29 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 patient total therapy time service menu 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
10. OT K3 is a motor operated motion device used for Continuous Passive Motion CPM for the knee and hip joints 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 K3 is mainly used to prevent the negative ef fects of immobilization to allow patients to regain painless movement of joints at an early stage and to promote healing and achieve a positive functional 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 1 3 Indications 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 synovecto my arthrolysis or other intra articular interventions mobilization of joints in anesthetized patients operative treatment of fractures pseudarthrosis and corrective oste otomy cruciate ligament replacement or reconstruction endoprosthetic implants 1
11. TE 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 Warranty questions you may have about our 2 years mechanical parts products and services 2 years electronics E Ormed international Sales Please contact your local dealer Ormed GmbH amp Co KG or the ORMED headquarters in Merzhauser Strasse 112 Germany D 79100 Freiburg Germany E 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 E Website 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 The se 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 Descrip
12. a problem is identified An audio signal sounds The device switches off immediately The message ERR and an error code e g ERR 5 appear on the display In this situation you may attempt to restart the device by turning it briefly 14 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 A 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 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 sup port without experiencing any pain 2 Adapting the carriage to the femur length Fig 2 e Loosen the two fixation screws 7 e Adjust the appropriate femur length 8 e Tighten the screws 7 to fix the setting A Caution Equipment damage Please do not try to pull out the femur length adjustment past the stop 3 Adapting the carriage to the tibia length Fig 3 e Loosen the two fixation screws 4 e Adjust the appropriate tibia length The setting should exactly match the length of the patient s lower leg e Tighten the screws 4 to fix the setting 4 Adjusting the dorsal extension plan tar flexion posi
13. 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 1 Fig 2 21 7 Environmental Pro tection 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 possib le recycling of the product 8 Specifications Input ratings 100 240 V AC 50 60 Hz Current consumption 850 370 mA Fuses 2xTiA slow blow Protection class IP degree of protection IPXO Applied part type B Max load on carriage 30 kg 66 13 Ib Physical Length 93 cm 36 61 In Width 35 cm 13 78 In Height 43 cm 16 93 in Adjustment ranges min max femur range approx 36 46 cm 14 17 18 11 In lower leg range approx 42 5 56 cm Weight Materials used 16 73 22 04 In 11 8 kg 26 01 Ib 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
14. communications equipment and the ARTROMOT K3 device The ARTROMOT K3 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the ARTROMOT K3 device can help prevent electromagnetic interferences by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the ARTROMOT K3 device as recommended below according to the maximum output power of the communications equipment rated maximum output separation distance according to frequency of transmitter power of transmitter m W 150 kHz to 80 MHZ 80 MHz to 800 MHZ 800 MHz to 2 5 GHz d 127 P d 1 2 P d 1 2 P 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 separation 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 NO
15. er and dis the recommended separation distance in meters m Field strengths from fixed RF transmit ters as determined by an electromag netic site survey a is less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol U kad 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 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 K3 device is used exceeds the applicable RF compliance level above the ARTROMOT K3 device should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the ARTROMOT K3 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
16. he moving parts of the CPM device 12 Z Warning Shock hazard Strictly observe the following warn ings Failure to do so endangers the lives of the patient the user and other persons involved Before use allow the ARTROMOT K3 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 K3 device must only be operated in dry rooms When disconnecting the device from the power line remove the plug from the wall outlet first be fore 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 K3 must be con nected to a properly installed wall outlet with a non fused earthed wire Before connecting the power cord it must be completely unrolled and placed such that it will not get caught in the moving parts of the device 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 en ter the CPM device or the prog
17. is requirement 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 Guidance and Manufacturer s Declaration Electromagnetic Emissions such an environment ARTROMOT KS is intended for use in the electromagnetic environment specified below It is the responsibility of the customer or user to ensure that the ARTROMOT K3 device is used in Emissions test Compliance Electromagnetic environment guidance RF emissions to CISPR 11 Group 1 ARTROMOT K3 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 K3 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 61000 3 2 Harmonic emissions to IEC not applicable emissions to IEC 61000 3 3 Voltage fluctuations flicker not applicable 23 9 2 Electromagnetic immunity Guidance and Manufacturer s Declaration Electromagnetic Immunity ARTROMOT K3 is intended for use in the electromagnetic environment specified below It is the responsibility of the customer or user to ensure that the ARTROMOT K3 de
18. l power line are those indicated on the nameplate The leg support element with stands 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 K3 device to direct sunlight because some of the components may reach inadmis sibly high temperatures 4 Device setup Note For a better understanding of each step please fold out pages 3 and 32 4 1 Connecting the device performance check 1 Connect the power cord to socket 15 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 12 to socket 16 of the device 3 Turn the power switch 13 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 3 e Press the New Patient parameter key 204 e Press the START key The CPM de vice automatically enters the home position Performance check If the programming unit can be operated as described above and ARTROMOT K3 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
19. leted The new patient function home po sition selects the following settings extension 25 flexion 35 speed 100 warm up disabled extension pause 0 flexion pause 0 timer continuous operation reverse onload 45 kp total therapy time 0 E Total therapy time gt The total therapy time is the added sum of operating hours If the device is used by only one patient this time is equivalent to the duration of all the patient s therapy sessions Deleting the stored therapy time Press and hold the parameter key for 5 seconds or select the New Patient function E Service menu ul For service purposes only refer to Service Manual Reminder You save the selected parameter values by pressing the STOP key 19 6 Care Maintenance 6 1 Care A 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 e ARTROMOT K3 can be disinfected by wiping down with a disinfectant Thus it complies with the special hy giene standards for medical technical equipment e The enclosure can be cleaned with common disinfectants and mild household cleaning agents e Only use a damp cloth to wipe the CPM device down A Caution Equipment damage The plastic material used is not resistant to mineral acids
20. n this case a circle replaces the clock symbol The circle fills as the therapy time progresses E Reverse on load feature for patient safety aS The device automatically starts mov ing in the opposite direction of the last movement when the patient s re sistance load exceeds the set value Adjustable levels for reverse on load feature 1 25 minimum setting 1 25 kp maximum setting 25 45 kp At 1 25 kp very little resistance will cause the device to reverse at 25 45 kp a high resistance is required to initiate the reversal Default 45 kp Note e These values are approximate values e The force needed is measured at the frame around the foot A 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 E Transport setting 01 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 trans port position E New patient gt 0 With this function the CPM device will move to the home position al lowing 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 de
21. of product with unsorted household or municipal waste 10 3 Safety statements Definitions It is mandatory to read the safety state ments before use of the CPM device The safety statements 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 A Caution This term indicates a potential haz ard If not avoided this hazard can result in minor personal injury and or product property damage Safety information A Danger Explosion hazard ARTROMOT K3 is not designed for use in areas where an explosion haz ard may occur An explosion hazard may result from the use of flammable anesthetics skin cleansing agents and disinfectants 11 A Warning Patient hazard Only authorized individuals are al lowed to operate the ARTROMOT K3 device Individu als are authorized after receiving training in the operation of the device and reading this operation manual Before using the device the opera tor must ascertain that it is in cor rect working order and operating condition In particular the cables and connectors must be checked for signs of damage Damaged parts must be replaced immedi ately before use Before
22. ram ming unit If liquids have entered into the devices ARTROMOT K3 must be immediately checked by a service technician before it can be reused A 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 require ments X ray equipment MRI devices radio systems and cell phones are possible sources of in terference as they may emit higher levels of electromagnetic 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 de vice frame to either side ensuring that they cannot get caught in the moving parts during operation Inspect ARTROMOT K3 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 13 A Caution Preventing chafing and pressure sores If your patient is adipose very tall or very short be sure to prevent chafing and pressure sores Place the leg concerned in a mode rate abductive position if deemed appropriate A Caution Equipment damage Check that the voltage and fre quency ratings of your loca
23. s the cur rently selected level The following treatment values set tings and information can be entered viewed on the programming unit 12 LEVEL 1 Extension stretching the knee Speed MR Warm up protocol Li Fexion bending the knee LEVEL 2 Extension pause x ken Therapy timer Reverse on load zs feature for patient safety Flexion pause ZA ED 5 2 Programming ARTROMOT K3 17 LEVEL 3 Transport setting gt New patient gt 0 Total therapy time gt Service menu JC Note It is possibe to modify individual treatment parameters or all parame ters together If individual treatment parameters are modified the settings of all other parameters remain un changed 5 3 Therapy parameter details You access the different programming 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 correspond ing parameter key again You save the settings by pressing the STOP key LEVEL 1 E Extension stretching E Flexion bending kun Maximum knee extension 5 degrees Maximum hip extension 8 degrees A Maximum knee flexion 110 degrees Maximum hip flexion 86 degrees Note The programmed value and the value measured at the patient s knee may
24. therapy a test run con sisting of several exercise cycles must be completed first without and then with the patient Check that all setting screws are tight ened Stop therapy immediately when you have doubts about the device settings and or the therapy proto col 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 parameters to program and of the therapy protocols to use is restricted to the responsible physician or therapist It is the physician s or therapist s decision whether or not to use the CPM device on a specific patient The patient must be familiar with the functions of the ARTROMOT K3 programming unit and the unit must be within easy reach of the patient allowing him or her to stop therapy if needed Patients un able to operate the programming unit e g paralytic patients must never be left unattended during therapy All accessories used with the ARTROMOT K3 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 t
25. tion Part number Qty Serial number of the CPM device Note Refer repairs to authorized specially trained staff 27 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 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 Il 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 p Fi i x i F r F Freiburg 22 10 07 lt gt fone be QA Management Representative This certificate is valid through 22 October 2010 Annex ARTROMOT S2PRO ARTROMOT S3 ARTROMOT S3 Comfort ARTROMOT K1 ARTROMOT K2 ARTROMOT K2PRO ARTROMOT K2PRO Chip ARTROMOT K3 ARTROMOT K4 ARTROMOT SP2 ARTROMOT SP3 ARTROMOT E2 ARTROMOT E2compact 28 Symbol overview LEVEL 1 best Mr gt l S N Extension speed warm up protocol Flexion bending stretching LEVEL 2 A TMA pause Extension Therapy Time reverse on load pause Flexion feature for patient safety LEVEL 3 gt 0 2 gt transport setting new patient total therapy time Service Menu 29 Notes 30 Notes 31
26. tion Fig 4 e Loosen the two fixation screws 3 e Set the foot plate 2 to an angle that is comfortable for the patient e Tighten the screws 8 to fix the angle setting 5 Adjusting the foot rotation position Fig 5 e Loosen the fixation screw 17 e Set the foot plate 2 to a rotation position that is comfortable for the patient e Tighten the screw 17 to fix the setting 4 3 Adjusting the Patient Kit 1 Using the Velcro tapes attach the pa tient kits for lower leg 5 and thigh 9 to the frame of the motion element Fig 6 an Fig 7 2 Now position the patient s leg 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 A 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 15 5 Setting the treatment values A 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
27. vice is used in such an environment Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Electrostatic 6 kV contact 6 kV contact Floors should be wood concrete or discharge ceramic tile If floors are covered with ESD to IEC synthetic material the relative humidity 61000 4 2 8 kV air 8 kV air should be at least 30 Electrical fast 2 KV for power 2 KV for power Mains power should be that of a typical transient burst supply lines supply lines commercial or hospital environment no 61000 4 KV for 1 KV for input output lines input output lines Surges to IEC 61000 4 5 Voltage dips short inter ruptions and voltage varia 1 kV differential mode 2 kV common mode lt 5 U gt 95 dip in U for Y2 cycle 1 kV differential mode 2 kV common mode lt 5 U gt 95 dip in U for cycle Mains power should be that of a typical commercial or hospital environment Mains power should be that of a typical commercial or hospital environment If the user of the ARTROMOT K device requires continued operation during tions on power 40 U o inU power mains interruptions it is recom supply input 60 dip in U f r ae CO T mended that the ARTROMOT K3 lines to IEC for 5 cycles y device be powered from an uninterrup 61000 4 11 70 U tible power supply or a battery 10 U 30 dip in U p in U
28. xt to the symbol 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 e Refer to section 5 3 for a descripti on 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 e To prevent accidental changes of the parameter settings lock the keys by simultaneously pressing the plus and minus keys Press both keys again to unlock 8 e Emergency stop function ARTROMOT K3 will stop im mediately when any of the keys is pressed during therapy Patient treatment can be resumed by pressing the START key The de vice will automatically change the direction e If the carriage is positioned within the programmed range of motion at the time therapy begins the therapy session will start immedi ately e 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 To program the different settings of the ARTROMOT K3 access the respec tive programming level You change between levels by pressing the MENU key repeatedly The display always indicate
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