ARTROMOT®-K1 classic
Contents
1. item description part number quantity serial number of the CPM device Note Refer repairs to authorized specially trained staff ORMED GmbH amp Co KG offers service training for your personnel Surcharges may apply in certain cases to spare parts ordered in low quantities 48 Declaration of conformity In compliance with the Council Directive 93 42 EEC of 14 June 1993 concerning medical devices the company English ORMED GmbH amp Co KG Merzhauser StraBe 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 Il as well as the essential requirements of Annex l CE 0297 Freiburg August 28 2006 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 E2 ARTROMOT E2 compact 49 QA Management Representative ARTROMOT K1 classic setup illustrations ORMED 806 AHG L g DIN EN 13485 ORMED Nr 018 829 01 ORMED GmbH amp Co KG e Merzhauser Stra e 112 e D 79100 Freiburg Tel 49 761 4566 01 e Fax 49 761 4566 5501 e www ormed de E Mail info ormed de ORMED IDEEN BEWEGEN2. If 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 starts it will first enter the position extension 10 The carriage will stop in this position and you can initiate the therapy session by pressing the START STOP key again Note The programmed value and the value measured at the patient s knee may deviate slightly 5 2 Information about the ARTROMOT K1 classic therapy parameters You select a function by pressing the corresponding control You change the treatment values by turning the depressed control You initiate the treatment session by pressing the START STOP key E Extension streching beu Maximum knee extension 10 degrees Maximum hip extension 7 degrees E Flexion bending TaN Maximum knee flexion 120 degrees Maximum hip flexion 115 degrees E Speed a YA The speed can be adjusted between 5 and 100 in steps of 5 Default setting 50 E Pauses x Pauses occur at the selected limits where stretching turns into bending and bending into stretching selected extension and flexion values The value entered applies to both extension and flexion pause Pauses can be set to any value bet ween 0 and 59 seconds in steps of 1 second
3. Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Electrostatic discharge ESD to IEC 61000 4 2 6 kV contact 6 kV contact 8 kV air 6 kV contact 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 30 Electrical fast transi ent burst to IEC 61000 4 5 2 kV for power supply lines 2 kV for power supply lines 1 kV for input output lines 2 kV for power supply lines 1 kV for input out put lines Mains power should be that of a typical commercial or hospital environment Surges to IEC 61000 4 5 1 kV differential mode 2 kV common mode 1 kV differential mode 2 kV common mode Mains power should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines to IEC 61000 4 11 lt 5 Ur 95 dip in Ur for 1 2 cycle 40 Ur 60 dip in Ur for 5 cycle 70 Ur 80 dip in Ur for 25 cycles lt 5 UT gt 95 dip in Ur for 5s lt 5 UT gt 95 dip in Ur for 4 cycle 40 Ur 60 dip in Ur for 5 cycle 70 Ur 80 dip in Ur for 25 cycles lt 5 UT gt 95 dip in Ur for 5s Mains power should be that of a typical commercial or hospital environment If the user of the ARTROMOT K1 classic
4. 9 3 Recommended separation distances between portable and mobile RF communications equipment and the ARTROMOT K1 classic device The ARTROMOT K1 classic is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the ARTROMOT K1 classic device can help prevent electromagnetic interferences by maintaining 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 output power of DU separation distance according to frequency of transmitter m 150 kHz to 80 MHz d 12VP 800 MHz to 2 5 GHz d 2 3YP 80 MHz to 800 MHz d 1L2VP 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 03 100 12 12 e 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 mobil
5. ARTROMOT K1 classic D Operation Manual Device description 89 10 11 12 13 fil 7 448 9 1817 16 Contents ARTROMOT K1 classic description ARTROMOT K1 classic setup illustrations 1 10 11 12 How to use the CPM device 1 1 Fields of application 1 2 Therapy objectives 1 3 Indications 1 4 Contraindications ARTROMOT K1 classic description 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 Safety information Device setup 4 1 Connecting the device performance check 4 2 Adjusting the device to the femur length 4 3 Adapting the leg support assemblies footplate Setting the treatment values 5 1 General information on programming ARTROMOT K1 classic 5 2 Information about the ARTROMOT K1 classic therapy parameters Care maintenance transport 6 1 Care 6 2 Maintenance fuse replacement 6 3 Transport Environmental Protection Statement Specifications IEC 60601 1 2 2001 9 1 Electromagnetic emissions 9 2 Electromagnetic immunity 9 3 Recommended Separation Distances How to reach us Technical service 11 1 Technical hotline 11 2 Shipment 11 3 Spare parts Declaration of conformity 28 150 29 29 29 29 29 30 30 31 33 34 35 38 38 38 39 40 40 42 42 42 43 43 43 44 44 45 47 47 48 48
6. approx 31 49 cm approx 25 57 cm 11 kg ABS POM Delrin 100 PUR PA FR4 aluminium stainless steel brass class 2a Standards compliance Certification IEC 60601 1 1988 A1 1991 A2 1995 ANSI UL 60601 1 CAN CSA C22 2 No 601 1 English EMC electromagnetic compatibility IEC 60601 1 2 2001 Ambient conditions storage transport temperature 24 C to 60 C 12 F to 140 F relative humidity 20 to 85 atmospheric pressure 700 hPa to 1060 hPa Ambient conditions operation temperature 10 C to 40 C 50 F to 104 F relative humidity 30 to 75 atmospheric pressure 700 hPa to 1060 hPa Subject to change without notice 08 06 9 IEC 60601 1 2 2001 The ARTROMOT K1 classic device is subject to particular precautions regar ding 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 K1 classic device ARTROMOT K1 classic should not be used adjacent to or stacked with other equipment If adjacent or stacked use is necessary ARTROMOT K1 classic should be observed to verify normal operation in the configuration in which it will be used We can guarantee the specified electro magnetic emission and immunity data only if the manu
7. device requires continued operation during power mains interruptions it is recommended that the ARTROMOT K1 classic device be powered from an uninterruptible power supp ly 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 characteristics of a typical location in a typical commercial or hospital environment Portable and mobile RF communications equipment are used no closer to any part of the ARTROMOT K1 classic device including cables than the recommended separation distance calcula ted from the equation appli cable to the frequency of the transmitter NOTE U is the a c mains voltage prior to application of the test level 45 English Guidance and Manufacturer s Declaration Electromagnetic Immunity ARTROMOT K1 classic is intended for use in the electromagnetic environment specified below It is the responsibility of the customer or user to ensure that the ARTROMOT K1 classic device is used in such an environment Immunity test IEC 60601 Compliance level Electromagnetic environ test level ment guidance Recommended separation distance Conducted RF to 3 Vms 3 Vms IEC 61000 4 6 150 kHz to d 12YP 80 MHz Radiated RF to 3 V m 3 V m d 1272 80 MHz to IEC 61000 4 3 80 MHz to 800 MHz 2 5 GHZ d 2312 800 MHz to 2 5 GHZ where P is the maximum o
8. sores When your patient is adipose very tall or very short be sure to prevent chafing and pressure sores Place the leg concerned in a moderate abduction position if deemed appropriate 37 CAUTION Equipment damage Check that the voltage and frequency ratings of your local power line are those indicated on the nameplate The leg support element with stands a maximum continuous load of 20 kg Do not allow any objects such as blankets cushions or cables to get caught in the moving parts of the CPM device Do not expose the ARTROMOT K1 classic device to direct sunlight because some of the components may reach inadmissibly high temperatures English 4 Device setup Note For a better understanding of each step please fold out pages 3 and 150 4 1 Connecting the device performance check 1 Connect the power cord to socket 15 of the device and mains plug to a wall outlet with a non fused earthed wire 100 to 240 Volt 50 60 Hz 2 Turn the power switch 17 on 3 Follow these steps to set the carriage to the home position Press the Extension key D and holding it depressed rotate until 30 appears in the display above the control In the same manner select a Flexion value of 35 A Then press the START STOP key When the carriage has reached this range and does not stop automati cally
9. press the START STOP key again to stop any movement Note ARTROMOT K1 classic will stop automatically in the home position range only if it was positioned outside this range 30 to 35 at the time of programming also refer to 5 2 Performance check If the programming unit can be operated as described above and 38 ARTROMOT K1 classic enters the home position for home position values refer to section 4 1 the device has passed the performance check The device also runs performance checks regularly during operation This is 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 to restart the device by turning the device briefly off and on again with the power switch If the error message persists have the device inspected by a Service technician before using it again 4 2 Adjusting the device to the femur length 1 Measure the length of the patient s thigh femur from the greater trochanter to the lateral Knee joint cavity Fig A 2 Set the carriage to the home position see 4 1 3 Set the measured value at the femur scale 3 of the carriage Loosen the two fixation screws 4 Extend the scale 8 to the required length Tighten the fixation screws 4 to set
10. 48 48 49 1 How to use the CPM device 1 1 Fields of application ARTROMOT K1 classic is a motor operated Continuous Passive Motion CPM device used to mobilize 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 K1 classic is mainly used to prevent the negative effects of immobilization to allow patients to regain painless mobility of joints at an early stage and to promote healing and achieve a positive functional result Other objectives of therapy include improvement of joint metabolism prevention of joint stiffness promotion of the regeneration and healing of cartilage and damaged ligaments faster hematoma fluid resorption improved lymph and blood circulation thrombosis and embolism prophylaxis 1 3 Indications The CPM device is indicated in the treat ment 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 procedures in combination with synovectomy arthrolysis or other intra articular interventions mobilization of joints in anesthetized patients operative treatment of fractures pseudoarthrosis and os
11. after receiving training in the operation of the device and reading this operation manual Before using the device the operator must ascertain that it is in correct working order and operating condition In particular the cables and connectors must be checked for signs of damage Damaged parts must be replaced immediately with original spare parts Before therapy a test run consisting of several exercise cycles must be completed first without and then with the patient Check that all fixation screws are tightened Stop therapy immediately when you have doubts about the device settings and or the therapy protocol English WARNING Patient hazard It is important that the patient s position is anatomically correct Therefore carefully verify the following settings positions 1 femur length 2 knee joint axis 3 tibia length and leg rotation 4 leg support assemblies Movements must not cause pain or irritation Patients must be fully conscious while being instructed in the use of the CPM device and during therapy Only the responsible physician or therapist is able and allowed to choose the therapy parameters to use 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 K1 classic programming unit and the unit must be within easy reach of the patien
12. and to values between 1 and 59 minutes in steps of 1 minute When selecting the seconds the value changes in 1 second steps for the first five seconds Subsequently the interval changes to 5 second steps The minutes are always adjusted in 1 minute steps Default setting no pause English 6 Care maintenance transport 6 1 Care WARNING Shock hazard Unplug the device from the power line before cleaning Shock hazard equipment damage Liquids must not enter the device or the programming unit ARTROMOT K1 classic can be disinfected by wiping down with a disinfectant Thus it complies with the special hygiene standards for medical technical equipment The enclosure and removable leg support assemblies can be cleaned with commonly used disinfectants and mild household detergents Use only a damp cloth to wipe the carriage down Clean the sheath of the programming unit on a regular basis Remove it from the programming unit before cleaning Allow the sheath to dry before inserting the programming unit again CAUTION Equipment damage The plastic material used is not resistant to mineral acids formic acid phenols cresols oxidizing agents 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 sunli
13. can be changed by turning the depressed control When you have set the new value release the control and the standard display reappears automatically after approx 5 seconds see also 2 2 1 Subsequently press the START STOP key to start therapy 1 You activate a function by briefly pressing a control on the programming unit 2 You select a treatment value by pressing the respective control and turning it in either direction You increase a value by turning the control clockwise towards the plus symbol and you decrease a value 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 the interval changes to 5 so that you reach the target value faster During adjustment of the extension and flexion angles the values in the display change as you turn the con trol after pressing it Note Refer to sections 5 2 for a description of the parameters To prevent accidental changes of the parameter settings lock the programming unit by simulta neously pressing the Extension and Speed controls Press both controls again to unlock Emergency stop function ARTROMOT K1 classic will stop immediately when any of the keys is pressed during therapy Patient treatment can be resumed by pressing the START STOP key The device will automatically change the direction
14. e leg support assemblies with disposable tissues when using ARTROMOT K1 classic immediately after surgery This helps prevent discoloration Patient hazard CAUTION Ensure that the rotational axes of the CPM device and of the knee joint coincide both in the vertical and in the horizontal plane Fig G Symbol 1 Measurement of the patient s femur length from the greater trochanter to the Knee joint cavity Symbol 2 Set the carriage to the home position see 4 1 and adjust it to the measured femur length Symbol 3 Adjust height of calf and thigh support assemblies Adjust the footplate to the height and length of the lower leg English 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 150 5 1 General information on programming ARTROMOT K1 classic When adjusting speed or pause the information shown in the display changes automatically as you press the control The selected parameter Speed or pause is immediately represented by its symbol in a large format plus the current value also refer to 2 2 2 The current value
15. e 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 How to reach us We would be happy to answer any questions you may have about our products or services R ORMED international Please contact your local dealer or the ORMED headquarters in Germany E Headquarters Germany ORMED GmbH amp Co KG Merzhauser StraBe 112 79100 Freiburg Germany Tel 49 761 45 66 01 Fax 49 761 45 66 55 01 E Internet www ormed de e mail info ormed de 47 Warranty 2 years mechanical parts 2 years electronics Sales ORMED GmbH amp Co KG Merzhauser StraBe 112 D 79100 Freiburg English 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 Before packing the CPM device set it to the transport position See chapter 6 3 11 3 Spare parts Refer to the Service Manual for the most recent list of spare parts When ordering spare parts always specify
16. ecting the power cord it must be com pletely unrolled and placed such that it will not get caught by 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 programming unit If liquids have entered into the devices ARTROMOT K1 classic 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 and radio systems are possible sources of interference as they may emit higher levels of electromagnetic radiation Keep the CPM device away from these devices and verify its performance before use Refer repair and maintenance to authorized persons Route all cables below the device frame to either side ensuring that they cannot get caught by the moving parts during operati on Inspect ARTROMOT K1 classic 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
17. facturer s original spare parts are used in repair and maintenance of the device 9 1 Electromagnetic emissions Guidance and Manufacturer s Declaration Electromagnetic Emissions Emissions test Compliance ARTROMOT K1 classic is intended for use in the electromagnetic environment specified below It is the responsibility of the customer or user to ensure that the ARTROMOT K1 classic device is used in such an environment Electromagnetic environment guidance CISPR 11 RF emissions to Group 1 ARTROMOT K1 classic uses RF energy CISPR 11 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 Class B ARTROMOT K1 classic 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 61000 3 2 not applicable Voltage fluctuations flicker emis sions to IEC 61000 3 3 not applicable 44 9 2 Electromagnetic immunity Guidance and Manufacturer s Declaration Electromagnetic Immunity ARTROMOT K1 classic is intended for use in the electromagnetic environment specified below It is the responsibility of the customer or user to ensure that the ARTROMOT K1 classic device is used in such an environment
18. ght and fire 42 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 functional 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 Original spare parts by authorized staff The checks can be carried out by ORMED within the framework of a service agreement Contact ORMED for details The device does not require additional regular maintenance Fuse replacement A WARNING Patient hazard equipment malfunction and damage The replacement of fuses must be referred to specialists as defined in IEC 60364 or similar standards e g biomedical technicians electricians electronics installers Fuses used must be T1A fuses 6 3 Transport Follow these steps to prepare the ARTROMOT K1 classic for transport 1 Adjust the femur length to 49 cm and the tibia length to 45 cm 2 Set the carriage to 0 by pressing the START STOP key whe
19. height of the calf support assembly 8 Calf length fixation screws tibia length 9 Calf length scale tibia length scale 10 Strap to secure the foot to the footplate 11 Footplate 12 Footplate angle fixation screw 13 Clamping lever to adjust footplate rotation and level and to remove the footplate 14 Connection for programming unit 15 Connection for power cord 16 Fuse cap 17 Power switch ON OFF 18 Nameplate 19 Programming unit 2 2 Description of the programming unit 2 2 1 Programming unit in normal mode A RTRO M OT G selected angle of the CPM device set extension t flexion val val set flexion value selected direction of motion Extension control Flexion control Speed control Pause control START STOP key during operation LED green when stopped LED yellow 31 English 2 2 2 Programming unit in speed or pause programming mode ARTROMOT set value of selected function here speed selected function 32 2 3 Explanation of symbols Symbols on the programming unit Symbols that may appear in the display Extension Go to start position stretching the knee see Notes in 4 1 Flexion Controls on bending the knee programming unit locked Speed see Notes in 5 1 Controls on Pause extension l programming unit and flexion unlocked see Notes in 5 1 Service men
20. n the Carriage is in the 0 position This will stop the carriage in that position 3 Push the power switch to turn off the ARTROMOT K1 classic 4 Disconnect the power cord and the programming unit 5 The device must be stored in its original shipping box for transport ORMED GmbH amp Co KG cannot be held liable for damage in transit if the original shipping box was not used 6 Inser the programming unit into the space provided in the molded polystyrene pads and secure with adhesive tape 7 Set the footplate to a horizontal position 8 Now slide the polystyrene pads onto the ARTROMOT K1classic 9 Place the power cord at the bottom of the box before inserting the ARTROMOT K1 classic including the polystyrene pads Power Cord Programming Unit 43 7 Environmental protection statement The product described in this operation manual must not be dispose of with unsorted household or municipal waste It requires separate disposal Please contact ORMED for information about the possible recycling of the product 8 Specifications Input ratings 100 240 V AC 50 60 Hz Current consumption 850 370 mA Fuses 2 x T1A Protection class Applied part type B Max load on carriage 20 kg Dimensions length 96 cm width 35 cm height min 23 cm to max 56 cm Adjustment ranges min max Femur range Lower leg range Weight Materials used MDD
21. t allowing him or her to stop therapy if needed Patients unable to operate the program ming unit e g paralytic patients must never be left unattended during therapy Any accessories used with ARTROMOT K1 classic must first be approved by ORMED Do not allow parts of the body or objects such as blankets cushions or cables to get caught in the moving parts of the CPM device 36 WARNING Shock hazard Strictly observe the following warnings Failure to do so endangers the lives of the patient the user and other persons involved Allow ARTROMOT K1 classic to reach room temperature before use If the device has been trans ported at temperatures below 0 C 30 F leave it to dry at room temperature for about 2 hours until any condensation has disappeared The ARTROMOT K1 classic 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 K1 classic must be connected to a properly installed wall outlet with a non fused earthed wire Before conn
22. teotomy cruciate ligament replacement or reconstruction endoprosthetic implant 1 4 Contraindications Do NOT use ARTROMOT K1 classic on patients with acute inflammatory processes in the joints unless on the order of a physician spastic paralysis unstable osteosynthesis English 2 ARTROMOT K1 classic description The motorized CPM device permits extension and flexion of the knee joint in the range of 10 0 120 and of the hip joint in the range of 0 7 115 It can be used on either side and requires no configuration change These are some of the outstanding ARTROMOT K1 classic features anatomically correct setup physiological movements programming unit for precise adjustment of patient specific therapy parameters symbols for easy operation of the programming unit Biocompatibility The parts of the ARTROMOT K1 classic device that come in contact with the patient during the intended use are designed to fulfill the biocompatibility requirements of the applicable standards 2 1 Description of the device components Note Please fold out page 3 1 Thigh support assembly 2 Clamping lever to adjust the height of the thigh support assembly 3 Thigh length scale femur length scale 4 Thigh length fixation screws femur length 5 Knee hinge 6 Calf support assembly 30 7 Clamping lever to adjust the
23. the scale to the new length CAUTION Equipment damage Do not attempt to extend the femur scale beyond the stop 4 3 Adapting the leg support assem blies footplate 1 Set the leg support assemblies and the footplate 1 6 11 to the expected positions before accommodating the patient Loosen fixation screws 8 to adjust the footplate 11 to the length of the patient s lower leg Fig C Loosen clamping lever 13 and adapt the footplate s rotation and height to the patient Fig D Loosen fixation screw 12 and adapt the angle to the patient s foot turn the screw a few revolutions until the footplate can be easily adjusted For short patients you can reverse the footplate s bracket 180 Fig H to adapt the footplate to shorter Calves e Loosen clamping lever 13 and remove the footplate 11 e Loosen the fixation screws 12 e Reverse the bracket 180 e Screw the footplate to the bracket and tighten the clamping lever Note When reversing the footplate ensure that the pins below the clamping lever engage with the recesses in the bracket To adjust the height of the support assemblies for calf 1 and thigh 6 loosen clamping levers 2 and 7 Figs E F 2 Place the patient s leg on the carria ge and repeat the steps outlined under 1 above to adjust the device to the patient 39 CAUTION Equipment damage Cover th
24. u activated for service purposes only also refer to Service Manual 33 English 2 4 Explanation of symbols connections and nameplate Alternating current Protective earth connection Type B applied part Power switch OFF Power switch ON 0 gt Refer to accompanying documents Do not dispose product ZA with unsorted house hold or municipal waste gt 34 3 Safety information Introduction and definitions Read the safety statements before use of the CPM device The safety state ments are classified as follows DANGER Indicates an imminent hazard If not avoided this hazard will result in death or serious injury WARNING 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 product property damage 35 Safety information DANGER Explosion hazard ARTROMOT K1 classic is not designed for use in areas where an explosion hazard may occur An explosion hazard may result from the use of flammable anesthe tics skin cleansing agents and disinfectants Z WARNING Patient hazard Only authorized individuals are allowed to operate the ARTROMOT K1 classic device Individuals are authorized
25. utput power rating of the transmitter in watts W according to the transmitter manufacturer and 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 with the following symbol WN 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 mea sured field strength in the location in which the ARTROMOT K1 classic device is used exceeds the applicable RF compliance level above the ARTROMOT K1 classic 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 K1 classic device b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m 46
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