ARTROMOT K3 Gebr Innen
Contents
1. ORMED G04 DIN EN 13485 ORMED Nr 018 829 01 ORMED GmbH amp Co KG 7 Merzhauser Stra e 112 7 D 79100 Freiburg Phone 49 761 4566 01 7 Fax 49 761 4566 5501 www ormed de 7 E Mail info ormed de St Paul U SA Phone 1 800 4402784 Fax 1 651 4157405 7 Prague CR Phone 420 2 84094650 Fax 420 2 84094660 e Vienna A Tel 43 1 53 20 83 40 Fax 43 1 53 20 83 431 ORMED Play ee2. checks at short intervals for possible damage and loose connections Damaged or worn parts should be replaced immediately with original spare parts by an authorized specialist To avoid transport damages use only the original packing boxes These boxes can be ordered from Ormed Before carrying the device always make sure the femur length adjustment is locked Maintenance Not necessary Guarantee 2 years warranty on mechanical and electronical parts Manufacturer ORMED GmbH amp Co KG Merzhauser Strafe 112 D 79100 Freiburg Germanv DECLARATION OF CONFORMITY Declaration of Conformity According to the EC Regulation for medical devices the EC Medical Devices Directive MDD 93 42 EEC dated 14th J une 1993 appendix 2 The Manufacturer ORMED GmbH amp Co KG Merzhauser Strafe 112 D 79100 Freiburg herewith declares that the following units Tvpe Knee amp Hip Name ARTROMOT K3 meets all requirements of following EC directives EN 60 601 1 1990 Electrical Medical Devices Part 1 Basic Rules for Safety EN 60 601 2 1993 Electrical Medical Devices Part 1 and 2 additional norm electromagnetic compatibility requirements and testing The adherence to the standard specifications entitles to marking of these devices with CE 0297 0297 Freiburg J anuary 20 2002 Cab enee Quality Control Manager 12
3. 2 Description of the ARTROMOT K3 The ARTROMOT K3 CPM device allows extension and flexion of the knee joint in the range of 5 0 110 degrees There is no need to convert the device when switching from the right to left side or vice versa The ARTROMOT K3 features a hand held programming unit that can be used to program and store any treatment values Explanation of symbols Explanation of functioning elements Alternating current Protective system Type B O 230 Power off Power on Device off Device on Oe Note Fold out page 1 1 Knob for femur length adjustment 2 Base 3 Coiled cord 4 Controller cable 5 Hand held programming unit 6 Knob for length adjustment of lower leg 7 Power adapter 8 Main switch 9 Knob for angle adjustment of foot inclination 10 Foot plate with patient kit 11 Socket for power adapter 12 Knob for rotation footplate 13 Kit straps 14 Lower leg patient kit 15 Knee pivot point 16 Thigh patient kit 3 Safety instructions N CAUTION these instructions must be read before start up The ARTROMOT K3 may only be operated by authorized persons Make sure that the patient is supported in an anatomically correct way Check the following settings positioning 1 Femur length 2 knee joint axis 3 calf length and leg rotation setting 4 patient kits In case of patients who are adipose p
4. ART RO MOT K3 Operation Manual Device description 11 12 13 14 15 15 16 1 Knob for femur length adjustment 11 Socket for power adapter 2 Base 12 Knurled knob for rotating foot 3 Coiled cord plate 4 Controller cable 13 Kit straps 5 Hand held controller 14 Lower leg patient kit 6 Knurled knob for length adjust 15 Knee pivot point ment of lower leg 16 Thigh patient kit 7 Power adapter 8 On Off switch 9 Knurled knob for angle of foot inclination 10 Footplate with patient kit Contents 1 How to use ARTROMOT K3 1 1 Application 1 2 Objectives of therapy 1 3 Indications 2 Description of the ARTROMOT K3 3 Safetv instructions 4 Adjusting the device 4 1 Connecting the device 4 2 Adjusting the femur length 4 3 Adjusting the supports 5 Setting the treatment values 5 1 Programming the ARTROMOT K3 5 1 1 Programming the treatment values 5 1 2 Information about treatment values 5 1 3 Programming the special functions 6 Maintenance Specifications 8 Service 9 Declaration of conformity 10 Figures JS PS HS N NNN WO OO CO CO CO 10 11 12 17 1 How to use ARTROMOT K3 1 1 Application The ARTROMOT K3 is a motor Operated motion device used for Continuous Passive Motion CPM of the knee and hip joints Suitable for use in hospitals clinics general practices and rental services it is an import
5. ability if used improperly Speed Minimum setting for speed 1 Maximum setting for speed 100 5 1 3 Programming the special functions Special functions are Center warm up Full speed amp motion double speed setting Runtime patient runtime Device runtime Programming the special functions 1 Switch to programming mode section 5 1 1 2 Press FUNC key 3 Select special functions using or key 4 Follow the instructions on the display 5 Quit and save with STOP button Center warm up Warm up allows the patient to attain gradually full programmed range of motion The device starts in the middle between the two values set for extension and fle xion With each movement cycle the extent of movement is increased by 2 degrees until the set value is reached The device then moves between these values Full speed amp motion The full speed amp motion function is only for service The device runs at twice the maximum programmable speed to faci litate a rapid device set up WARNING Do not run the device in full speed amp motion when patient is in the device Run time This is the individual run time for each treatment To reset press SET key in the programming mode Device run time The total device run time is counted from the first usage of the device Press button for 5 seconds until setting appears D
6. ant supplement to medical and therapeutic treatment 1 2 Objectives of therapy CPM therapy with ARTROMOT K3 is mainly used in the avoidance of immo bilization injuries the early re establish ment of painless movement of joints and the promotion of faster healing with a positive functional result Other objectives of therapy include the improvement of joint metabolism the prevention of joint stiffness the promotion of the healing of cartilage areas and damaged ligaments the speeding up of haematoma resorbtion the improvement of lymph and blood circulation the prevention of thrombosis and embolism 1 3 Indications The ARTROMOT K3 CPM device is indicated in the treatment of most injuries postoperative states and diseases of the knee and hip joint For example joint distorsions and contusions arthrotomy and arthroscopy procedures in combination with synovectomy arthrolysis or other intra articular measures mobilizations of joints in narcosis operative treatments on fractures pseudarthrosis and inversion operations criciate ligament replacement surgery ACL PCL endoprothetic implants N CAUTION The ARTROMOT K3 should not be used with acute inflammatory processes in the joint area if not explicitly prescribed by the doctor Spastic paralysis unstable osteosynthesis Movement should not cause any pain
7. articular large or very small you Should pay attention to the following Avoid abrasion and pressure If necessary support the leg ina Slightly abductive position The maximum continuous load on the leg support element is 30 kg Movement must always be free of pain and irritation The patient must be fully conscious during instruction and when using the Splint The doctor or therapist must decide on a case to case basis wether the device can be used with the patient A CAUTION Before treatment begins a test run involving several movement cycles should be carried out first without and then with the patient The hand held programming unit should be explained to the patient and must be located within the patients reach so that the therapy can be interrupted if necessary Make sure that the characteristic values of your power supply correspond to the voltage and frequency data indicated on the ID plate Only connect the ARTROMOT K3 to correctly installed safety sockets Repair and maintenance work may only be carried out by authorized persons as otherwise all warranty services and liabilities shall be void Perform regular checks on all com ponents for possible damage or loose connections Damaged or worn parts should be replaced immediately with original Spare parts by an authorized specialist Before cleaning and repair disconnect the device from the main socke
8. evice run time cannot be deleted Save data To save the programmed special func tions press the STOP key Press the START key the device checks programmed values 6 Maintenance Always unplug the device before cleaning The ARTROMOT K3 can be wiped clean with disinfectant and therefore complies with the required standards of hygiene for medical equipment The housing can be cleaned using commonly available disinfectants and mild household detergents The device itself should only be wiped down with damp cloth CAUTION Never allow liquids to get inside the housing or hand held programming unit The plastics used are not resistant to mineral acids formic acid phenol cresol oxidizing or strong organic and inorganic acids with a pH value of less than 4 Protect the device from intensive ultraviolet radiation Sunlight Surrounding Conditions Surrounding temperature Relative humidity Air pressure 11 F to 140 F 20 to 85 700hPa to 1060 hPa Operational Conditions Surrounding temperature 50 F to 104 F Relative humidity 30 to 75 Air pressure 700hPa to 1060 hPa 10 7 Specifications Electrical rating 115 230V 50 60Hz 15V 27VA Input current 0 3 Amps Rated 1 33A Transformer Safety transformer EN 60742 Protection class II Length 36 6 inches 93 cm Width 14 inches 36 cm Height 16 53 inches without fo
9. ot plate 43 cm Length adjustment for lower leg approximate length 16 7 inches 42 5 cm 22 inches 56 cm Length adjustment for upper leg approximate length Weight Materials used 2 75 inches 7 cm 24 4 Ib 11 8 kg Steel 1 4301 1 4305 1 4310 Aluminium AIM 93 AlCuMgPb F38 Brass Synthetic material PA6 6 Polystyrol PVC PE 1000 FR4 Electronic board Polyurethane rubber Support synthetic fleece Polyester Technical data subject to change MPG Class 2a Power supply NTEV20 Safety Transformer In 115 230V 50 60 HZ 27VA Out 15V 1 33A Manufacturer Ulmer 8 Service If you have any questions regarding product or service please do not hesitate to contact us ORMED international Please contact your local dealer or Headquarters Germany ORMED GmbH amp Co KG Merzhauser Stra e 112 D 79100 Freiburg Germany Tel 49 761 4566 281 Fax 49 761 4566 55281 e mail S goerger ormed de USA St Paul Tel 1 800 440 2784 Fax1 651 415 7414 e mail rsuddendorf ormedusa com Czech Republic Prague Tel 420 2 84094650 Fax 420 2 84094660 e mail miroslav fila ormed cz Internet www ormed de e mail S goerger ormed de www ormedusa com Technical hotline Do you have any technical questions Do you need technical service Tel 49 180 51 ormed de 49 180 51 676 333 Fax 49 180 53 ormed de 49 180 53 676 333 11 AN CAUTION Carry out regular
10. red values 5 1 2 Information about treatment values Setting the range of motion ROM Maximun knee extension 5 degrees Maximum knee flexion 110 degrees 5 1 1 Programming the treatment values AN CAUTION The programmed value and the actual angle measured at the patients knee may vary IMPORTANT It is possible to program single or all parameters If only some parameters were changed the other parameters will be saved with current settings 1 Pressing the Extension and STOP keys at the same time for one second or holding down the STOP key for five seconds enables you to change to programming mode The criterion for correct adjustment is that it should be possible to move the extremity without pain or irritation Adjusting the pauses The pauses occur in the final position of extension or flexion and can be set separately for extension and flexion Possible values for pauses 0 30 seconds Adjusting the force reverse on load Minimum setting for reverse on load 25 kp Maximum setting for reverse on load 45 kp Settings are approximate Tensile force is measured on the frame around the foot The input setting determines the maxi mum resistance needed to automati cally reverse the direction of motion AN CAUTION The reverse circuit is purely a safety measure for cramps spasms locked joints etc The manufacturer accepts no li
11. t When carrying out any work on the device never allow liquids to get inside the housing or the hand held programming unit Only use the AC AC adapter supplied with the unit Z CAUTION The ARTROMOT K3 may only be operated with the attached power supply NTEV20 To disconnect the device from mains unplug the AC AC adapter from the wall socket 4 Adjusting the device Note Fold out pages 1 and 17 To get a better understanding of the individual steps 4 1 Connecting the device Connect the power adapter 7 to a safety socket 120 Volt 60 Hertz Turn on the device with the main switch 8 4 2 Adjusting the femur length Set the device at a knee angle position that is not likely to cause the patient any pain Positioning the upper leg Open the black knurled knob 1 and move thigh support to the desired length figure 2 Positioning the lower leg Loosen the two knobs 6 move the foot support horizontally and adjust precisely to the patients lower leg length figure 3 Positioning of foot dorsi plantar flexion Loosen the two knobs 9 and adjust the foot plate at a comfortable angle figure 4 Positioning of foot rotation Loosen the knurled knob 12 and move the foot plate into the required rotation position figure 5 4 3 Adjusting the patient kit Fix patient kit 14 for the lower leg and pa
12. tient kit 16 for the upper leg by using the velcro tapes figure 6 and figure 7 Control correct adjustment Exercise only in painfree range of motion Patient should be positioned with maximum comfort AN CAUTION The knee and hip axis of the ARTROMOT K3 should align with the patients knee and hip axis Figure 8 After adjustments have been made perform several test runs When correctly adjusted there should be no excursion of the knee and hip joint during motion 5 Setting the treatment values 5 1 Programming the ARTROMOT K3 The following treatment values can be stored bv means of the hand held programming unit 5 Knee extension Knee flexion Pause extension Pause flexion Force Speed Buttons to choose the parameters k be Li i Display Extension a Pause 3 Function Extension Pause r SET Flexion e Force mm H E y button 2 You can now select the treatment values in succession by pressing the parameter keys 3 Change the value by pressing the keys 4 Continue programming with 2 and 3 until all required values are entered 5 Press the STOP key to save all previous values 6 Press START button programmed values were checked automatically 7 Press START button again to start the device in therapy mode 8 Pressing the parameter buttons in stop mode the display shows the current sto
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