Operation Manual
8 Pages
Preview
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ARTROMOT®-K4
Operation Manual
Device description
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Figures
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Fig. 5
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Contents
1. How to use ARTROMOT®-K4
Device description
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Figures
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1. How to use ARTROMOT®-K4 1.1 Application 1.2 Objectives of therapy 1.3 Indications
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2. Description of the ARTROMOT®-K4
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3. Safety instructions
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4. Adjusting the device 4.1 Connecting the device 4.2 Adjusting the femur length 4.3 Adjusting the patient kit 4.4 Conversion
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5. Setting the treatment values 5.1 Programming the ARTROMOT®-K4 5.1.1 Programming the treatment values 5.1.2 Information about treatment values 5.1.3 Programming the special functions
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6. Maintenance
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1.1 Application
1.3 Indications
The ARTROMOT ®-K4 is a motoroperated motion device used for Continuous Passive Motion (CPM) of the knee and hip joints.
The ARTROMOT®-K4 CPM device is indicated in the treatment of most injuries, postoperative states and diseases of the knee and hip joint. For example:
Suitable for use in hospitals, clinics, general practices and rental services, it is an important supplement to medical and therapeutic treatment.
– joint distorsions and contusions – arthrotomy and arthroscopy procedures in combination with synovectomy, arthrolysis or other intra articular measures
1.2 Objectives of therapy
– mobilsations of joints in narcosis – operative treatments on fractures, pseudarthrosis and inversion operations
CPM therapy with ARTROMOT ®-K4 is mainly used in the avoidence of immobilisation injuries, the early reestablishment of painless movement of joints and the promotion of faster healing with a positive functional result.
– criciate ligament replacement surgery (ACL /PCL) – endoprothetic implants
Other objectives of therapy include: – the improvement of joint meatbolism
7. Specifications
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8. Service
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9. Declaration of conformity
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PRECAUTION!
– the prevention of joint stiffness
The ARTROMOT®-K4 should not be used with:
– the promotion of the healing of cartilage areas and damaged ligaments
– acute inflammatory processes in the joint area, if not explicitly prescribed by the doctor
– the speeding up of haematoma resorbtion – the improvement of lymph and blood circulation
– spastic paralysis
– the prevention of thrombosis and embolism
Movement should not cause any pain.
– unstable osteosynthesis
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2. Description of the ARTROMOT®-K4 The ARTROMOT ®-K4 CPM device allows extension and flexion of the knee joint in the range of -10-0-125 degrees and of the hip joint in the range of 10-100 degrees.
15 Main switch
The ARTROMOT ®-K4 features a hand-held programming unit that can be used to program and store any treatment values.
18 Lower leg patient kit
16 Footplate with patient kit 17 Lower leg support
3. Safety instructions
these instructions must be read before start-up!
21 Thigh support 22 Knob for femur length adjustment 23 Hip axis pivot point
Explanation of the functioning elements
– Make sure that the patient is supported in an anatomically correct way. Check the following settings /positioning:
2. Knee joint axis 3. Hip joint axis
– Damaged or worn parts should be replaced immediately with original spare parts by an authorised specialist.
– In case of patients who are adipose, particular large or very small, you should pay attention to the following:
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Spare tube
– Avoid abrasion and pressure
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Release tubes for square tube
– If necessary support the leg in a slightly abductive position.
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Patient kit strapes
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Coiled cord
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Controller cable
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– Perform regular checks on all components for possible damage or loose connections.
5. Patient kits
Button for heigth adjustment of hip pivot point
Knob for length adjustment of lower leg
– Repair and maintenance work may only be carried out by authorised persons, as otherwise all warranty services and liabilities shall be void.
1. Femur length
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– Only connect the ARTROMOT®-K4 to correctly installed safty sockets.
4. Calf length and leg rotation setting
Note: Fold out page 2
Hand-held programming unit
– Make sure that the characteristic values of your power supply correspond to the voltage and frequency data indicated on the ID plate.
– The ARTROMOT®-K4 may only be operated by authorised persons.
19 Knee pivot point 20 Thigh patient kit
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– The hand-held programming unit should be explained to the patient and must be located within the patient’s reach, so that the therapy can be interrupted if necessary.
PRECAUTION!
– Before cleaning and repair disconnect the device from the main socket. – When carrying out any work on the device, never allow liquids to get inside the housing or the hand-held programming unit.
– The maximum continuous load on the leg support element is 30 kg. – Movement must always be free of pain and irritation.
– Only use the AC-AC adapter supplied with the unit.
– The patient must be fully conscious during instruction and when using the splint. Explanation of symbols
Base
Alternating current
PRECAUTION!
– The doctor or therapist must decide on a case-to-case basis whether the device can be used with the patient.
The ARTROMOT®-K4 may only be operated with the attached power supply NTEV20.
Protective system Type B
10 Knob for angle adjustment of foot inclination
Power off 11 Knob for rotation footplate Power on 12 Power adapter Device off
PRECAUTION!
To disconnect the device from mains, unplug the AC-AC adapter from the wall socket.
Before treatment begins, a test run involving several movement cycles should be carried out first without and then with the patient.
13 Cable of power adapter Device on 14 Socket for power adapter 6
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4. Adjusting the device
4.4 Conversion
Note: Fold out pages 2 and 3. To get a better understanding of the individual steps.
4.3 Adjusting the patient kit – Fix patient kit (18) for the lower leg and patient kit (20) for the upper leg by using the velcro tapes (figure 6 and figure 7).
4.1 Connecting the device
– Control correct adjustment. Exercise only in painfree range of motion. Patient should be positioned with maximum comfort.
– Connect the power adapter (7) to a to a safety socket (120 Volt, 60 Hertz) – Turn on the device with the main switch (15)
PRECAUTION! For correct insert and lock position of the bayonet lock refer to sticker on the device.
ARTROMOT®-K4 features a true anatomical knee and hip axis for maximum patient comfort. ARTROMOT®-K4 has to be set up either for the right or left leg.
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The device can be converted quickly. The procedure is easiest at an angle of approximatly 80 – 90 degrees (section 5.1.1). – Hand-held programming unit (7) is in STOP mode. – Press buttons (3) simultaneously and pull square tube (2) associated with the heigth adjustment mechanism out from profile (figure 11). Slide into the opposite profile until it “clicks” home audibly.
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4.2 Adjusting the femur length
PRECAUTION! The knee and hip axis of the ARTROMOT®-K4 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.
Set the device at knee-angle position that is not likely to cause the patient any pain. Positioning the upper leg – Open the black knurled knob (22), push button and move thigh support (21) to the desired length (figure 2). – For correct alignment of the hip axis pivot point (23) and anatomical hip axis of the patient pull button (1) and align pivot point (23) to height of trochanter major of the patient.
Fig. 12 – Pull button for height adjustment mechanism (1) and remove thigh support (21) (figure 9). Fig. 10 – Slide the height adjustment elements together again and allow hinge to click home at the same height as the turning point of the hip (figure 12).
Positioning the lower leg – Loosen the two knobs (8), move the foot support horizontally and adjust precisely to the patients lower leg length (figure 3).
– Hold the thigh support. Release length adjustment mechanism (1/4 rotation) from the bayonet lock (figure 10). Remove entire part and slide into the opposite side and fix in place with the bayonet lock.
Positioning of foot dorsi-/ plantar flexion – Loosen the two knobs (10) and adjust the foot plate at a comfortable angle (figure 4). Positioning of foot rotation – Loosen the knurled knob (11) and move the foot plate into the required rotation position (figure 5). 8
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Adjusting the force (reverse on load)
5. Setting the treatment values 2. You can now select the treatment values in succesion by pressing the parameter keys.
5.1 Programming the ARTROMOT®-K4 The following treatment values can be stored by means of the hand-held programming unit. (7)
– Knee flexion
Settings are aproximate! Tensile force is measured on the frame around the foot.
4. Continue programming (with 2 and 3) until all required values are entered.
The input setting determines the maximum resistance needed to automatically reverse the direction of motion.
Full speed & motion
6. Press START button: programme values were checked automatically.
– Pause extension – Pause flexion
7. Press START button again to start the device in therapy mode.
– Force – Speed
8. Pressing the parameter buttons in stop mode the display shows the current stored values.
Fig. 1
Warm up allows the patient gradually attain full programmed range of motion. The device starts in the middle between the two values set for extension and flexion. 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.
– Maximum setting for reverse on load: 45 kp
3. Change the value by pressing the +/- keys.
5. Press the STOP key to save all previous values.
– Knee extension
Center warm up
– Minimum setting for reverse on load: 25 kp
PRECAUTION!
The full speed & motion function is only for service. The device runs at twice the maximum programmable speed to facilitate a rapid device set up.
The reverse circuit is purely a safty measure for cramps, spasms, locked joints, etc. The manufacturer accepts no liability if used improperly.
WARNING: Do not run the device in full speed & motion when patient is in the device!
Speed Buttons to choose the parameters:
Display
Extension
STOP
Flexion Pause Extension Pause Flexion
Function
Force
“+” button
Speed
“–” button
5.1.2 Information about treatment values
START
Setting the range of motion ROM – Maximun knee extension: -10 degrees
“SET“
Minimum setting for speed: 1%
Run time
Maximum setting for speed: 100 % The individual run time for each treatment. To reset press SET key in the programming mode.
5.1.3 Programming the special functions
Device run time
– Maximum knee flexion: 125 degrees Special functions are:
PRECAUTION! The programmed value and the actual angle measured at the patient´s knee may vary.
5.1.1 Programming the treatment values
The total device run time is counted from the first usage of the device. Press + button for 5 seconds until setting appears. Device run time cannot be deleted.
– Center warm up – Full speed & motion (double speed setting) – Runtime (patient runtime) – Device runtime
The criterion for correct adjustment is that it should be possible to move the extremity without pain or irritation.
IMPORTANT: It is possible to program single or all parameters. If only some parametres were changed, the other parameters will be saved with current settings.
Adjusting the pauses – The pauses occur in the final position of extension of flexion and can be set seperately for extension and flexion.
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.
– Possible values for pauses: 0–30 seconds.
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Save data
Programming the special functions: To save the programmed special functions, press the STOP key.
1. Switch to programming mode (section 5.1.1)
Press the START key: the device checks programmed values.
2. Press FUNC key 3. Select special funtions using + or - key 4. Follow the instructions on the display 5. Quit and save with STOP button
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6. Maintenance
7. Specifications
– Always unplug the device before cleaning – The ARTROMOT®-K4 can be wiped clean with desinfectant 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.
Electrical rating
115 V/230 V~ 50/60 Hz 15 V/ 27 VA
Input current
0.3 Amps
Rated
1.33 A
Transformer
Safety transformer EN 60742
Protection class
II
Length
45.27 inches/115 cm
Width
15.5 inches/ 39.5 cm
Height
21.7 inches /55 cm
Length adjustment for lower leg 15.5 inches/ 39.5 cm - 22 inches /56 cm
PRECAUTION! Never allow liquids to get inside the housing or hand-held programming unit.
Length adjustment for upper leg 12.5 inches /32 cm (approximate length) -19.7 inches / 50 cm
– The plastics used are not resistant to mineral acids, formic acid, phenol, cresol, oxidising or strong organic and inorganic acids with a pH value of less than 4.
Weigth
26 lb. /13 kg
Materials used
Steel: 1.4301; 1.4305; 1.4310 Aluminium: AlMg3; AlCuMgPb F38, Brass Synthetic material: PA6.6; Polystyrol PVC; PE 1000; FR4 Electronic board; Polyurethane; rubber Support: synthetic fleece (Polyester)
– Protect the device from intensive ultraviolet radiation (sunlight).
Surrounding Conditions Surrounding temperature -11O F to +140 O F Relative humidity 20 % to 85 % Air pressure 700 hPa to 1060 hPa
Technical data subject to change
Operational Conditions Surrounding temperature + 50O F to + 104O F Relative humidity 30 % to 75 % Air pressure 700 hPa to 1060 hPa
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MPG:
Class 2a
Power supply
NTEV20 Safety Transformer In: 115 /230 V ~ 50/60 HZ, 27 VA Out: 15 V ~ 1.33 A Manufacturer: Ulmer
8. Service
PRECAUTION! Carry out regular 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.
If you have any questions regarding product or service, please do not hesitate to contact us: ORMED international Please contact your local dealer or
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.
Headquarters Germany ORMED GmbH & Co. KG Merzhauser Straße 112 D-79100 Freiburg, Germany Tel. +49-(0)-761-4566-281 Fax +49-(0)-761-4566-55 281 e-mail: [email protected]
Maintenance: Not necessary
USA, St. Paul Tel. 1-800-440-2784 Fax 1-651-415-7414 e-mail: [email protected]
Guarantee: 2 years warranty on mechanical and electronical parts Manufacturer: ORMED GmbH & Co. KG Merzhauser Straße 112 D-79100 Freiburg
Czech Republic, Prague Tel. 02-84094650 Fax 02-84094660 e-mail: [email protected] Internet: www.ormed.de e-mail: [email protected] www.ormedusa.com
Technical hotline: Do you have any technical questions? Do you need Technical service? Tel. +49-180-5-1-ormed.de +49-180-5-1-676 333 Fax +49-180-5-3-ormed.de +49-180-5-3-676 333
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According to the EC-Regulation for medical devices the EC Medical Devices Directive (MDD) 93/42/EEC dated 14th June 1993, appendix 2
The Manufacturer ORMED GmbH & Co. KG Merzhauser Straße 112 D-79100 Freiburg herewith declares that the following units Type Name
Knee & Hip ARTROMOT ®-K4
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, January 20, 2002 Quality Control Manager
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© ORMED 4/03
D E C L A R AT I O N O F C O N F O R M I T Y
Declaration of Conformity
Ormed GmbH & Co. KG • Merzhauser Straße 112 • D-79100 Freiburg • Phone ++49(0)761/45 66-281 F a x + + 4 9 ( 0 ) 7 6 1 / 45 6 6 - 5 5 2 8 1 • w w w . o r m e d . d e • e - m a i l : i n f o @ o r m e d . d e St. Paul/USA, Phone 001-800-4402784, Fax 001-651- 4157405 • Prague/CR, Phone 02-84094650, F a x 0 2 - 8 4 0 9 4 6 6 0 • V i e n n a / A , Te l 0 1 - 5 3 2 0 8 3 4 , F a x 0 1 - 5 3 2 0 8 3 4 - 3 1 DIN EN 46 001
ORMED Nr. 018 829-01
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