DJO Global Artromot Active-K Operating Instructions Manual
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DJO Global Artromot Active-K Operating Instructions Manual

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O P e r At i n G i n S t rU C t i O n S
ARTROMOT® ACTIVE-K
CPM · CAM · Coordination
US/GB ·
Operating Instructions SW2.X
Supplied by EME Services Ltd

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  • Page 1 O P e r At i n G i n S t rU C t i O n S ARTROMOT® ACTIVE-K CPM · CAM · Coordination US/GB · Operating Instructions SW2.X Supplied by EME Services Ltd...

  • Page 2: Table Of Contents

    Content 1. How to use the physiotherapy unit 1.1 Fields of application 1.2 Therapy objectives 1.3 Indications 1.4 Contraindications 1.5 Secondary effects 2. Description of the ARTROMOT® ACTIVE-K 2.1 Description of the device components 2.2 Description of the control pendant 2.3 Explanation of symbols 2.4 Explanation of symbols (connections and rating plate) 3.

  • Page 3: How To Use The Physiotherapy Unit

    1. How to use the physiotherapy unit (Intended Use) 1.1 Fields of application 1.3 Indications The ARTROMOT® ACTIVE-K is a motorized The physiotherapy unit is indicated in the treat- physiotherapy unit. It combines the benefits of ment of most injuries and diseases of the knee CPM therapy (= Continuous Passive Motion), and hip joints as well as in postoperative treat- post-operative mobilization, and CAM therapy...

  • Page 4: Description Of The Artromot® Active-K

    2. Description of the ARTROMOT® ACTIVE-K The motorized physiotherapy unit permits ac- tive and passive motion of the knee joint in the form of extension / flexion in the range of –10 – 0 – 120 degrees and of the hip joint in the form of extension / flexion in the range of 0 –...

  • Page 5: Description Of The Device Components

    2.1 Description of the device components 9 10 11 12 13 24 7 10 24 21 20 19 18 ACTIVE-K special www.DJOglobal.com 1. Thigh support assembly 14. Clamping lever to adjust the footplate rotation 2. Clamping lever to adjust the height of the thigh support assembly 15.

  • Page 6: Description Of The Control Pendant

    2.2 Description of the control pendant 2.2.1 Buttons on the control pendant Patient chip card stores the entered therapy parameter values MENU button Display displays the menu for setting the therapy parameters in each Return button operating mode used to return to the previous level Arrow to the right Arrow up...
  • Page 7 2.2.2 Control pendant with main menu Header showing: Currently highlighted function Current display/function Here: passive (CPM) Here: symbol for Main Menu Focus Scroll bar (field with blue indicates whether background) or not additional highlights the functions are currently select- available above able function or below the function currently...
  • Page 8 2.2.4 Control pendant in programming mode for functions that can be activated Selected parameter here: warm-up protocol Selected operating mode here: passive (CPM) Status of the selected function here: warm-up protocol inactive Symbol for When the function selected is activated, the parameter square is solid here: warm-up...

  • Page 9: Explanation Of Symbols

    2.3 Explanation of symbols 2.3.1 General treatment parameters Operating modes Passive (CPM) Active (CAM) Coordination Therapy protocols Protocols available for selection under "operating mode" Coordination: Maintain force, Maintain force, Find angle, passive Find angle, active Free training static dynamic Therapy protocols: Cruciate ligament Cartilage Total knee/hip...
  • Page 10 2.3.2 Other symbols Parameter Available functions/adjustments New Patient Documentation Total patient Therapy therapy time documentation Settings Language Brightness Volume Time/date selection Transport Total unit run time Service menu Lock-out function Lock-out function disabled Lock-out function Lock-out function Lock-out function Lock-out function enabled enabled enabled...

  • Page 11: Explanation Of Symbols (Connections And Rating Plate)

    2.4 Explanation of symbols (connections and rating plate) alternating current for serial numbers < 2,000: protection class I equipment. The medical device must be connected to a system with protective earth conductor! for serial numbers > 2,000: protection class II equipment. The medical device has a double or reinforced insulation.
  • Page 12 The IP rating indicates the level of protection and thus the suitability of the device for use under different ambient conditions. The rating IP21 means: 2 is the level of protection against contact and solid objects The digit 2 means: IP21 –...

  • Page 13: Safety Information

    3. Safety information Definitions − Before therapy, a test run consisting of sev- eral exercise cycles must be completed, first Read the safety statements before use of the without and then with the patient. Check physiotherapy unit. The safety statements are that all setting screws are tightened.
  • Page 14 − Do not allow parts of the body or objects − After use, store the device in a safe place! (such as blankets, cushions, or cables) to get Ensure device stability also during storage! caught in the moving parts of the physio- −...
  • Page 15 m Warning! m Caution! Equipment malfunction — Equipment damage — − Magnetic and electrical fields are capable − Check that the voltage and frequency of interfering with the proper performance ratings of your local power line are those of the unit. For this reason make sure that indicated on the rating plate.

  • Page 16: Device Setup

    4. Device setup Note: For an illustration of the individual Select the function with , then acti- device components, see page 5. vate the function by pressing the arrow up button 4.1 Connecting the unit, Confirm the selection with . The ini- performance check, tial screen for setting the unit to the home Equipment supplied...

  • Page 17: Connecting The External Muscle Stimulator

    3. Adjust the measured value at the femur Other cables are not approved. The cable can scale (3) of the carriage (Fig. B): be ordered separately from DJO Global. 1. Plug the jack into the ARTROSTIM® FOCUS® plus muscle stimulator. Fig. B •...

  • Page 18: Adapting The Leg Support Assemblies/Footplate

    4.4 Adapting the leg support assemblies/footplate 1. Set the leg support assemblies and the footplate (1, 6, 12) to the expected positions before accommodating the patient. • Loosen locking catch (9) to adjust the footplate (12) to the length of the patient's lower leg (Fig.
  • Page 19 Symbol 1: Measure the length of the patient's thigh (fe- mur) from the greater trochanter to the outer knee joint gap Symbol 2: Set the carriage to the home position (see 4.1) and adjust it to the measured femur length. Symbol 3: Adjust the height of calf and thigh support...

  • Page 20: Setting The Treatment Values

    5. Setting the treatment values This is what happens when you press the OK m Warning! button to select a parameter: Patient hazard — Before therapy, a test run − The corresponding symbol appears enlarged consisting of several exercise cycles must be on the display.
  • Page 21 Note You can choose among the following chip cards: – Refer to sections 5.2, 5.3 and 6 for a descrip- tion of the parameters. Limited to ACTIVE-K passive – To view the set parameters and the cur- CPM functions rently selected values, press the MENU www.DJOglobal.com button.

  • Page 22: Therapy Parameter Details

    5.2 Therapy parameter details 5.2.1 Overview of the parameters available in each operating mode Coordination Operating mode / Passive Active Maintain Maintain Find Find Free Parameter force, force, angle, angle, training static dynamic passive active Passive exten- sion (stretching) adjustment Passive flexion (bend- ing) adjustment Timer...
  • Page 23 5.2.2 Overview of the parameters available in each operating mode Passive extension (stretching) adjustment – maximum knee extension: -10 degrees – maximum hip extension: 10 degrees Passive flexion (bending) adjustment – maximum knee flexion: 120 degrees – maximum hip flexion: 115 degrees Note –...
  • Page 24 Warm-up protocol The warm-up protocol allows the patient to slowly become used to the set maximum values for extension and flexion. Once activated, the carriage first moves to the programmed maximum values minus 10° in each direction. Then both the flexion and extension range of motion is increased by 2° per cycle until the maximum range of motion is reached after 5 cycles.
  • Page 25 Muscle stimulation (EMS control) This special function allows the ARTROMOT® ACTIVE-K unit to be operated in conjunction with the electrical muscle stimulator ARTROSTIM® FOCUS®plus, for which it is ideally suited. For this modality, first plug the "muscle stimulation" connection cable (part no.
  • Page 26 Active ROM adjustment With this function, the patient is able to actively set the range of motion. Select the function with the OK button and activate it with the START button. The patient will then be prompted to bend and extend the knee. The carriage automatically saves the maximum extension and flexion values attained as the new range of motion.
  • Page 27 Flexion force This function allows you to set the magnitude and direction of the force for flexion movements in the active mode. The force can be adjusted between -30 kg and +30 kg in steps of 1 kg. Adjustable forces: 0 kg = passive mode, flexion 1 to 30 kg =...
  • Page 28 Extension force range The force range can only be set for the functions "Maintain force, static" and "Maintain force, dynamic". With these functions, the patient is prompted to maintain a random force for 3 seconds while the carriage is moving in the extension direction. The range from which the force will be selected, is set under Extension Force Range.
  • Page 29 Flexion force range The force range can only be set for the functions "Maintain force, static" and "Maintain force, dynamic". With these functions, the patient is prompted to maintain a random force for 3 seconds while the carriage is moving in the flexion direction. The range from which the force will be selected, is set under Flexion Force Range.

  • Page 30: Other Functions/Settings

    5.3 Other functions/settings 5.3.1 Therapy protocols This is the symbol for selection of therapy protocols: The therapy protocols allow you to run preprogrammed combinations of operating modes and specific functions in one session. Therapy protocols exist for the three most frequent indications. For rehabilitation after: −...
  • Page 31 Demo, for teaching the patient quickly what happens at the different levels of a therapy plan More, direct access to basic functions, such as "Settings”, “Load reversal” or “Documentation” m Caution! Patient hazard — To ensure patient safety, the reverse on load feature is always active in the passive operating mode of the carriage.
  • Page 32 5.3.1.1 Cruciate ligament (ACL/PCL) therapy protocol This is the symbol for the cruciate ligament (ACL) protocol: With the default therapy duration of 20 minutes, the session proceeds as follows: Levels Duration in Function/sequence Default parameters minutens Level 1 PASSIVE WARM-UP PASSIVE Level 2 PASSIVE WARM-UP...
  • Page 33 Levels Duration in Function/sequence Default parameters minutens Level 4 FREE TRAINING Extension: Push - 3 kg Flexion: Pull - 3 kg ACTIVE Extension: Push - 10 kg Flexion: Passive MAINTAIN FORCE, STATIC Extension: Push - 5 kg to 10 kg Flexion: Pull - 5 kg to 10 kg ACTIVE Extension: Push - 7 kg...
  • Page 34 Note – Preset parameters for all functions, unless otherwise stated: – speed: 50 % – active zone: 0° / 0° / 90° (for maximum setting, see 5.2.2). – The "cool-down" function is the opposite of the "warm-up" function. After the session, the carriage stops in the position equivalent to the set extension value + 10°.
  • Page 35 5.3.1.2 Cartilage therapy protocol This is the symbol for the cartilage protocol: With the default therapy duration of 20 minutes, the session proceeds as follows: Levels Duration in Function/sequence Default parameters minutens Level 1 PASSIVE WARM-UP PASSIVE Level 2 PASSIVE WARM-UP ACTIVE ACTIVE ZONE limited: 0°/10°/60°...
  • Page 36 Levels Duration in Function/sequence Default parameters minutens Level 4 PASSIVE WARM-UP ACTIVE Extension: Push - 6 kg Flexion: Pull - 4 kg MAINTAIN FORCE, STATIC Extension: Push - 5 kg to 8 kg Flexion: passive ACTIVE Extension: Push - 8 kg Flexion: Pull - 8 kg PASSIVE COOL - DOWN Level 5...
  • Page 37 Note – Preset parameters for all functions, unless otherwise stated: – speed: 50 % – active zone: 0° / 0° / 90° (for maximum setting, see 5.2.2). – The "cool-down" function is the opposite of the "warm-up" function. After the session, the carriage stops in the position equivalent to the set extension value + 10°.
  • Page 38 5.3.1.3 Total knee/hip replacement (TEP) therapy protocol This is the symbol for the total knee/hip replacement (TEP) protocol: With the default therapy duration of 20 minutes, the session proceeds as follows: Levels Duration in Function/sequence Default parameters minutens Level 1 PASSIVE WARM-UP PASSIVE Level 2...
  • Page 39 Levels Duration in Function/sequence Default parameters minutens Level 4 PASSIVE WARM-UP ACTIVE Extension: Push - 8 kg Flexion: Pull - 8 kg MAINTAIN FORCE, STATIC Extension: Push - 6 – 10 kg Flexion: Pull - 5 – 8 kg ACTIVE See above PASSIVE COOL - DOWN Level 5...
  • Page 40 Note – Preset parameters for all functions, unless otherwise stated: – speed: 50 % – active zone: 0° / 0° / 90° (for maximum setting, see 5.2.2). – The "cool-down" function is the opposite of the "warm-up" function. After the session, the carriage stops in the position equivalent to the set extension value + 10°.
  • Page 41 5.3.2 General functions New Patient With this function, the carriage will move to the home position (at 40° flexion), allowing the mechanical settings to be performed. All values stored on the chip card will be deleted. Press the OK button to select the function, press the arrow up button to activate the function and then press the OK button to confirm your selection.
  • Page 42 Documentation The Documentation function allows you to reproduce the therapy data saved by the carriage. The following documented data can be reviewed: Total patient therapy time The total patient therapy time is the added sum of operat- ing hours stored on the chip card. (added sum of all therapy sessions stored on the chip card) Deleting the stored therapy time on the chip card: Select the function with the OK button: the stored period...
  • Page 43 Settings With Settings you access the setup menu. From this menu, a number of basic settings for the carriage can be performed. Adjustable parameters: Language selection You can choose the following languages: – Danish – German – English – French –...
  • Page 44 Total unit run time The total unit run time is the overall number of carriage operating hours stored in the unit. (added sum of all stored therapy sessions) Deleting the stored therapy time: Select the function with the OK button: the stored period of time will be displayed with large digits.
  • Page 45 Lock-out function With the lock-out function, access to individual operating modes or functions can be blocked. This reduces the scope of programming options and makes operation easier. To activate the lock-out feature, simultaneously press the arrow left and arrow right buttons for approx. 4 seconds. The carriage must be in the stop mode of the operating mode concerned (no active menu).

  • Page 46: Operating Mode Details

    6. Operating mode details The ARTROMOT® ACTIVE-K offers three operat- 6.1.1 Adjustable CPM parameters ing modes for early functional rehabilitation therapy: – Passive (CPM) mode – Active (CAM) mode Passive extension (stretching) adjustment – Coordination In the "coordination" mode, you can choose from five specialized protocols to further en- Passive flexion (bending) hance the patient's coordination capabilities.
  • Page 47 6.1.2 Display in CPM mode elapsed therapy time OR, if the timer is activated remaining therapy time dialog field, indication of the indication active function: current position movement in exten- of the carriage sion and flexion here: 23° current direc- indication of the over- tion of the all available ROM...

  • Page 48: Active Operating Mode (Cam)

    Example of a range of motion greater than 6.2 Active operating mode (CAM) the preset active zone: Set range of motion: 5° / 0° / 110° Set active zone: 0° / 0° / 90° (maximum setting) The active operating mode (CAM – Controlled True active zone: 0°...
  • Page 49 6.2.1 Adjustable CAM parameters In the CAM mode, the following treatment parameters can be adjusted: Passive extension Active zone (stretching) adjustment Passive flexion (bending) Load reversal (passive) adjustment Therapy timer Speed Warm-up protocol (passive) Extension pause Flexion pause Active adjustment (ROM - range of motion) Extension force Flexion force...
  • Page 50 6.2.2 Display in CAM mode zone/range of force elapsed therapy indication of the cur- time rently exerted and OR, if the timer is requested force: activated remaining therapy – red: too much force time – green: tolerance range for force to be dialog field exerted indication of the...

  • Page 51: Coordination Mode

    6.3.1 Information about 6.3 Coordination mode the "maintain force" coordination protocols The coordination mode offers five different pro- tocols that help improve the coordination skills. The "maintain force" coordination protocols re- This is the symbol for the coordination mode: quire the patient in regular intervals to maintain a random force either in the direction of the carriage movement or in the opposite direction for 4 seconds.
  • Page 52 Maintain force, static If the "Maintain force, static" function is acti- Passive flexion (bending) vated, the patient is required to maintain the adjustment requested force for 4 seconds. The carriage will not move during this period, it stands still (static). A progress bar in the dialog window indicates the elapsed time.
  • Page 53 6.3.1.2 Display in the force range setting mode symbol for the currently selected parameter here: setting the ex- set upper limit of tension force range the force range for random selection here: 14 kg pressure set lower limit of buttons to change settings the force range for or confirm entries random selection...
  • Page 54 6.3.1.3 Display in the "maintain force, active" mode The display is essentially the same as in the "active" mode. In addition, a progress indicator is shown in the dialog window below the arrow indicating the direction of the requested force. progress bar (completely filled out = 4 seconds)
  • Page 55 If the carriage is stopped with OK, the requested 6.3.2 Information about the angle as well as the actual angle are is displayed. "Find angle, passive" Patient treatment can be resumed by pressing coordination protocols the OK button. Subsequently, the patient will be prompted for the next angle.
  • Page 56 6.3.2.1 Adjustable parameters in the "Find angle, passive" protocol The following treatment parameters can be adjusted in the "Find angle, passive" coordina- tion protocols: Passive extension (stretching) adjustment Passive flexion (bending) adjustment Therapy timer Speed Warm-up protocol (passive) Active adjustment (ROM - range of motion) Load reversal (passive) Supplied by EME Services Ltd...
  • Page 57 6.3.2.2 Display in the "Find angle, passive" programming mode The programming mode display is essentially the same as for adjustment of the passive ROM. Addi- tionally, during adjustment of the maximum extension and flexion angles, the angles to attain within the ROM are marked yellow on the ROM bar indicator.
  • Page 58 6.3.2.3 Display in the "Find angle" mode elapsed therapy time prompt to search OR, if the timer is for angles activated remaining therapy time symbol indicat- ing the angle to find indication of successful/failed attempts to search for angles prompt to find angles and to press OK when done...
  • Page 59 6.3.2.4 Feedback display with deviation between set and actual angle rating indication of requested and attained angles and deviation here: sum of successful/ failed attempts – 60° requested – stopped at 50° – deviation -10° prompt to press OK to continue the treatment indication of the deviation indication: blinking...
  • Page 60 6.3.3 Information about the 6.3.3.1 Adjustable parameters "Find angle, active" in the "Find angle, active" coordination protocol protocol This is the symbol for the "Find angle, active" The following treatment parameters can be protocol: adjusted in the "Find angle, active" coordination protocols: Passive extension (stretching) adjustment...
  • Page 61 6.3.4 Information about the "free training" coordination protocol The "free training" coordination protocol allows the patient to actively exercise over the entire range of motion of 10° / 0° / 120° of the ARTRO- MOT® ACTIVE-K. As soon as you enable the function and press the START button, the patient will be prompted to actively bend and extend the knee.
  • Page 62 6.3.4.2 Display in the "free training" mode The display is essentially the same as in the active setting of the range of motion. In addition, patients are given a positive feedback when they attain a greater extension and flexion angle. positive feedback when the angle reached is greater...

  • Page 63: Care, Maintenance, Transport

    7. Care, Maintenance, Transport 7.2 Maintenance 7.1 Care (fuse replacement) m Warning! − Check before each use Shock hazard — Unplug the device from the power line before cleaning. Visually inspect the device for signs of me- chanical damage before each use. Shock hazard, equipment damage–Liquids must not enter the device or the control If you detect damage or malfunctions that...

  • Page 64: Transport

    − Fuse replacement 7.3 Transport m Warning! The following operating steps must be com- Patient hazard, equipment malfunction and pleted before transporting the ARTROMOT® damage — ACTIVE-K : The replacement of fuses must be referred 1. Adjust the carriage to a femur length of to specialists as defined in IEC 60364 or other 49 cm and a tibia length of 42 cm.

  • Page 65: Environmental Protection Statement

    6 years hold or municipal waste. It requires separate dis- minimum. posal. Please contact DJO Global for information about the possible recycling of the product. 9. Specifications Model: ARTROMOT®...
  • Page 66 Adjustment ranges (min./max.): femur range: approx. 31 to 49 cm lower leg range: approx. 38 to 58 cm Accuracy of measured values: goniometer in the measuring range: from -10° to +120° accuracy: +/- 3° force gauge in the measuring range: from -30 kg to +30 kg accuracy: +/-1 kg...

  • Page 67: Iec 60601-1-2:2007 And Iec 60601-1-11:2010

    10. IEC 60601-1-2:2007 and IEC 60601-1-11:2010 The ARTROMOT®-K1 device is subject to par- If it is necessary to replace assemblies or cables, ticular precautions regarding electromagnetic only the manufacturer's original parts must be compatibility (EMC). The device must be installed used to ensure continued compliance with EMC and put into service strictly in compliance with requirements after repair.

  • Page 68: Electromagnetic Immunity

    10.2 Electromagnetic immunity Guidance and Manufacturer’s Declaration – Electromagnetic Immunity ARTROMOT® ACTIVE-K is intended for use in the electromagnetic environment specified below. It is the responsibility of the customer or user to ensure that the ARTROMOT® ACTIVE-K unit is used in such an environment.
  • Page 69 Guidance and Manufacturer’s Declaration – Electromagnetic Immunity ARTROMOT® ACTIVE-K is intended for use in the electromagnetic environment specified below. It is the responsibility of the customer or user to ensure that the ARTROMOT® ACTIVE-K unit is used in such an environment. Immunity test IEC 60601 test level Compliance level Electromagnetic environ- ment - guidance...

  • Page 70: Recommended Separation Distances

    10.3 Recommended separation distances Recommended separation distances between portable and mobile RF telecommunications equipment and the ARTROMOT® ACTIVE-K The ARTROMOT® ACTIVE-K is intended for use in an electromagnetic environment in which radi- ated RF disturbances are controlled. The customer or the user of the ARTROMOT®-ACTIVE-K can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF telecommunications equipment (transmitters) and the ARTROMOT®...

  • Page 71: Contact

    We would be happy to answer any questions you may have about our products and services. ARTROMOT® International: Please contact your local dealer, the DJO Global Headquarters in the USA, the DJO Global Inter- national Headquarters in England or DJO Global in Germany.

  • Page 72: Technical Service

    +49-180-5-3 67 63 33 12.2 Shipment To prevent damage during transport, only use the original shipping box. These boxes can be obtained from DJO Global. Before packing the therapy unit, set it to the transport position (see chapter 7). 12.3 Spare parts Refer to the Service Manual for the most recent list of spare parts.

  • Page 73: Accessories And Parts For Use With The Device

    13. Accessories and Parts for Use with the Device Item Description Part no. Patient chip cards ARTROMOT® ACTIVE-K Passive – blue (CPM functions only) 0.0040.210 Active – green (CAM functions only) 0.0040.211 Protocol – orange (therapy plans only) 0.0040.212 Special – red (free programming) 0.0040.213 Marker pen for patient chip card 0.0031.006...

  • Page 74: Declaration Of Conformity

    Declaration of conformity In compliance with the Council Directive 93/42/EEC of 14 June 1993 about medical devices, the company ORMED GmbH Merzhauser Strasse 112 D-79100 Freiburg - Germany declares under its sole responsibility that the products of the product line ARTROMOT®...
  • Page 75 DIN EN 13485 ORMED Nr. 018 829-01 Manufacturer: ORMED GmbH Merzhauser Str. 112 · 79100 Freiburg · Germany Tel. +49 761 4566-01 · Fax +49 761 4566-5501 medizintechnik@DJOglobal.com · www.DJOglobal.de Supplied by EME Services Ltd...

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