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Astar PhysioMG User Manual

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PhysioMG –
User Manual

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Summary of Contents for Astar PhysioMG

  • Page 1 PhysioMG – User Manual...

  • Page 3: Table Of Contents

    1. Basic information and contents Contents INTRODUCTION ............................... 5 ................................5 ANUFACTURER .............................. 5 ISK MANAGEMENT PROCESS INTENDED USE ................................. 6 ................................6 NTENDED USERS ................................7 SER TRAINING WARRANTY AND MANUFACTURER'S RESPONSIBILITY....................8 OPERATIONAL SAFETY ............................. 9 ..........................9 AINS SUPPLY AND OPERATION MODE ........................
  • Page 4 Table 1. Available models of the PhysioMG unit ........................6 Table 2. Recommendations for the operation of touch screens ....................13 Table 3. Permissible configurations of applicators in the sockets of various models of PhysioMG ......... 21 Table 4. Signaling special messages ............................49 Table 5.

  • Page 5: Introduction

    These differences may concern size and type of fonts and size of symbols. There are no differences in the content of shown information. WARNING: No modification of this equipment is allowed! 1.1 Manufacturer ASTAR Sp. z o.o. UL. ŚWIT 33 43-382 BIELSKO-BIAŁA, POLAND www.astar.eu 1.2 Risk management process...

  • Page 6: Intended Use

    2. Intended use 2. Intended use The PhysioMG unit is an active, non-invasive therapeutic device, intended for carrying out treatment procedures using low frequency magnetic field generated by dedicated applicators. The magnetic field can be used to treat conditions in the following areas: •...

  • Page 7: Intended Users

    2.2 User training The PhysioMG user has to be properly trained in the device safe and effective use, before starting the operation. Training in the rules of operation can be carried out by representatives of the manufacturer or seller, based on this user manual.

  • Page 8: Warranty And Manufacturer's Responsibility

    On demand, the manufacturer makes available technical diagrams, parts lists, descriptions, instructions for calibration or other helpful information to appropriately qualified user's technical staff to repair these parts of unit, which are described by the producer as a reparable. User Manual – PhysioMG Page 8 / 58...

  • Page 9: Operational Safety

    4.1 Mains supply and operation mode The PhysioMG unit is designed for supply from AC mains with rating 230V ± 10%, 50/60Hz. It is a medical device under safety class I, type BF. The unit may be used only in rooms, where the electric system is executed in compliance with standards in force.
  • Page 10 Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the PhysioMG, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.
  • Page 11 4. Operational safety Occupational Health and Safety – magnetotherapy: During the treatment carried out near the head, the patient should wear protective glasses (they are • part of the equipment). The solenoid applicators and CP type plate applicator are equipped with electroluminescent light indicators signaling the generation of magnetic field.

  • Page 12: Applied Parts And Working Temperature

    The unit must be separated from the mains before approaching the disinfection room, where it is installed. 4.6 Electromagnetic environment Warnings concerning electromagnetic compatibility are given in the chapter 4.3. The expected places of operation of the unit are given in Chapter 2. User Manual – PhysioMG Page 12 / 58...

  • Page 13: Operation Of Touch-Sensitive Displays

    4.8 Technical supervision The User of PhysioMG unit must perform technical inspection of the unit at year intervals. The inspection should be performed by a unit authorized by the manufacturer. The inspection is performed at the user's expense.

  • Page 14: Disposal

    The unit is marked with an appropriate symbol complying with the directive on waste electrical and electronic equipment (WEEE) – see table with description of the symbols used to label the product presented in Appendix A. User Manual – PhysioMG Page 14 / 58...

  • Page 15: Unit Description

    Low frequency magnetic field therapy unit PhysioMG is a highly specialized medical device based on modern microprocessor platform. The unit has a plastic console casing. PhysioMG 827 (Figure 5.1) is equipped with a 17.8 cm (7 ") color touch liquid-crystal display, and PhysioMG 825 and 815 (Figure 5.2) with a 12.7 cm (5") display. The mains switch, fuse socket and mains socket are located on the rear side of the casing.

  • Page 16: Keyboard

    5. Unit description 5.2 Keyboard Arrangement of keyboard components is shown in figure 5.3. Figure 5.3 Arrangement of keyboard components on the example of PhysioMG 827 Arrangement of keyboard components” Symbol Description Function The indicator determines the readiness for operation: •...

  • Page 17: Magnetic Field Applicators

    5. Unit description 5.3 Magnetic field applicators The following types of solenoid applicators can be used with Physio MG (depending on a model, see 6.1.1) (Figure 5.4): • CS35 – solenoid applicator with a diameter of 35 cm, CS60 – solenoid applicator with a diameter of 60 cm, •...
  • Page 18 The stand is equipped with four castors, each with a brake. The LED indicators used in the magnetic field applicators are orange. Figure 5.7. CP applicators on a stand User Manual – PhysioMG Page 18 / 58...

  • Page 19: Name Plates

    5. Unit description Figure 5.8. CPEP applicators Detailed information on the parameters of the unit and applicators is given in chapters 8 and 11. 5.4 Name plates The name plate is located on the side of unit casing. Among others there are following data placed on the name plate (see Appendix A): •...

  • Page 20: Device Installation And Start-Up

    Depending on the model of the unit, connect the applicator to the appropriate socket. In order to facilitate the connections, the socket label contains indications which sockets the applicators can be connected to. Figure 6.1 View of the PhysioMG 827 sockets label Sockets label:...
  • Page 21 6. Device installation and start-up Figure 6.2 View of the PhysioMG 825 sockets label Figure 6.3 View of the PhysioMG 815 sockets label Table 3. Permissible configurations of applicators in the sockets of various models of PhysioMG Model Designation of a socket...

  • Page 22: First Operation

    The user is free to select language options. To set the language version, press the Language button in the list of setup options, then press the desired version. Language version change is immediate. User Manual – PhysioMG Page 22 / 58...

  • Page 23: Global Settings

    6. Device installation and start-up 6.2.3 Global settings 6.2.3.1 Date and time In this section there is a possibility to adjust date and time. To change these settings, press the button Edit. Using arrows, set the required value. Confirm settings using Set button or leave the edition mode by pressing Cancel.

  • Page 24: Service

    The function by the Delete user programs button allows you to remove user-defined programs. Selecting or unselecting the Test the touch panel check box allows to check the touch screen operation – on the touched spots an indicator occurs. User Manual – PhysioMG Page 24 / 58...

  • Page 25: Statistics

    6. Device installation and start-up In models 815 and 825, selecting the Test the touch panel button starts the display calibration procedure. Follow the messages on the screen. First, touch three points, then validate the operation by touching five points on the screen. 6.2.5.2 Date of inspection There is possibility to enter into the device the date of the next inspection –...
  • Page 26 6. Device installation and start-up Figure 6.6. Transport position of the trolley User Manual – PhysioMG Page 26 / 58...

  • Page 27: Unit Operation

    7. Unit operation 7. Unit operation The unit may operate in one of two modes: program mode, • manual mode. • In the program mode you can use preset procedures of treatment programs, user-defined programs and sequences. In the program mode you cannot edit the introduced parameters. Such an option is available in the manual operation mode.

  • Page 28: Screen Configuration

    Manual mode Main menu User-defined treatment programs and sequences edition mode Information mode Setup mode Note: If the edition / main menu field is grayed out, it means that it is inactive. User Manual – PhysioMG Page 28 / 58...

  • Page 29: General Configuration

    7. Unit operation 7.3 General configuration 7.3.1 Treatment channel configuration – for two-channel models Sample configuration of applicators in therapeutic channels, based on the example of PhysioMG 827: Channel Applicators Solenoid applicator CS60 Plate applicator CPEP Dual mode (see 7.5)

  • Page 30: Display Description

    Figure 7.3. An example of the appearance of a treatment screen for magnetotherapy treatment – a single applicator Magnetotherapy treatment screen – single applicator: Symbol Description Applicator identifier / program name. Magnetic induction. Tab field (channel 2). Indication of the treatment elapsing time. User Manual – PhysioMG Page 30 / 58...

  • Page 31: Dual Mode

    7. Unit operation Figure 7.4. An example of the appearance of a treatment screen for magnetotherapy treatment – dual mode Treatment screen of magnetotherapy – dual mode: Symbol Description Applicators identifiers / program name. Magnetic induction of the plate applicator CPEP. Magnetic induction of the solenoid applicator (herein CS75).

  • Page 32: Application Of Magnetic Field

    7. Unit operation 7.6 Application of magnetic field The illustrations below show examples of magnetic field application. Applicator Example CS60 / CS75 CS35 CPEP Figure 7.6 Examples of magnetic field application User Manual – PhysioMG Page 32 / 58...

  • Page 33: Operation With Preset Treatment Programs

    7. Unit operation 7.7 Operation with preset treatment programs The simplest method of unit operation is to use its preset programs. The unit includes a database containing several dozens of most frequently met disorders together with suggested treatment types and parameters. In this mode, the operation is reduced to selection of disease entity from the list.
  • Page 34 Figure 7.1 Sample view of the enlarged illustration If it is necessary to interrupt the treatment procedure (pause), press key. To resume the treatment procedure, it is recommended to follow the instructions shown on the display. User Manual – PhysioMG Page 34 / 58...

  • Page 35: Favorite Programs

    7. Unit operation 7.8 Favorite programs The function offers quick access to frequently used preset programs without browsing the entire list. To add or remove the program from the favorite list, follow the instructions: Step Description Prepare the unit to work with preset treatment programs (see steps 1-5 described in section 7.6). Select program.
  • Page 36 Select the option User programs from Program modes menu. Confirm by the key or once again press the selected field. Select the program which parameters will be checked. Press button Press the key or button to return to the user-defined treatment program list. User Manual – PhysioMG Page 36 / 58...

  • Page 37: User Sequences

    7. Unit operation 7.11 User sequences The unit is equipped with an advanced editor which allows you to create magnetotherapy treatment sequences (excluding the dual mode). A single sequence may consist of up to four stages. The sequence may be created from previously saved user-defined programs.
  • Page 38 Select the option User sequences from Program modes menu. Confirm by the button or once again press the selected field. Press the button from main menu. Select the sequence. Press Confirm by pressing or resign using User Manual – PhysioMG Page 38 / 58...

  • Page 39: Safe Shutdown Procedure

    7. Unit operation 7.12 Safe shutdown procedure The work flow for the safe termination of the operation: Step Description Proceed with the treatment to the end or stop it by pressing the key. In case of treatment carried out by using a CPEP type applicator, remove it from the patient. Click the UNIT ON / OFF (STANDBY) button on the front panel After clicking the button, a message will appear on the display as it is shown on the screen below.

  • Page 40: Definitions And Parameters

    The peak-to-peak value is given in relation to the maximum induction. 8.2 Treatment parameters Characteristic of treatment parameters: Symbol Definition Available parameters Solenoid CS35 Solenoid CS60 Type of applicator Solenoid CS75 Plate CP Plate CPEP Shape of magnetic field Double-half rectangular User Manual – PhysioMG Page 40 / 58...
  • Page 41 8. Definitions and parameters Symbol Definition Available parameters Double-half triangular Double-half sinusoidal Double-half pulse Single-half rectangular Single-half triangular Single-half sinusoidal Single-half pulse 2 Hz – 120 Hz with variable step (manual Solenoid adjustment possible by "holding" with the applicators pen / finger of the frequency field – in Magnetic field increments of every 0.01 Hz Figure 8.1) frequency...

  • Page 42: The Mode Of Magnetic Field Generation

    Figure 8.2. Manual time setting 8.2.1 The mode of magnetic field generation PhysioMG has two modes of magnetic field generation: continuous and intermittent. In continuous mode, the magnetic field is generated with a constant amplitude throughout the duration of the treatment.

  • Page 43: Spectrum

    8. Definitions and parameters Figure 8.4. Double-half wave 8.2.2 Spectrum The spectrum determines the frequency modulation range as a function of time. The frequency is modified symmetrically with respect to the basic frequency (Figure 8.5). Figure 8.5. Frequency spectrum Examples for solenoid applicators: Base frequency fg Minimum Maximum...

  • Page 44: Limitation Of Induction With Frequency Increase

    The higher the frequency, the lower the induction. The characteristics of induction changes measured at the reference point (geometric center of the applicator) as a function of frequency are presented below. Legend: User Manual – PhysioMG Page 44 / 58...
  • Page 45 8. Definitions and parameters Figure 8.6. Decrease in induction value with frequency increase The unit also features a mechanism to limit the induction when two applicators are operated simultaneously in two-channel controllers. The purpose of the protection is to limit the possibility of exceeding the rated parameters components affecting...

  • Page 46: Indications And Contraindications

    If the therapy is carried out on ulcerations, decubitus ulcers, burns in the phase with effusion or post- traumatic wounds in the inflammatory phase, the treated area should be protected with a sterile dressing, e.g. gauze. User Manual – PhysioMG Page 46 / 58...

  • Page 47: Possible Side Effects

    9. Indications and contraindications 9.3 Possible side effects tingling or numbness in the body parts undergoing treatment • • feeling of heat in the location of therapy • general irritability • insomnia • concentration disorders Page 47 / 58 Issue date 02.09.2019, release 10.0...

  • Page 48: Maintenance, Cleaning, Disinfection

    Perform disinfection of magnetic field applicators after each treatment procedure, where there is contact with the patient's body. It is recommended to use sanitizers based on ethanol and/or isopropyl alcohol e.g. Alpro User Manual – PhysioMG Page 48 / 58...

  • Page 49: Special Messages

    Warnings 10.5 Self-test Procedure Each time the PhysioMG unit is started, a special self-test procedure is performed during which all modules and functional blocks of the device are tested. If any errors or damage are detected, the relevant information will be presented on the display screen. The module where the irregularity has been detected is blocked and the associated function is not available.

  • Page 50: Troubleshooting

    Before proceeding to the further described operations isolate the unit from the mains supply! In case of burnt fuses, they must be replaced. Their parameters are given in chapter ”Specification and accessories” and on the name plate. User Manual – PhysioMG Page 50 / 58...
  • Page 51 10. Maintenance, cleaning, disinfection To replace fuses: Step Description Isolate the device from the mains. Disconnect the mains cable from the mains socket. With flat screwdriver lever the fuse socket until the moment of its slipping from the socket. Remove the socket with your fingers, replace the fuses, install them in the socket again and press firmly.

  • Page 52: Specification And Accessories

    29kg Carrying capacity of the couch: up to 135 kg Carrying capacity of the shelf for the unit: max. 8 kg Carrying capacity of the shelf for CPEP: max. 3 kg User Manual – PhysioMG Page 52 / 58...
  • Page 53 11. Specification and accessories Carrying capacity of the ST_CS trolley: max. 25 kg for every shelf Unit dimensions (WxDxH): 340x280x110 mm CS35 dimensions: 441x322x457 mm CS60 dimensions: Ø682x242 mm CS75 dimensions: Ø832x242 mm Dimensions of one part of the CP applicator: 200x69x150 mm Dimensions of one part of the CPEP applicator: 100x55x150 mm...

  • Page 54: Emc Parameters

    RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the PhysioMG unit is used exceeds the applicable RF compliance level above, the unit should be observed to verify normal operation.
  • Page 55 11. Specification and accessories Immunity test IEC60601 test level Compliance level Magnetic field power frequency (50/60 Hz) 30 A/m 30 A/m IEC 61000-4-8 Immunity test IEC60601 test level Compliance level 0% U 0,5 cycle, phase angles of synchronization with AC power supply voltage 0°, 45°, 90°, 135°, Complies 180°, 225°, 270°, 315°...

  • Page 56: Standard Accessories

    11. Specification and accessories 11.3 Standard accessories Quantity Name version version version PhysioMG controller (depends on A-UG-AST- A-UG-AST- A-UG-AST- model) PMG815 PMG825 PMG827 Mains cable Spare fuses WTA-T 3,15 A/250V LCD touch screen cloth Pen for LCD resistive touch screen...

  • Page 57: Appendix A. Symbol Description

    13. Appendix A 12. Appendix A. Symbol description Symbol Definition Caution, symbol 7000-0434A BF type equipment, symbol IEC 60417-5333 Date of production: year, symbol ISO 7000-2497 Temperature, symbol ISO 7000-0034 Manufacturer, symbol ISO 7000-3082 IP20 Degree of protection provided by enclosures (IP code), based on IEC 60529 Fuse, symbol IEC 60417-5016 Unit version Serial number, symbol ISO 7000-2498...
  • Page 58 Weight Packaging size The marking of conformity with legal regulations for medical devices applicable in the European Union along with the number of the Notified Body taking part in the conformity assessment. User Manual – PhysioMG Page 58 / 58...

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