Gymna ShockMaster 300 User Manual
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Gymna ShockMaster 300 User Manual

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USER MANUAL
ShockMaster 500 & ShockMaster 300
0344

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Summary of Contents for Gymna ShockMaster 300

  • Page 1 é USER MANUAL ShockMaster 500 & ShockMaster 300 0344...
  • Page 3 Unauthorised reproduction, either in whole or part, of the software provided with this product is strictly prohibited and is subject to prosecution. All rights reserved. Manufacturer: GymnaUniphy N.V. Pasweg 6A 3740 Bilzen Belgium T +32 (0) 89 510.510 F +32 (0) 89 510.511 info@gymna.com www.gymna.com Version 412 of 2018-04-16...

  • Page 4: Table Of Contents

    1.3.2 Training of the operator ................... 9 1.4 Description of controls and functional elements ShockMaster 500 ......10 1.5 Description of controls and functional elements ShockMaster 300 ......12 General safety information .................. 14 Installation......................18 3.1 Unpacking ......................18 3.2 Scope of delivery ....................
  • Page 5 5.3.1.2 Total amount of shocks ................33 5.3.1.3 Frequency ....................33 5.3.1.4 Overview parameter properties ..............33 5.3.1.5 Actual number of shocks ................33 5.3.2 Behavior of the hand piece control: ..............34 5.3.3 Parameter increase/decrease behavior: ............34 5.4 Applications Menu ....................34 5.4.1 Library ......................
  • Page 6 8.5 Documentation ....................76 Technical specifications ..................77 9.1 Technical data of ShockMaster 500 ............... 77 9.2 Technical data of ShockMaster 300 ............... 77 9.3 Conformity with directives ................... 78 9.4 Conformity with standards ................... 78 9.5 EMC guidance and manufacturer’s declaration ............79 10 Warranty and service ..................

  • Page 7: General Information

    General Information Introduction This manual contains warnings, safety instructions and specific operating instructions in accordance with liability regulations. CAUTION Complete or partial failure to observe the instructions, information or procedures preceded by the term “CAUTION” may cause injury or fatal accidents. ATTENTION Complete or partial failure to observe the instructions, information or procedures preceded by the term “ATTENTION”...

  • Page 8: Intended Use

    CAUTION Before you start using the ShockMaster 500 or ShockMaster 300 for the first time, please make sure you have read and understood all information provided in this operating manual. Familiarity with the information and instructions contained in this manual is an essential requirement to ensure efficient and optimal use of the device, to avoid dangers to persons and to the equipment and to obtain good treatment results.

  • Page 9: Applications

    NOTE Medical devices operating on the basis of the above principle are generally referred to as extracorporeal shockwave devices in modern medical literature. 1.2.1 Applications The ShockMaster is designed for extracorporeal treatment by means of low- to medium-energy radial shockwaves in the following fields of application: ...

  • Page 10: Side Effects

     large nerves and vessel cavities that contain air (lung, intestines, …)  risk of haemorrhaging  cardiac region  open scar  vertebrae, spinal column or head 1.2.3 Side effects Treatment with the ShockMaster may cause the following side effects: ...

  • Page 11: Training Of The Operator

    Further information about training in the operation of this device can be obtained from your GymnaUniphy dealer. However, you can also contact the following address directly: GymnaUniphy NV Pasweg 6A 3740 Bilzen Belgium Tel.: +32 (0) 89 510 510 Fax: +32 (0) 89 510 511 info@gymna.com Version 412 of 2018-04-16...

  • Page 12: Description Of Controls And Functional Elements Shockmaster 500

    Description controls functional elements ShockMaster 500 LCD TFT Touch Screen R-SW Handpiece 1. Connector R-SW/V-ACTOR handpiece channel black 2. Connector R-SW/V-ACTOR handpiece channel yellow Version 412 of 2018-04-16...
  • Page 13 1. USB connector (type A) 2. Compressed air inlet 3. Auxiliary power outlet for the compressor 4. Mains supply inlet 5. Mains fuses holder 6. Mains switch 7. Sign “Consult and observe the instructions for use” NOTE The USB connection is only suitable for connecting a USB memory stick that supports the USB V1.1 protocol.

  • Page 14: Description Of Controls And Functional Elements Shockmaster 300

    Description controls functional elements ShockMaster 300 1. LCD TFT Touch Screen 2. Connector R-SW/V-ACTOR hand piece 3. V-ACTOR II Version 412 of 2018-04-16...
  • Page 15 1. USB connector (Type A) 2. Pressure filter housing 3. Read the manual first 4. Mains power inlet 5. Mains fuse holder 6. Mains switch NOTE The USB connection is only suitable for connecting a USB memory stick that supports the USB V1.1 protocol.

  • Page 16: General Safety Information

    General safety information CAUTION The ShockMaster is exclusively intended for use by medical specialists and must only be used by suitably qualified and trained medical personnel (see also section 1.3 Prerequisites for operating the ShockMaster ) The user is responsible for correctly positioning the hand piece of the ShockMaster and determining where the treatment zone of the patient is located.
  • Page 17 ATTENTION Check that the installation surfaces have sufficient carrying capacity to avoid equipment damage! Medical electrical devices are subject to special regulations regarding electromagnetic compatibility (EMC). Hence, medical electrical devices must be installed and commissioned in accordance with the EMC guidelines detailed in section 9.5 EMC guidance and manufacturer’s declaration.
  • Page 18 NOTE ShockMaster meets requirements applicable electromagnetic compatibility (EMC) standards IEC / EN 60601-1-2. These limits are designed to provide reasonable protection against harmful interference in a typical medical installation. The equipment generates, uses and can radiate radio frequency energy. If not installed and used in accordance with these instructions, the equipment may cause harmful interference to other devices in the vicinity.
  • Page 19 ATTENTION Before the ShockMaster can be cleaned and disinfected, the device must be switched off and must be separated from the supply mains (see above). The ShockMaster 500 and accessories must be initially cleaned and disinfected prior to entry into service as well as before each use. While performing cleaning...

  • Page 20: Installation

    Installation ATTENTION The ShockMaster device shall be installed only by qualified and authorized personnel with sufficient knowledge of the medical application and who have been instructed accordingly in the handling of the device. Unpacking  Remove the equipment and accessories from the packaging container. Proceed with extreme caution ...

  • Page 21: Shockmaster300

    Tissue Box  Protective Anti-Skid mat  User manual of the ShockMaster 300 (hard copy in English, other languages available on  User manual of the hand piece (hard copy in English, other languages available on CD)  Safety Manual (CD-rom) Please refer to chapter 7 for information on ACCESSORIES AND SPARE PARTS.

  • Page 22: Device Installation

    Device Installation CAUTION Carefully follow the instruction guideline for the device installation step by step. 3.4.1 Compressor Installation ShockMaster500 Preparation Fig. 1 Remove red cap (transport protection) Fig. 2 Assemble air filter Fig. 3 Connect air hose if it is separately supplied Version 412 of 2018-04-16...
  • Page 23 Fig. 4 Turn the tap in the open position (in line with the air flow). Fig. 5 Turn the start switch to position “1” Trolley bay for the compressor Fig. 6 Open the front door of the trolley Version 412 of 2018-04-16...
  • Page 24 Fig. 7 Place the compressor into the trolley (as in the picture) Fig. 8 Insert the compressor mains plug into the socket of the trolley Fig. 9 Place the air hose and power cord on top of the trolley, as in the picture, and insert the cable into the clamp.

  • Page 25: Connections At The Rear Of The Control Unit

    After connecting the compressor and the control unit (chapter 3.4.2), switch on the device and check both manometers of the compressor: Fig 10 Check Manometer on left hand side: should have a pressure of +/- 8 bar. This pressure reflects the pressure inside the tank.

  • Page 26: Shockmaster300

    NOTE The compressor is automatically switched on and off by the ShockMaster 500. During installation make sure that the mains switch of the compressor is in the ON position. 1. Press the air hose coupler firmly into the air inlet socket until it locks with an audible click.

  • Page 27: Hand Piece Connection

    ATTENTION When setting up the instrument, make sure that the air outlets on the housing of the ShockMaster 300 is not blocked. The instrument must only be connected to properly installed and grounded wall outlets. 3.4.3 Hand piece connection ...
  • Page 28  Ensure the red spot on the connector match the red spots on the hand piece or V-ACTOR connector.  Place the handpiece in the handpiece holder.  The V-ACTOR has a specific V-actor holder, delivered separately. NOTE Please refer to the separate operating instructions of the R-SW Handpieces and V-ACTOR SHOCKMASTER300 SHOCKMASTER500 1.

  • Page 29: Operation

    Operation Functional check Perform the following functional checks after the system has been installed:  Check the control unit and hand pieces for damage.  Switch on the ShockMaster  Set the energy level to 1.5 bar and frequency 5 Hz. ...

  • Page 30: Treatment

     Start the R-SW treatment at a pressure of 1.5 bar and a frequency of 8 Hz.  Please read chapter 5 (the user interface) for more information about the settings. Treatment CAUTION Always read chapter 2 General safety information before starting a treatment. Please refer to the separate operating instructions for the hand piece.

  • Page 31: The User Interface

    The user interface NOTE All following representations of menus are examples and no treatment proposals Introduction The Shockmaster software contains a treatment screen (=main menu), an application screen (containing submenus) and system buttons:  Treatment screen Pressure Number of shocks Frequency Actual number of shocks ...

  • Page 32: Home Screen

    Home Screen Home screen SHOCKMASTER500: System buttons Application Treatment screen screen Home screenSHOCKMASTER300: System buttons Treatment Application screen screen Version 412 of 2018-04-16...

  • Page 33: Treatment Menu

    Treatment menu Current value Increase Decrease Enable/disable of parameter. corresponding corresponding pressure soft- parameter. parameter. start option Reset the actual Actual number number shocks with shocks. progression bar. The “treatment menu” is the main menu that displays after the device is powered on. In this menu the pressure, amount of shocks and shock frequency can be adjusted by the user.
  • Page 34 the maximum pressure depends on the adjusted frequency used. Below 21Hz the pressure can be adjusted from 1 – 4 bars. Above 21Hz the maximum pressure is as displayed in the table below: Frequency Max. pressure 21 Hz 4 bar 22 Hz 3.9 bar 23 Hz...

  • Page 35: Total Amount Of Shocks

    1 – 5 0.3 – 5 1 – 5 Unit of pressure Frequency 0.5Hz – 21Hz 0.5Hz – 21Hz 0.5Hz – 35Hz SHOCKMASTER 300: R-SW Handpiece R-SW Handpiece Short V-ACTOR Pressure 1 – 4 0.3 – 4 1 – 4...

  • Page 36: Behavior Of The Hand Piece Control

    If the user pressed this button by accident, the amount of shocks would be lost before it was saved. Below the “Actual number of shocks”, a progress bar is displayed to indicate how many % of the “Total number of shocks” is already given. The progress bar consists out of 20 segments, so 1 segment represents 5%.

  • Page 37: Library

     Neurological applications  Custom applications (NOT AVAILABLE FOR SHOCKMASTER300) The difference between the “Library” option and all other Applications buttons is that the “Library” option will display a complete list with all types of Applications, while the rest of the application buttons activate the same menu (Library) but with different filter settings.

  • Page 38: New Application (Not Available For Shockmaster300)

    On the right side of the screen the user can select the following option: New application (= custom application) (NOT AVAILABLE FOR SHOCKMASTER300) Load the selected application (Also possible by double clicking the selected application) Information about the selected application Edit application (NOT AVAILABLE FOR SHOCKMASTER300) Delete application (NOT AVAILABLE FOR SHOCKMASTER300) In the top bar of the screen, following options are available from left to right:...
  • Page 39 With the “+” symbol, a new sequence will be added. With the “x” symbol, the corresponding tab page (sequence) will be removed. The user can add maximum 5 sequences to his custom application. In the 3 input screen, some extra remarks about the Application can be entered. All data can be entered with the keyboard displayed in the lower part of the screen In order to enter accents, capital letters, numbers and special characters, the user can select different tabs.

  • Page 40: Load Application

    If there is already an Application with this name, a popup will be displayed if the user wants to confirm. If a “Custom” Application is created, it will be added to the list of Applications. A purple dot is displayed in front, in order to indicate that it is a “custom” Application. 5.4.1.2 Load Application This function is also activated by double clicking the selected application...
  • Page 41 If one decides NOT to use the patient Guided Therapy System by pushing “X”, the treatment screen will appear with the parameter settings, according to the Library, for all sequences. If the user decides to use the pGTS by pushing “V”, the VAS score will be used to determine the parameter settings.
  • Page 42 Each sequence can contain more than 1 treatment picture. By pushing this picture, the next one will be displayed. The blue rectangles at the bottom of the picture indicate how many sequence pictures are available, and which one is currently displayed. The same principle is used for the preferred and/or alternative applicator(s).
  • Page 43 Application Previous Home Next Current Name sequence button sequence sequence name Current sequence parameters Current Sequence Number Picture and name of preferred applicator. treatment treatment picture Number of alternative applicator(s) picture(s) that is displayed c) Restrictions Each sequence is compatible with a specific handpiece or V-actor and correlated parameter properties.

  • Page 44: Application Info

    Sequence Situation B Action 1: trigger button of V-actor is pushed Action2: trigger button of Standard handpiece is pushed Reaction: NO shocks are released and a pop-up should appear: “please connect the short handpiece for this application” Sequence Situation C Action 1: trigger button of Standard Handpiece is pushed Action 2: trigger button of Short Handpiece is pushed Reaction: NO shocks are released+ pop up: “please connect the V-actor for this...

  • Page 45: Edit Application (Not Available For Shockmaster300)

    Example: Custom Applications contain only 2 info screens. The first screen is a list of the containing sequences (max. 5) with their parameters. The second screen shows the remarks. 5.4.1.4 Edit Application (NOT AVAILABLE FOR SHOCKMASTER300) The “Edit” Application menu has the same look and feel as a “New application” but with all the Application data of the selected Application filled in.

  • Page 46: Delete Application (Not Available For Shockmaster300)

    5.4.1.5 Delete Application (NOT AVAILABLE FOR SHOCKMASTER300) Only “Custom” Applications can be deleted. The following popup will be displayed. The user must now confirm the “delete” action. After confirming, the user will be asked if the Application must be archived for future use. When he does not confirm then the Application will be permanently deleted and cannot be recovered.

  • Page 47: Filter Applications List

    5.4.1.7 Filter Applications list In order to find a certain type of Application more quickly, it is possible to show/hide every type of Application. You can select a filtered list by selecting the specific type of Application in the main menu (see page 4 and 6) or via the filter panel in the Application menu.

  • Page 48: Search Application

    5.4.1.8 Search Application When the list is very long, the user can use the “Search” function in order to jump in the list to the Application that he is looking for. The search panel is displayed when the user pushes the magnifier symbol. When the user types for example the following string: “Gre”...

  • Page 49: Patients Menu (Not Available For Shockmaster300)

     Thigh  Knee  Once a body area is selected, a popup with the filtered Application list appears. By pushing the “OK” button, the selected Application will be loaded. 5.4.3 Patients menu (NOT AVAILABLE FOR SHOCKMASTER300) It is possible to make a list of patients in this menu. The look and feel and behavior is similar to the Applications menu Version 412 of 2018-04-16...

  • Page 50: New/Edit Patient

    5.4.3.1 New/Edit Patient The user can create patients in the patient-database After selecting New patient, the following screen is displayed. The first screen shows the input box for the following items: First name and last name of the Patient Birthday Telephone number The button in the upper right corner brings the user to the next input screen.

  • Page 51: Patient Info

    confirm. If a new Patient is created, it will be added to the list of Patients. The patients list is displayed: Last name – First name in alphabetical order. The “Edit” Patient screen has the same look and feel but with all the data of the selected patient filled in.
  • Page 52 Screen 3: List of Applications that have been used to treat the patient in the past. Selecting one of the applications in the list enables the 2 extra screens/tabs: Treatment and VAS score. These tabs provide more detailed information about the selected Application in screen 3.

  • Page 53: Load Patient

    Screen 4: an overview of the different treatments is shown, including treatment date and hour and the VAS score The user can select a particular treatment (executed on a particular date) More info about that treatment (executed sequences with their parameters) will now be displayed in the next screen.
  • Page 54 This popup contains at least 3 fixed choices: Select Application from List  Select Application from Body Area  Free Application  If the patient already received (a) treatment(s) in the past, the corresponding Application(s) will also be displayed in this list (black font). If the user selects one of these Applications, the Application gets loaded with the parameters that correspond to the last treatment with this Application for that patient.
  • Page 55 The arrow in left bottom corner will get you back to the previous screen. When loading an application, the pGTS will be activated (see 5.4.1.2 a) c) Free Application No extra menu will be entered; the software will go immediately to the treatment screen. The behavior of the software during a treatment is now different from a normal selected Application.
  • Page 56 screen – VAS Score: The user must now enter the VAS-score before he can continue. In this screen, the handpiece buttons are disabled, so a treatment cannot be started yet. screen: Situation 1  Application is loaded  The first sequence of the loaded Application is now visible. The Handpiece buttons are enabled, and the treatment can be started.
  • Page 57 Fixed Application Custom Application Situation 2  Free Application is selected  The first sequence is initialized with the parameter set to their default values. The user can now change these parameters including the applicator type and start the sequence. If a Fascia or Spine applicator is selected, the maximum pressure is 3bar only the short handpiece can be used.

  • Page 58: Delete Patient

    Pressing confirm does not save data, pressing cancel returns to previous treatment screen Save: The user must now confirm that the treatment data must be saved. This data will be saved under the loaded patient: Loaded Application (Name + body side) Vas score All finished sequenced used pressure...

  • Page 59: Search Patient

    After confirming, the user will be asked if the patient must be archived for future use. When he selects the cancel button, the patient will be permanently deleted and cannot be recovered. 5.4.3.5 Search Patient If the list is very long, the user can use the “Search” function in order to jump to the patient he is looking for in the list.

  • Page 60: System Buttons

    System Buttons 5.5.1 Help & Info Menu The info menu is found in the right top corner of the home screen and contains a collection of 4 submenus. Treatment information Applicators  Application  Settings parameters  Medical information (additional info about the Applications from the Application list) Anatomical library Contra Applications (plain text) 5.5.1.1...

  • Page 61: Anatomical Library (Not Available For Shockmaster300)

    Selecting an item from the application list opens the detailed information screen. 5.5.1.3 Anatomical library (NOT AVAILABLE FOR SHOCKMASTER300) Selecting a spot on the body area, will open an overview of all available anatomical structures. Selecting an item opens the detailed information screen. Version 412 of 2018-04-16...

  • Page 62: Contra Indication

    5.5.1.4 Contra Indication SHOCKMASTER500: SHOCKMASTER300: 5.5.2 Settings menu The settings screen is found in the right top corner of the home screen, next to the info button and is split up in 2 parts. In the left part, the list with settings is displayed; in the right part all parameters of the selected setting are displayed.

  • Page 63: Language

    Main HW Code: (Hardware version “unification PCB”, 4 characters) Main SN: (serial number”) The last 3 lines will only be displayed when the device has a unification PCB. 5.5.2.3 Language When the language is changed, its effect should be immediately visible. Anatomical information will always be displayed in English.

  • Page 64: Time

    5.5.2.4 Time The current Date/Time can be changed here. Any change is taken into effect immediately. 5.5.2.5 Handpiece counter (ONLY 1 HANDPIECE COUNTER AVAILABLE SHOCKMASTER300) The amount of shocks produced with a handpiece on the black or yellow output is saved here.

  • Page 65: Import/Export Patient Database (Not Available For Shockmaster300)

    If the counter reaches 1.250.000 shocks, a pop-up appears the next time the device is switched on. It displays a message warning you a revision might be needed. The pop-up has two buttons: Cancel button: Normal processing resumes. The pop-up will reappear the next time you switch on the device.”...

  • Page 66: Soft Start

    purposes. When the user pushes the export button, an icon appears next to the export button: Export action successfully executed Export action failed The complete set of exported patient data can be imported again. When the user pushes the import button, the software warns the user that the current internal set of patient data will be overwritten.

  • Page 67: Software Update

    5.5.3 Software update ATTENTION Do not connect the USB connector with other USB stick as specified or via USB cable to any other IT device such as PC or external drives to avoid electrical safety related hazards. Software updates may only take place only when no patient is being treated.

  • Page 68: Cleaning, Maintenance, Disposal, Repair

    Cleaning, Maintenance, Disposal, Repair Cleaning Regular cleaning of the system ensures perfect hygiene and safe operation of the ShockMaster CAUTION Disconnect the unit and the accessories from the mains before starting any cleaning and overhauling work! 6.1.1 Cleaning the SHOCKMASTER main unit and SHOCKMASTER500 trolley ...
  • Page 69 ATTENTION Use of incorrect cleaners can result in optical impairment of touch panel and/or damage to functionality  Cleaner must be neither acid nor alkali (neutral pH)  Do not use abrasive cleaners.  Do not use organic chemicals such as paint thinner, acetone, toluene, xylene, propyl or isopropyl alcohol, or kerosene.

  • Page 70: General Maintenance

    The conditions and limits apply in accordance to IEC 62353 (EN 62353). NOTE The ShockMaster 300 control unit is safety tested by the manufacturer conform IEC 60601-1 (EN 60601-1) and supplied with a completed test report according to IEC 62353 (EN 62353).

  • Page 71: Maintenance Shockmaster500

     Earth leakage current test in accordance with national regulations.  Earth impedance test (incl. applicator housing and with mains cable) in accordance with national regulations. Maintenance SHOCKMASTER500 6.3.1 Emptying the bottle with condensation water Fig. 15 Open the bottle (with rotary lock) and pull it out of the holder ATTENTION Please contact the service department of your local dealer if the bottle does not...

  • Page 72: Checking The Oil Level Of The Compressor

    6.3.2 Checking the oil level of the compressor Fig. 17 The oil level is shown by the glass at the backside of the „Trolley“ The oil level should be in the middle of the glass. If necessary increase the oil level by replenishing the oil tank via the ‘OIL’...

  • Page 73: Decommissioning And Disposal

    Pasweg 6A 3740 Bilzen, Belgium T +32(0)89 510.510 F +32(0)89 510.511 info@gymna.com www.gymna.com Expected life time The average expected service life is approximately 10 years for the ShockMaster. For information about the service life of your hand piece, please refer to the separate operating manual for your hand piece.

  • Page 74: Status Messages And Trouble Shooting

    Exceeding the service life can result in a failure of the instrument and accessories. This also applies to handpieces. In this case, no warranty claims shall be accepted on the basis of the information given in chapter 8. Status messages and trouble shooting Status messages Restart the system.
  • Page 75 Fault description Possible cause Corrective actions Red tap on the air tanks outlet Turn the tap in the open position is in closed position (in line with the air flow). Compressor main switch in OFF Switch ON the compressor. position. Compressed tube Check air tube connections at the...

  • Page 76: Accessories And Spare Parts

    The ShockMaster 500 has to be used in conjunction with intended components / accessories. For information on the operation of the R-SW handpieces, applicators and V- Actor as well as compressor component please refer to the attached separate operation manuals. ShockMaster 300 Power cords  Power cord with CEE 7/7 plug (Europe) ...

  • Page 77: Accessories

    NOTE The ShockMaster 300 has to be used in conjunction with intended components / accessories. For information on the operation of the R-SW handpieces, applicators and V- Actor please refer to the attached separate operation manuals.  Accessories Standard: R-SW hand piece Short (1 metal projectile + tube included)

  • Page 78: Documentation

    Documentation User manual ShockMaster Safety Manual ShockMaster Accessory Manual R-SW Handpiece Safety Manual R-SW Handpiece Accessory Manual V-ACTOR® Handpiece (optional) User manual compressor (only SHOCKMASTER500) Version 412 of 2018-04-16...

  • Page 79: Technical Specifications

     Classification in accordance with MDD 93/42/EEC:  Electrical protection class:  Applied part type: Technical data of ShockMaster 300 • Operating mode R-SW R-SW: single shock, 0.5 - 17 Hz ® V-ACTOR : single shock, 0.5 - 31 Hz •...

  • Page 80: Conformity With Directives

    IPX1 Conformity with directives The ShockMaster 500 and ShockMaster 300 both comply with the requirements of directive 93/42/EEC on medical devices (MDD), directive 2011/65/EU on the restriction of the use of certain hazardous substances in electrical and electronic equipment (RoHS2) and directive 2002/96/EC on waste electrical and electronic equipment (WEEE).

  • Page 81: Emc Guidance And Manufacturer's Declaration

    EMC guidance and manufacturer’s declaration Guidance and manufacturer’s declaration – electromagnetic emissions The model ShockMaster is intended to be used in the electromagnetic environment specified below. The customer or the user of the ShockMaster should assure that it is used in such an environment.
  • Page 82 Guidance and manufacturer’s declaration – electromagnetic immunity The model ShockMaster is intended to be used in the electromagnetic environment specified below. The customer or the user of the ShockMaster should assure that it is used in such an environment. Electromagnetic Immunity test IEC 60601 test level Compliance level...
  • Page 83 Guidance and manufacturer’s declaration - electromagnetic immunity The model ShockMaster is intended to be used in the electromagnetic environment specified below. The customer or the user of the ShockMaster should assure that it is used in such an environment. Electromagnetic Immunity test IEC 60601 test level Compliance level...
  • Page 84 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. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy.
  • Page 85 Recommended separation distances between portable mobile communications equipment and the ShockMaster 500 The ShockMaster 500 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the ShockMaster 500 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the ShockMaster 500 as recommended below, according to the maximum output power of the communications equipment.

  • Page 86: Warranty And Service

    Warranty and service 10.1 Warranty GymnaUniphy and the local GymnaUniphy dealer declares itself to be solely responsible for the correct operation when: • all repairs, modifications, extensions or adjustments are performed by authorised people; • the electrical installation of the relevant area meets the applicable legal regulations; •...

  • Page 87: Attachment

    Attachment Symbol Meaning Manufacturer YYYY-MM Date of manufacturing and country of origin (Slovakia) 0344 CE mark with identification number of the notified body Serial number Do not dispose of this electrical equipment in domestic waste! Attention Applied part type B Consult and observe the instructions for use (manual) Maximum mass of the safe working load (Trolley) Maximum mass of drawer load (Trolley)
  • Page 88 GymnaUniphy NV Pasweg 6A | B-3740 Bilzen, Belgium Tel: +32 (0)89 510 510 | Fax: +32 (0)89 510 511...
  • Page 89 Version 412 of 2018-04-16...
  • Page 90 Tel.: 0032-89-510510 Fax: 0032-89-510511 e-mail: info@gymna.com Recurrent testing according to EN 62353 Technical safety inspection by the user (MDD Annex 1, 13.6.d) EN 62353 (IEC 62353, VDE 0751-1) Recurrent test and test after repair of medical electrical equipment. shockwave therapy device...

This manual is also suitable for:

Shockmaster 500

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