gbo Medizintechnik HiToP 4 touch Instructions For Use Manual

Hightone therapy device

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HighTone Therapy Device
HiToP 4 touch
Instructions for use

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Summary of Contents for gbo Medizintechnik HiToP 4 touch

  • Page 1 HighTone Therapy Device HiToP 4 touch Instructions for use...
  • Page 2 Medizintechnik AG has taken care in the preparation of this manual, but does not assume any liability, expressed or implied, of any kind nor does it assume any responsibility for errors or omissions. All rights reserved. No part of this manual may be reproduced, in any form or by any means (electronic, mechanical or otherwise) without the prior written permission of gbo Medizintechnik AG.
  • Page 3: Table Of Contents

    5.4 Multiple longitudinal (whole-) body treatments in parallel ......25 MAINTENANCE .................... 26 6.1 Safety Controls ................... 26 6.2 Disposal of the device and the accessories ..........26 6.3 Cleaning, Disinfection and Care ..............27 6.3.1 Cleaning the Device .................. 27  gbo Medizintechnik AG Version 1.3...
  • Page 4 TROUBLESHOUTING ................36 APPENDIX ....................37 INDEX ......................40 Warnings and safety precautions Warning! Warnings which have to be observed by all means! Caution! Observe the instructions for use! Note! Information that will facilitate your work.  gbo Medizintechnik AG Version 1.3...
  • Page 5: Introduction

    4096 – 32768 Hz. The therapy frequency is scanned with a defined frequency.  This method is called SimulFAM which stands for Simultaneous Frequency Amplitude Modulation. In the following, the basic method is divided into two different ones.  gbo Medizintechnik AG Version 1.3...
  • Page 6: Short Operating Instructions For Simulfam I

    (10) Press the button “Continue” to accept the intensity at 16384 Hz. ® (11) The bar display SimulFAM i shows the frequency scan. (12) A special tone marks the end of the treatment time. (13) The current to the patient will decrease automatically.  gbo Medizintechnik AG Version 1.3...
  • Page 7: Short Operating Instructions For Simulfamx

    (7) In case of a frequency scan the current stimulation frequency is shown. The frequency values increase and decrease every second. (8) A special tone marks the end of the treatment time. (9) The current to the patient will decrease automatically.  gbo Medizintechnik AG Version 1.3...
  • Page 8: Start Of Operation

    4 touch with the mains cable to a socket with protective ground. The protective ground must work correctly.  The HiToP 4 touch is switched on by the main switch on the back of the device.  gbo Medizintechnik AG Version 1.3...
  • Page 9: Placing Out Of Operation

    Figure 1: Back view of the device stick 2.3 Placing out of operation In order to disconnect the device just disconnect it from the mains power supply. No other measures are to be taken.  gbo Medizintechnik AG Version 1.3...
  • Page 10: Operating

    Every button is clearly labeled. Optically, the user can differentiate operating buttons from non-operating buttons. In case of doubt the user can obtain further information via the direct help system.  gbo Medizintechnik AG Version 1.3...
  • Page 11: Intensity Regulator

    Note! In the event that the intensity is set to 5000 mW while turning the button, the unit initiates a counterforce to the knob to signal to the user that the limit is reached.  gbo Medizintechnik AG Version 1.3...
  • Page 12: Direct Help Menu

    Available buttons are indicated in light grey. Unavailable buttons are indicated in dark grey. If you push an unavailable button, information about the use of this button is shown on the screen automatically. direct help window Figure 3: Direct help menu as shown on the display  gbo Medizintechnik AG Version 1.3...
  • Page 13: Intensity Monitoring

    3. Generally, please observe the notice regarding the electrode positioning (see chapter 5.3). We at gbo Medizintechnik AG expanded the device software by a special intensity monitoring routine in order to get the application problems mentioned under control. This safety circuit avoids an unintended high change in the intensity of current and switches off the respective channel in such a case.
  • Page 14: Deactivate Intensity Monitoring

     The Intensity monitoring remains deactivated for a channel until it is modified manually into “on“ by pressing the button “Intensity monitoring”.  Upon each restart of the device the Intensity monitoring is automatically activated.  gbo Medizintechnik AG Version 1.3...
  • Page 15: Settings

    A new language version may be loaded. A software update may easily be installed in this sub-menu. A USB stick is used for the transfer of the data. The USB stick must be placed in the back side of the unit.  gbo Medizintechnik AG Version 1.3...
  • Page 16: Music Playback (Audio)

    “sound” a flyout will open up. Now you can switch on the tone and also the volume may be adjusted in this flyout. NOTE The activated sound is indicated by a blue bar within the button.  gbo Medizintechnik AG Version 1.3...
  • Page 17: Therapy

    (the choice is (the activated group administration selected indication highlighted in blue) is indicated by a (the choice is indicated green hook) by a blue bar) Figure 4: Touch screen with selected indication  gbo Medizintechnik AG Version 1.3...
  • Page 18: Frequently Used Therapies And Indications (Favourites)

    The user can recall typically used therapies with only one touch. Additional therapies can either be recalled according to a patient’s name, i.e. via log book, or by referring to indications or the name of the therapy.  gbo Medizintechnik AG Version 1.3...
  • Page 19: Setting Simulfam I

    Setting SimulFAM X If the current form SimulFAM X is selected, the frequencies are run through faster. The frequency run can be set between 01 Hz up to 200 Hz.  gbo Medizintechnik AG Version 1.3...
  • Page 20: Working With The Patients

    4.4.1 Compilation of new patient If you choose the button “patient“ and then the button “new“ you get to the virtual keyboard for the compilation of a new patient. Mandatory are the first name, last  gbo Medizintechnik AG Version 1.3...
  • Page 21: Load Patient File For Therapy

    The therapy conducted last may easily be applied by pressing the button “Accept all”. I.e. all therapy parameters of the last therapy are accepted.  gbo Medizintechnik AG Version 1.3...
  • Page 22: Electrodes

    Press the electrodes together. Select SimulFAM i on the device and increase the current with the intensity controller. The displayed resistance (R =) should not exceed 300 Ohm.  gbo Medizintechnik AG Version 1.3...
  • Page 23: Advise On Self Adhesive Electrodes

    Yet, the use of adhesive electrodes might be necessary for special applications (e.g.: in the face). The therapist must then take special care and monitor that the adhesive electrodes are used correctly and do not heat up.  gbo Medizintechnik AG Version 1.3...
  • Page 24: Electrode Positioning

    Otherwise, flush or even burns may show.  During the therapy the patient must take off jewelry and eyeglasses. Note!  A current density of over 2 mA/cm on all electrode surfaces requires increased attention of the operator.  gbo Medizintechnik AG Version 1.3...
  • Page 25: Multiple Longitudinal (Whole-) Body Treatments In Parallel

    This note is only applicable for current circuits overlapping in a significantly large area. As a matter of cause local therapies of small body regions, e.g. the knee, conducted during a whole-body treatment are not concerned.  gbo Medizintechnik AG Version 1.3...
  • Page 26: Maintenance

    The device must be returned to the manufacturer for disposal. The manufacturer is committed to guarantee the disposal of all devices marketed. This is also indicated by the WEEE sign (crossed out waste container).  gbo Medizintechnik AG Version 1.3...
  • Page 27: Cleaning, Disinfection And Care

    Note! The conductivity of the electrodes is optimized by the use of a certain amount of graphite. Consequently, when using and cleaning the electrodes, black color may come off.  gbo Medizintechnik AG Version 1.3...
  • Page 28: Disinfecting The Electrodes

    We recommend Bacillol-AF for the disinfection of the electrodes. Note! The conductivity of the electrodes is optimized by the use of a certain amount of graphite. Consequently, when using and disinfecting the electrodes, black color may come off.  gbo Medizintechnik AG Version 1.3...
  • Page 29: Warnings And Safety Precautions

     In case of a short circuit the lithium battery contained in the device can explode. Only service staff should change the battery.  In case of any visible failure contact gbo Medizintechnik AG or one of the service agencies authorized by gbo Medizintechnik AG immediately.
  • Page 30: Contraindications

    The above list is not exhaustive. In individual cases the attending doctor should decide on contraindications and criteria for the treatment. Note! Patients with varicose veins, metallic implants and endoprotheses may ® be treated with HiToP Therapy.  gbo Medizintechnik AG Version 1.3...
  • Page 31: Explanation Of The Pictographs Used

    This product complies with WEEE Directive 2002/96/EG (waste electrical and electronic equipment). Separate collection for electrical and electronic equipment. The waste removal at the end of the service life will be done by the manufacturer.  gbo Medizintechnik AG Version 1.3...
  • Page 32: Technical Data

    ± 10 % By request of technical personnel gbo Medizintechnik AG can offer spare part lists and circuit diagrams. The mains switch is used for all-pin disconnection from the mains power supply. The exchange of the battery is described in the service manual.
  • Page 33: Current Types

    The maximum power per channel is limited to 5000 mW. This correlates with the demands of the standard 60601-2-10 which describes a limitation of 100 mA at 500 . The valid impedance ranges from 30  to 1500 .  gbo Medizintechnik AG Version 1.3...
  • Page 34: Accessories

    For detailed information see the enclosed brochure “HiToP 4 touch and Accessories”. This brochure is also available as a pdf-file by download on our website: www.gbo-med.de. Note! Use gbo original accessories only to guarantee the safe function of the unit.  gbo Medizintechnik AG Version 1.3...
  • Page 35 4 touch, following additional accessories are available: specification part number  026-0-3000 device cart for HiToP touch Tray for electrodes and cables 026-0-2020  027-0-1000 bed for HiToP touch Figure 7:  HiToP 4 touch with accessories, device cart and  gbo Medizintechnik AG Version 1.3...
  • Page 36: Troubleshouting

    Please note that the unit must be placed on a plane horizontal surface. The device should neither be placed in front of radiators nor should it be covered with pillows or blankets while in operation. Do not cover the ventilation slots on the bottom of the unit either.  gbo Medizintechnik AG Version 1.3...
  • Page 37: Appendix

    You find more EMC-comments in the chapter “Warnings and Safety Precautions” of this manual as well as the Technical Information on the next two pages.  gbo Medizintechnik AG Version 1.3...
  • Page 38 Power frequency magnetic fields should be magnetic field, at levels characteristic of a typical location IEC 61000-4-8 in a typical commercial or hospital environment. Note: U is the a.c. mains voltage prior to application of the test level.   gbo Medizintechnik AG Version 1.3...
  • Page 39 Separation distance according to the transmission frequency (m) transmitter (W) 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz d=1.2P d=1.2P d=2.3P 0.01 0.12 0.12 0.23 0.38 0.38 0.73  gbo Medizintechnik AG Version 1.3...
  • Page 40: Index

    Switch-On 8 Electrode positioning 24 Technical Data 32 Electrodes 22, 27 Therapy 17 Touch screen 10 Transport and Assembly 8 Troubleshouting 36 Intended Use 5 Intensity regulator 11 Warning 24 warnings 8, 29 Maintenance 26  gbo Medizintechnik AG Version 1.3...
  • Page 41 Notes  gbo Medizintechnik AG Version 1.3...
  • Page 42 Notes  gbo Medizintechnik AG Version 1.3...

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