EMS Physio EMS360 User Manual
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EMS Physio EMS360 User Manual

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User Manual
EMS360/460
PRIMO THERASONIC
Model 121/120
1639

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Summary of Contents for EMS Physio EMS360

  • Page 1 User Manual EMS360/460 PRIMO THERASONIC Model 121/120 1639...
  • Page 2 OM360/460 Iss 15...

  • Page 3: Table Of Contents

    Contents Page Contents General information & record of amendments Warranty statement Introduction & indications for use Contraindications Accessories Controls and markings Installation Operating instructions Maintenance Appendix A - Overview of treatment modality Appendix B – Technical specification Appendix C - EMC table OM360/460 Iss 15...

  • Page 4: General Information & Record Of Amendments

    These instructions must be studied before putting the unit into operation. The information contained in this manual is subject to change without notice. No part of this manual may be photocopied, reproduced or translated into another language without the prior written consent of EMS Physio Ltd. Record of Amendments ISSUE...

  • Page 5: Warranty Statement

    Warranty This EMS Physio Ltd., (hereinafter called the Company) product is warranted against defects in materials and workmanship for a period of two years from the date of shipment. The Company will at its option, repair or replace components which prove to be defective during the warranty period, provided that the repairs or replacements are carried out by the Company or its approved agents.

  • Page 6: Introduction & Indications For Use

    Introduction The Primo Therasonic 360 provides 1MHz ultrasound therapy and the 460 provides both 1MHz and 3MHz ultrasound therapy. The units may be powered from a (specific) desktop mains to DC PSU or from a suitable external DC power bank. Indications for use Therapeutic ultrasound may be applied to a wide range of conditions with successful outcomes.
  • Page 7 Cleaning: Proper cleaning of the transducers and main unit is required. For cleaning instructions, refer to the Maintenance chapter of this manual Modification of the EMS360/460 is not permitted and may result in a hazardous situation. *Transducer temperatures exceeding 42°C will trigger an audible and visible alarm and will reduce the ultrasound output power until the transducer has cooled down.

  • Page 8: Contraindications

    Contraindications Tumours, as ultrasound affects tissue repair and could therefore encourage growth. Infections, due to the risk of spreading the infection. Pregnancy, treatment over the pregnant uterus as ultrasound could affect rapidly dividing cells. Radiotherapy, sites that have received radiotherapy treatment during the last six months.

  • Page 9: Accessories

    European mains lead 6-119 North America mains lead For other countries contact EMS Physio Ltd. (contact details on page 24) or the agent from whom the unit was purchased. WARNING: Use of accessories such as transducers, electrodes or mains cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.

  • Page 10: Controls And Markings

    Controls and Markings Therasonic 360 or 460 Top TFT display with touchscreen symbol 848-01-26 variability in steps Output control knob Cradle for ultrasound transducer On/off button OM360/460 Iss 15...
  • Page 11 Therasonic 360 or 460 Front Label Ultrasound output socket IEC symbol ISO symbol 878-01-37 IEC symbol 348 IEC symbol 7010-M002, Output Attention, consult 878-02-03 Type consult accompanying BF equipment instructions for documents The output socket is for connection of the ultrasound transducer OM360/460 Iss 15...
  • Page 12 Therasonic 360 or 460 Underside Label ISO symbol 7010- M002, consult IEC symbol 348 Serial number instructions for Name and Attention, consult and date of address of accompanying manufacture manufacturer documents Do not dispose of as unsorted waste (2006/96/EC WEEE Directive) Description Model number of ultrasound...
  • Page 13 Large Transducer Treatment light Active face Small Transducer Treatment light Active face The ultrasound transducers are calibrated independently from the Primo Therasonic 360/460 and are fully interchangeable. OM360/460 Iss 15...

  • Page 14: Installation

    The Primo Therasonic 360 or 460 operates at 18V and must only be used with an EMS Physio SLA9000 power supply (as supplied with the unit) which is connected to a mains supply of 100-240V ac. A power cord appropriately rated/approved for the country of use must be used.
  • Page 15 Essential Performance BSEN 60601-1 defines Essential Performance as: “Performance necessary to achieve freedom from unacceptable risk” Functions of the EMS360/460, the absence or degradation of which could result in a hazardous situation are: • Maximum ultrasound intensity 3W/cm • Maximum treatment time 30 minutes Loss or degradation of these functions due to EM disturbances (eg.

  • Page 16: Operating Instructions

    Operating Instructions Power On Sequence and General Information After the Primo Therasonic 360/460 is turned on a splash screen appears showing the EMS company logo along with the model name, its serial number and the installed software version. After a few seconds the unit will give a short beep and display the Home screen.
  • Page 17 Standard User Controls Throughout the operation of the Therasonic 360/460 the various modes and parameter settings are all accessed and changed by touching the relevant buttons displayed on the touchscreen. The rotary control is used to increase and decrease the ultrasound intensity when the display is showing the ultrasound screen.
  • Page 18 70% v/v aqueous solution of isopropyl alcohol. Sterile alcohol wipes are suitable for this purpose. Apply sufficient coupling medium to the area to be treated, EMS Physio Therasonic coupling medium is recommended.
  • Page 19 Always keep the face of the transducer in contact with the treatment area and always keep the transducer moving to avoid any standing waves. If the transducer face is lifted from the treatment site or if for any reason there is insufficient contact between the transducer and the treatment site for more than two seconds, the power applied to the transducer will be reduced to a low level.
  • Page 20 Protocol Treatments Touching the ‘Protocols’ button in the ultrasound set-up screen will open a screen with a scrollable list of clinical conditions and front/back human body image. Touching different parts of the body will select a list of conditions specific to that body area. Touching the highlighted condition in the list will open a user screen with the treatment parameters set for treating that condition.
  • Page 21 User Programs The Therasonic 360/460 can store up to 16 user defined set-ups. To access them touch the ‘User programs’ button either on the main home screen or in the top right corner of the ultrasound set-up screen. A screen will appear with a scrollable list of program slots – the active one is highlighted in the middle.
  • Page 22 Ultrasound Dose Algorithm This is selected by touching the Dose algorithm button in the Ultrasound set- up screen. The data concerning the state of the area to be treated is chosen by stepping through the various button options. Once the relevant parameters have been entered touching Select will open a user screen loaded with the calculated treatment settings.
  • Page 23 System Settings Menu Touching the System settings button at the bottom of the Home screen takes you to the system settings screen. The ‘Display’ button takes you to a screen where you can adjust the display brightness using up/down buttons. The ‘Sound’...

  • Page 24: Maintenance

    Maintenance The ultrasound transducers may be disinfected using a 70% v/v aqueous solution of isopropyl alcohol. They are NOT suitable for steam sterilisation or for disinfectants containing sodium hypochlorite. N.B. Isopropyl alcohol is flammable and should be kept away from naked flames.

  • Page 25: Appendix A - Overview Of Treatment Modality

    Appendix A – Overview Of Treatment Modality Ultrasound Sound is a mechanical vibration. The human ear responds to these vibrations in the range 20 Hz to 20 kHz. Sound above 20 kHz is called ultrasound. Therapeutic ultrasound is sound in the range 500 kHz to 5 MHz. Sound waves are produced by some disturbance in a material medium causing the particles or molecules of the medium to vibrate.
  • Page 26 Sound will travel faster through media where the molecules are closer together and so the velocity is higher in solids than in liquids, and higher in liquids than in gasses. For example, the velocity of sound in stainless steel is approximately 5800 m/s, in water 1500 m/s and in air only 330 m/s. As the sound wave passes through the medium, causing molecules to vibrate, some of the energy in the wave is converted from kinetic energy to heat.

  • Page 27: Appendix B - Technical Specification

    Appendix B - Technical Specification General Power input (SLA9000) 100-240V ac 1.5A 50-60Hz (EMS360/460) 18V, 3.33A (from external PSU SLA9000) Classification (EN60601-1) Class 1, Type BF Fuse Internal T3.15A Size (h x w x d) 108 x 237 x 333 mm Weight 1.3 kg...
  • Page 28 Pulse Duty Temporal peak Mode Frequency Time Cycle to average ratio 250 Hz 2 ms 166 Hz 4 ms 125 Hz 6 ms 100 Hz 8 ms 50 Hz 18 ms 10:1 The pulse width is fixed at 2 ms Output Display The Primo Therasonic 360/460 display shows the temporal-peak spatial- average ultrasound intensity and optionally the temporal-average power or...

  • Page 29: Appendix C - Emc Table

    Appendix C - EMC Test Levels. Class/Group/Immunity Test standard Description test level CISPR11:2009+A1:2010 Radiated emissions Class A Group 1 Conducted CISPR11:2009+A1:2010 Class A Group 1 emissions Immunity from IEC/EN 61000-4-2 electrostatic ±15kV air, ±8kV contact discharge Radiated RF IEC/EN 61000-4-3 3V/m immunity Radiated immunity...
  • Page 30 EMS Physio Ltd. Grove Technology Park Downsview Road Wantage Oxfordshire OX12 9FE T: 0 1 2 3 5 7 7 2 2 7 2 F : 0 1 2 3 5 7 6 3 5 1 8 E : s a l e s @ e m s p h y s i o . c o . u k W e b s i t e : h t t p : / / w w w.

This manual is also suitable for:

Ems460Primo therasonic 121Primo therasonic 120

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