Enraf Nonius Sonopuls 190 Instructions For Use Manual
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Enraf Nonius Sonopuls 190 Instructions For Use Manual

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Sonopuls 190
EN109-1631750-48 IFU
July 9, 2020
Instructions for use
Page 1 of 34
EN109-1631750-48 IFU

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  • Page 1 Sonopuls 190 EN109-1631750-48 IFU July 9, 2020 Instructions for use Page 1 of 34 EN109-1631750-48 IFU...

  • Page 2: Table Of Contents

    Table of contents Introduction ..............................3 Symbols ................................4 Device components ............................6 Package contents ............................7 Installation ................................. 8 Intended use and intended user ....................... 9 Indications ..............................10 Contraindications ............................11 Precautionary instructions ........................12 10 Operation ................................ 14 11 Application information..........................

  • Page 3: Introduction

    1 Introduction Foreword This manual has been written for the owners and operators of the Sonopuls 190. It contains general instructions on operation, precautionary practices, maintenance and parts information. In order to maximize the use, efficiency and lifespan of your unit, please read this manual thoroughly and become familiar with the controls as well as the accessories before operating the unit.

  • Page 4: Symbols

    2 Symbols Symbol used Description Follow the instructions in the Instructions for Use. It is important that you read, understand and observe the precautionary and operating instructions General Prohibition Sign. Prohibition is used to mean “You MUST NOT” Warning or Caution: Indicates a hazardous situation which, if not avoided, could result in: Death or serious injury to the patient (or) b.
  • Page 5 Pulse frequency Continuous Duty cycle Pulse duration Ultrasound frequency Alternating current “ON” (power) “OFF” (power) Page 5 of 34 EN109-1631750-48 IFU...

  • Page 6: Device Components

    3 Device components Numbered Description Purpose Part LCD display Colour TFT display 4.3” with touch screen Applicator Ultrasound applicator Multi-frequency 1 and 3 MHz Applicator holder Applicator holder. Can be mounted on the right or left side of the unit. Mains Switch To switch the unit on and off When turning the unit off the display remains visible for a...

  • Page 7: Package Contents

    Dispenser-set for 5 l canister 3442.941 Gelpad StatUS™ (240x) 3442.942 Fixation ring gelpad StatUS™ (3x) Ordering information For the ordering data of the Sonopuls 190, standard accessories and additional accessories we refer to the website www.enraf-nonius.com. Page 7 of 34 EN109-1631750-48 IFU...

  • Page 8: Installation

    Mounting the ultrasound head holder Ultrasound head/applicator holder can be mounted on the right or left of the unit. Follow the instructions given in the 0167.278 Information sheet - Mounting US Head Holder Sonopuls 190. Connection to mains supply Use of any other cable other than the supplied cable is strictly PROHIBITED as it affects patient safety and the proper function of the device.

  • Page 9: Intended Use And Intended User

    The Sonopuls 190 is intended to be used, and shall only be used, by or under the supervision of professional users in the field of physical therapy and rehabilitation, who understand the benefits and limitations of ultrasound therapy.

  • Page 10: Indications

    7 Indications Ultrasound is indicated for conditions that benefit from the application of deep heat: relief of pain, muscle spasms and joint contractures. The objective of therapeutic ultrasound in the treatment of selected medical conditions associated with the chronic and sub chronic conditions of bursitis/capsulitis, epicondylitis, ligament sprains, tendinitis, scar tissue healing and muscle strain, is to reduce pain.

  • Page 11: Contraindications

    8 Contraindications The Sonopuls 190 MUST NOT be used for the below mentioned symptoms or medical conditions. Contraindications The established contraindications to heat therapy itself. • In an area of the body where a malignancy is known to be present.

  • Page 12: Precautionary Instructions

    Inspect ultrasound applicator cables and associated connectors before each use. Do not operate the Sonopuls 190 when connected to any unit other than Enraf-Nonius BV devices. This unit should be operated in temperatures between 10 °C and 40 °C (50 °F and 104 °F), with a Relative Humidity ranging from 10%-90 % (non-condensing).
  • Page 13 Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm to any part of the Sonopuls 190, including cables specified by the manufacturer. Otherwise degradation of the performance of this equipment could result.

  • Page 14: Operation

    At the end of the self test the unit enters the Home menu and is ready for use. • Note: StatUS Therapy is enabled automatically only for Sonopuls 190 (Part number 1631.904) that comes with StatUS pack (Part number 1629.901).
  • Page 15 System Settings Set Language Push the icon “System Select from the list Language: Select your language via • • Settings”. Push icon “Language” the  icon • Push OK to confirm and to • return to the previous menu Set Brightness Select from the list Brightness: Adjust the brightness via the •...
  • Page 16 Select Ultrasound Norm Here you can select the ultrasound standard. The Sonopuls 190 offers 2 standards, the USA (FDA) and the EU standard. Default setting is the USA standard. To select a different standard, push the Ultrasound Standard icon and select another standard via the ...
  • Page 17 The parameter screen shows all Adjust the intensity level Place the applicator on the • • parameters at a glance via the  icon. treatment area (with gel). Push the intensity read-out Push OK icon to return in Contact control indicator •...
  • Page 18 Manual Operation Ultrasound Frequency Push the action icon Select a parameter in the Select the frequency by • “Manual Operation” to screen by pushing the icon. pushing the icon. activate this function Push icon [1] to change the 1 MHz is deep •...
  • Page 19 Pulse Frequency Push the icon [3] to select Select the pulse frequency via • pulse frequency the  icon. There are 3 frequencies • available 100, 48 and 16Hz Push OK to confirm and to • return to the previous menu Duty Cycle Push the icon [4] to select Select the duty cycle via the...
  • Page 20 Applicator selection Push the icon [5] to select Select the applicator A or B by Note: When no applicator is • the applicator pushing the icon. connected on the selected Push OK to confirm and to output a beeb will occur. return to the previous menu A is the left connection •...
  • Page 21 Treatment Time Push the icon [7] to select Select the treatment time via the • the treatment time  icon. Push OK to confirm and to return to the previous menu Intensity Setting Push the icon [8] to select Select the intensity level via the •...
  • Page 22 Storing a Protocol Prior to the execution of a modified protocol or manual setting, it can be saved for later use under Favorites. Push the icon [9] to store Select a program number via Notes: • the settings the  icon. Program number 0 is the •...

  • Page 23: Application Information

    11 Application information Before starting the treatment please make sure: You have read and understood the content of this manual You strictly follow the WARNINGS and CAUTIONS mentioned under precautionary instructions Check the patient for any possible contra-indications. Contact Control The ultrasound applicator has a contact control function that suspends treatment when the acoustical contact with the body drops below a certain level.
  • Page 24 After Treatment Clean the skin of the patient and the ultrasound applicator with a towel or tissue. To disinfect the treatment applicator we advise to use Dismozon® (art. no. 3442.438) in a solution between 0.25 and 1.5%. Check for the effects that can be expected (for example pain, circulation and mobility). Ask the patient to comment subsequently on any reactions that may occur.

  • Page 25: Maintenance And Troubleshooting

    12 Maintenance and troubleshooting Cleaning and Disinfection Before performing any user maintenance, switch off the device and disconnect the plug from the mains supply. Do not spray the cleaning agent directly on the glass panel. Do not use cleaning agents that contain strong alkalis, lye, acid, detergents with fluoride or detergents with ammonia.
  • Page 26 This unit operates with mains voltages. No attempt should be made to disassemble the unit. Maintenance and repair should be carried out by authorized personnel only. The manufacturer will not be held responsible for the results of maintenance or repairs by unauthorized persons.

  • Page 27: Specifications

    13 Specifications Continuous ultrasound Ultrasound parameters: Ultrasound frequency 1MHz or 3MHz Pulsed ultrasound Ultrasound parameters: Pulse frequency, 16, 48 and 100 Hz Pulse duration, set by duty cycle 5 – 80 % 0.5 – 8 ms RTPA 20 – 1.25 Description of Ultrasound Parameters Ultrasound Frequency, expressed in MHz, is the frequency of the ultrasound waves.
  • Page 28 Ultrasound Parameters Generator Duty cycle Duty cycle Duty cycle 5 – 50 % 80 % 100 % Peak output Amplitude: 0 – 3 W/cm² 0 – 2.5 W/cm² 0 – 2 W/cm² (continuous wave) Peak output power for 0 – 15 W 0 –...
  • Page 29 Description of Ultrasound Field The spatial distribution of the radiated field is a collimated beam (diverging for the 0.8 cm² applicator at 3 MHz) of ultrasound energy, with a decreasing amplitude at increasing distance from the applicator surface. This field distribution applies to the radiation emitted into the equivalent of an infinite medium of distilled, degassed water at 30 ºC and with line voltage variations in the range of ±...
  • Page 30 Technical Data Electrical info Mains voltage: 100 - 240 Volt ± 10% Frequency: 50/60 Hz Max. power consumption: 50 VA Patient leakage current: typically, 1 μA (requirements IEC < 10 μA) Idem single fault condition: typically, 2 μA (requirements IEC < 50 μA) Main Unit Dimensions Weight...
  • Page 31 Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm to any part of the Sonopuls 190, including cables specified by the manufacturer. Otherwise degradation of the performance of this equipment could result.

  • Page 32: Contact

    14 Contact For assistance, please visit our website http://www.enraf-nonius.com The latest version (in electronic or printed format) of this Instructions for Use can be obtained free of charge from our website www.enraf-nonius.com or by contacting distributor or by calling the telephone number: +31-(0)10-2030600.

  • Page 33: Product Liability

    15 Product liability A law on Product Liability has become effective in many countries. This Product Liability law implies, amongst other things, that once a period of 10 years has elapsed after a product has been brought into circulation, the manufacturer can no longer be held responsible for possible shortcomings of the product.
  • Page 34 Copyright: Enraf-Nonius B.V. Vareseweg 127 | 3047 AT | Rotterdam | The Netherlands Tel: +31 (0)10-20 30 600 | info@enraf-nonius.nl EN109-1631750-48...

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