Sonopuls 190 инструкция по применению

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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Summary of Contents for Enraf Nonius Sonopuls 190

  • 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…

Аппарат ультразвуковой терапии

Код МИ
182600
– система ультразвуковая для физиотерапии


Код КТРУ 2
6.60.13.150-00000044
– cистема ультразвуковая для физиотерапии


Аппарат Sonopuls 190 входит в оснащение по приказам №
788н
,
878н
, 1705н

Sonopuls 190 – портативный УЗ аппарат с цветным сенсорным ЖК дисплеем и без единого механического органа управления. Настройка параметров процедуры происходит быстро и наглядно.

УЗ излучатели для новой модели получили еще более удобную форму и улучшенную защиту рук терапевта от УЗ излучения. Излучатели не совместимы с предыдущими моделями аппаратов. Конструкция излучателей обеспечивает бесперебойную работу под водой, излучатели также не боятся находиться во включенном состоянии без нагрузки.

Для начинающих терапевтов меню аппарата содержит подробные рекомендации по лечению большого количества заболеваний, включающие дозировки и периодичность воздействия, а также фотографии рекомендуемого положения излучателя.

При заказе желательно сразу указать тип излучателя, с которым необходима поставка аппарата. Возможные комплектации: с излучателем 5 см2, 0,8 см2 или с обоими ультразвуковыми излучателями одновременно. Для каждого УЗ излучателя в комплекте поставляется специальный магнитный держатель, обеспечивающий безопасное хранение УЗ излучателя в периоды между процедурами.

Краткий видеообзор аппарата. Рассматривается аппарат Sonopuls 190 StatUS с модулем статического ультразвука. Управление данной моделью аналогично управлению аппарата Sonopuls 190 с классической ультразвуковой головкой.

Особенности Sonopuls 190

  • Терапия с аппаратом Sonopuls 190 (Enraf Nonius)

    Код МИ
    182600
    – система ультразвуковая для физиотерапии


    Код КТРУ 2
    6.60.13.150-00000044
    – cистема ультразвуковая для физиотерапии


    Аппарат Sonopuls 190 входит в оснащение по приказам №
    788н
    ,
    878н
    , 1705н

    Sonopuls 190 – портативный УЗ аппарат с цветным сенсорным ЖК дисплеем и без единого механического органа управления. Настройка параметров процедуры происходит быстро и наглядно.

    УЗ излучатели для новой модели получили еще более удобную форму и улучшенную защиту рук терапевта от УЗ излучения. Излучатели не совместимы с предыдущими моделями аппаратов. Конструкция излучателей обеспечивает бесперебойную работу под водой, излучатели также не боятся находиться во включенном состоянии без нагрузки.

    Для начинающих терапевтов меню аппарата содержит подробные рекомендации по лечению большого количества заболеваний, включающие дозировки и периодичность воздействия, а также фотографии рекомендуемого положения излучателя.

    При заказе желательно сразу указать тип излучателя, с которым необходима поставка аппарата. Возможные комплектации: с излучателем 5 см2, 0,8 см2 или с обоими ультразвуковыми излучателями одновременно. Для каждого УЗ излучателя в комплекте поставляется специальный магнитный держатель, обеспечивающий безопасное хранение УЗ излучателя в периоды между процедурами.

    Краткий видеообзор аппарата. Рассматривается аппарат Sonopuls 190 StatUS с модулем статического ультразвука. Управление данной моделью аналогично управлению аппарата Sonopuls 190 с классической ультразвуковой головкой.

    Особенности Sonopuls 190

    • Терапия с аппаратом Sonopuls 190 (Enraf Nonius)русифицированный графический интерфейс
    • сменные многочастотные излучатели 5 см2и 0,8 см2
    • малый вес и габариты аппарата
    • цветной сенсорный ЖК дисплей 55×95 мм
    • предустановленные программы терапии

    Технические характеристики

    Рабочая частота УЗ излучателей 1 и 3 МГц
    Эффективная площадь излучения 5 см2и 0,8 см2
    Режим работы импульсный (несколько градаций скважности) и непрерывный
    Частоты импульсного режима 16, 48, 100 (длительность импульса 12, 8, 4 мс)
    Вес 0,8 кг
    Габаритные размеры 17 х 14 х 7 см
    Электропитание 220В 50 Гц 45 Вт

    Стандартная комплектация

    Фото Наименование Каталожный номер Количество
    Контактный гель для УЗ излучаталей Стартовый комплект УЗ контактного геля 250 мл для аппаратов ультразвуковой терапии Sonopuls 9999.408 1
    Многочастотный ультразвуковой излучатель к аппаратам Sonopuls 190, 490, 492 Стартовый комплект УЗ контактного геля 250 мл для аппаратов ультразвуковой терапии Sonopuls 9999.408 1
    Многочастотный ультразвуковой излучатель к аппаратам Sonopuls 190, 490, 492 УЗ многочастотный излучатель большой 5 см2, 1/3 МГц 1630.905 1
    Сетевой кабель   1
    Инструкция по эксплуатации на оборудование Enraf-Nonius, поставщик OCTOMED Сетевой кабель   1
    Инструкция по эксплуатации на оборудование Enraf-Nonius, поставщик OCTOMED Инструкция пользователя аппарата для ультразвуковой терапии Sonopuls 190 на русском языке   1

    Дополнительная комплектация

    Фото Наименование Каталожный номер
    Роликовая подставка Encar для аппаратов Sonopuls, Endomed, Endolaser (Enraf Nonius) Роликовая подставка EN-Car 1468.950
    Многочастотный ультразвуковой  излучатель малый,  для Sonopuls 190 Роликовая подставка EN-Car 1468.950
    Многочастотный ультразвуковой  излучатель малый,  для Sonopuls 190 Многочастотный УЗ излучатель, малый 0,8 см2 1630.915
    Методическое пособие на оборудование для физиотерапии и реабилитации_OCTOMED Методические пособия для аппаратов ультразвуковой терапии Sonopuls  
    Контактный гель для УЗ излучаталей к аппаратам Sonopuls (Enraf Nonius) Методические пособия для аппаратов ультразвуковой терапии Sonopuls  
    Контактный гель для УЗ излучаталей к аппаратам Sonopuls (Enraf Nonius) Контактный гель для ультразвуковой терапии, 12 бутылок по 250 мл 3442.929
  • Page 1
    Sonopuls 190 Bedieningshandleiding Operating Instructions Gebrauchsanweisung Mode d´emploi Instrucciones de manejo Guía de usuario…
  • Page 2
    Copyright: Enraf-Nonius B.V. P.O. Box 12080 Vareseweg 127 3004 GB Rotterdam The Netherlands Tel: +31 (0)10 – 20 30 600 Fax: +31 (0)10 – 20 30 699 info@enraf-nonius.nl www.enraf-nonius.com Part number: 1631750 — 42 January 13, 2014…
  • Page 4
    Sonopuls 190 Bedieningshandleiding Operating Instructions Gebrauchsanweisung Mode d´emploi Instrucciones de manejo Guía de usuario…
  • Page 6: Table Of Contents

    INHOUDSOPGAVE PRODUCTBESCHRIJVING …………………… 12 VOORWOORD ………………………. 12 Deze handleiding ……………………..12 Productaansprakelijkheid ………………….12 VOORZORGSVOORSCHRIFTEN …………………. 13 Waarschuwing: ……………………..13 Let op: ………………………… 13 BEDOELD GEBRUIK VAN ULTRAGELUIDTHERAPIE …………..14 Indicaties/contra-indicaties en negatieve effecten bij ultrageluidtherapie ……14 Parameters ……………………….15 INHOUD VAN DE VERPAKKING …………………..

  • Page 7
    9.1.3 Ultrageluidapplicator ……………………. 26 Verhelpen van storingen ………………….. 27 9.2.1 Foutcode ……………………… 27 Technisch onderhoud ……………………27 9.3.1 Contact controle herstellen en fabriekswaarden terugzetten……….. 27 Einde levensduur ……………………… 28 SPECIFICATIES ……………………..28 10.1.1 Continuu ultrageluid ……………………28 10.1.2 Pulsed ultrasound ……………………28 10.2 Ultrageluid-parameters ……………………
  • Page 8
    Guidance and manufacturer’s declaration – electromagnetic immunity ……..54 10.4.2 Guidance and manufacturer’s declaration – electromagnetic immunity ……..54 10.4.3 Recommended separation distances between portable and mobile RF communications equipment and the Sonopuls 190 ………………….55 10.5 Technical Data ……………………..56 PRODUKTBESCHREIBUNG ………………….57 VORWORT……………………….57 Dieses Handbuch ………………………
  • Page 9
    Anschluß an die Hauptversorgung ………………..61 HINWEISE FÜR DIE ANBRINGUNG ………………..61 7.1.1 Kontaktkontrolle ……………………61 7.1.2 Das Kontaktmedium ……………………. 61 7.1.3 Vor der Behandlung ……………………61 7.1.4 Während der Behandlung ………………….62 7.1.5 Nach der Behandlung ………………….. 62 Betriebsanleitung ……………………… 62 NORMALBETRIEB ……………………..
  • Page 10
    PRÉCAUTIONS D’EMPLOI ……………………. 81 Avertissements: ……………………..81 Precautions: ………………………. 81 INDICATION DU TRAITEMENT PAR ULTRASONS …………….. 82 Indications/Contre-indications et effets défavorables des Ultrasons ……..82 Paramètres ……………………….83 CONTENU DES EMBALLAGES ………………….83 Standard Accessories ultrasound ………………..83 Accessoires optionnels ……………………. 83 INSTALLATION ………………………
  • Page 11
    SPECIFICATIONS ……………………… 96 10.1.1 Ultrason continue ……………………96 10.1.2 Ultrason pulsé ……………………… 96 10.2 Paramètres ultrason ……………………96 10.3 Normes de sécurité et de fonctionnement ……………… 98 10.4 Electromagnétisme ……………………98 10.5 Données techniques ……………………101 DESCRIPCIÓN DEL PRODUCTO ………………..102 PRÓLOGO ……………………….
  • Page 12
    8.5.7 Tiempo de Tratamiento ………………….114 8.5.8 Ajuste de Intensidad …………………… 114 Almacenaje de un Protocolo ………………….. 114 8.6.1 Cargar en menú Favoritos …………………. 115 MANTENIMIENTO Y SOLUCIÓN DE PROBLEMAS …………… 116 Mantenimiento del Usuario………………….116 9.1.1 Limpieza del aparato ………………….. 116 9.1.2 Limpieza del Panel display ………………….
  • Page 13
    FUNZIONAMENTO DI BASE ………………….132 Accensione dell’apparecchio ………………… 132 Home menu ……………………..132 Impostazioni di sistema ………………….132 8.3.1 Impostazione della lingua ………………….. 132 8.3.2 Impostazione del Luminosità LCD ………………133 8.3.3 Selezione della norma ultrasuoni ………………. 133 8.3.4 Info sistema ……………………..133 Caricamento dei protocolli clinici ………………..
  • Page 14: Productbeschrijving

    De gebruiker kan twee ultrageluidbehandelkoppen aansluiten. Deze kunnen vanuit het ultrageluidmenu worden geactiveerd. WAARSCHUWING (geldt alleen voor de VS): De Sonopuls 190 is een apparaat op voorschrift dat alleen dient te worden gebruikt onder supervisie of op voorschrift van een arts of andere bevoegde zorgverlener. 2 Voorwoord 2.1 Deze handleiding…

  • Page 15: Voorzorgsvoorschriften

    • Inspecteer vóór elk gebruik de kabels van de ultrageluidapplicator en bijbehorende connectoren. • Gebruik de Sonopuls 190 niet wanneer deze is aangesloten op een andere unit dan een apparaat van Enraf-Nonius BV. • Deze unit dient te worden bediend, getransporteerd en opgeslagen bij temperaturen tussen 10 en 40 °C (50 en 104 °F) met een relatieve luchtvochtigheid variërend van 10-100%.

  • Page 16: Bedoeld Gebruik Van Ultrageluidtherapie

    4 Bedoeld gebruik van ultrageluidtherapie Ultrageluid is mechanische energie die bestaat uit hoogfrequente trillingen die door middel van een ultrageluidapplicator worden toegediend. Deze trillingen gaan door het weefsel van het lichaam en worden geleidelijk geabsorbeerd en omgezet in warmte. De resulterende temperatuurstijging veroorzaakt biologische veranderingen in het weefsel die leiden tot verlichting van pijn, relaxatie van spierspasmen en vermindering van gewrichtscontracturen.

  • Page 17: Parameters

    5 Inhoud van de verpakking 1631901 Sonopuls 190, inclusief grote behandelkop 1631902 Sonopuls 190, inclusief kleine behandelkop 1631903 Sonopuls 190, inclusief grote en kleine behandelkop 5.1 Standard Accessores ultrasound 3444929 Flesje UG gel van 250 ml, 1/12 3444357 Stroomkabel 5.2 Optional Accessories…

  • Page 18: Installatie

    6 Installatie 6.1 Aansluiting op het lichtnet • Steek het netsnoer in aansluiting [4] en sluit het aan op een wandcontactdoos. Steek de kabel van de ultrageluidkop in aansluiting [7] of [8]. • ! ! ! ! LET OP: • Plaats de unit niet op een plaats waar de stroomkabel er tijdens een behandeling uit kan worden getrokken of waar men erover kan struikelen.

  • Page 19: Na De Behandeling

    • Vraag de patiënt regelmatig naar zijn/haar bevindingen. Zo nodig zal de behandeling moeten worden aangepast. De amplitude kan worden verlaagd of de continue modus kan worden veranderd in pulserende modus of vice versa. • Als er aanwijzingen zijn dat de ultrageluidsoverdracht slecht is, moet meer contactgel worden aangebracht of de aanwezige gel worden uitgestreken met de applicator.

  • Page 20
    Voor gecombineerde toepassingen mag alleen Enraf-Nonius apparatuur type BF worden gebruikt. De zeer lage lekstroom van dit type apparatuur staat garant voor een absoluut veilige behandeling.
  • Page 21: Bediening

    • Aan het einde van de zelftest verschijnt het hoofdmenu en is de unit klaar voor gebruik. 8.2 Hoofdmenu The Sonopuls 190 is uitgevoerd met een touch-screen bediening. Door op een icoon te drukken springt u naar het betreffeden menuonderdeel.

  • Page 22: Instellen Van De Helderheid

    8.3.3 Selecteer de ultrageluidnorm U kunt een ultrageluidnomr selecteren. De Sonopuls 190 kent 2 standaarde, de USA (FDA) norm en de standaard EU normen. De voorkeursinstelling is USA. Een andere norm kan men instellen door deze te selecteren met behulp van de toetsen.

  • Page 23: Handbediening

    • • Het parameters scherm toont alle Pas de intensiteit aan met Plaats de behandelkop op parameters in een overzicht. behulp van de toetsen. het te behandelen gebied • • Druk op de (voorzien van UG-gel) Bevestig de selectie met de •…

  • Page 24: Puls Modus Continu Of Intermitterend

    8.5.2 Puls modus continu of intermitterend • Druk op A of B Indien de continue modus is Druk op toets [3] om de puls • geselecteerd dan zijn geen modus te veranderen. A is gepulseerde modus • andere instellingen mogelijk B is continue modus (geen Frequentie of Duty Cycle).

  • Page 25: Duty Cycle

    8.5.4 Duty Cycle • Selecteer de duty cycle met Druk op toets [6] om de duty behulp van de toetsen. cycle te veranderen. • Er zij 6 instellingen mogelijk, 80, 50, 33, 20, 10 en 5% • Bevestig de selectie met de “OK”…

  • Page 26: Eenheden

    8.5.6 Eenheden • Selecteer de gewenste eenheid Druk op toets [8] om de van de ultrageluidsintensiteit eenheden te veranderen. door op de betreffende toets te drukken. • Er zij 2 mogelijkheden, Watt/cm² en Watt. • Bevestig de selectie met de “OK”…

  • Page 27: Intensiteit

    8.5.8 Intensiteit • Verander de intensiteit met Druk op toets [10] om de behulp van de toetsen. bintensiteit te veranderen. • Bevestig de selectie met de “OK” toets. U gaat dan automatisch terug naar het vorige scherm. 8.6 Protocol opslaan Voorafgaand aan de uitvoering van een aangepast protocol of van een handmatig ingestelde behandeling kunnen de instellingen opgeslagen worden onder de favorieten.

  • Page 28: Favorieten Laden

    Zorg ervoor dat er geen ultrageluid-gel op de applicator achterblijft. Aanbevolen wordt de applicator en kabel dagelijks met lauw water te reinigen. De applicator kan worden gedesinfecteerd met het schoonmaakmiddel Dismozon® (verkrijgbaar bij Enraf-Nonius onder art. nr. 3442438). Controleer de applicator en de kabel regelmatig op beschadiging.

  • Page 29: Verhelpen Van Storingen

    U kunt dit laten doen door uw leverancier of door een andere, door Enraf-Nonius geautoriseerde, instantie. Het is tevens raadzaam een dossier bij te houden van alle uitgevoerde servicewerkzaamheden. In sommige landen is dit zelfs verplicht.

  • Page 30: Einde Levensduur

    9.4 Einde levensduur De Sonopuls 190 bevat materialen die kunnen worden hergebruikt en/of schadelijk zijn voor het milieu. Gespecialiseerde bedrijven kunnen de unit demonteren en deze materialen eruit halen. Wanneer u de unit afvoert, dient u zich te informeren over de plaatselijke regels m.b.t. afvalbeheer.

  • Page 31
    Ultrageluid behandelkop 5 cm² Ultrageluid-frequentie: 1 MHz : 0.98 MHz ± 2% 3 MHz : 3.1 MHz ± 2% ERA (effectief stralingsoppervlak): IEC 60601-2-5: 2000 : 4 cm 21 CFR 1050.10 : 5 cm Bundeltype: 1 MHz : Collimerend 3 MHz : Collimerend BNR (Beam Non-uniformity Ratio) : 6:1 max.
  • Page 32: Normen Met Betrekking Tot Veiligheid En Prestaties

    Richtlijn en verklaring van de fabrikant – elektromagnetische immuniteit De Sonopuls 190 is bedoeld voor gebruik in de hieronder beschreven elektromagnetische omgeving. De klant of de gebruiker van de Sonopuls 190 dient te verzekeren dat deze wordt gebruikt in een dergelijke omgeving.

  • Page 33
    Richtlijn en verklaring van de fabrikant – elektromagnetische immuniteit De Sonopuls 190 is bedoeld voor gebruik in de hieronder beschreven elektromagnetische omgeving. De klant of de gebruiker van de Sonopuls 190 dient te verzekeren dat deze wordt gebruikt in een dergelijke omgeving.
  • Page 34: Technische Gegevens

    Sonopuls 190 normaal werkt. Als een abnormale werking wordt waargenomen, kunnen aanvullende maatregelen nodig zijn, zoals het in een andere richting zetten of verplaatsen van de Sonopuls 190. In het frequentiebereik 15 kHz tot 8 MHz dienen de veldsterktes minder dan 3 V / m te zijn.

  • Page 35
    Netfrequentie : 50 / 60 Hz Hoofd-unit: Afmetingen : 21 x 19 x 9 cm (b x d x h) Gewicht : 760 gr. Omgevingscondities voor transport en opslag: Temperatuur : -20 tot +70 °C Relatieve vochtigheid : 10 tot 50 % (23°C in originele verpakking) : 10 tot 90 % (40°C in originele verpakking) Atmosferische druk : 500 tot 1060 hPa…
  • Page 37: Product Description

    The user can connect two ultrasound applicators. These can be activated from the ultrasound menu. WARNING (USA only): The Sonopuls 190 is a prescription device that should only be used under the supervision or by the order of a physician or other licensed healthcare provider.

  • Page 38: 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, transported and stored in temperatures between 10 °C and 40 °C (50 °F and 104 °F), with a Relative Humidity ranging from 10%-100%.

  • Page 39: Intended Use Ultrasound Therapy

    4 Intended Use Ultrasound therapy Ultrasound is a mechanical energy consisting of high-frequency vibrations applied by means of an ultrasound applicator. These vibrations pass through the tissue of the body and are gradually absorbed and transformed into heat. The resulting temperature increase triggers biological changes to occur in the tissue for the relief of pain, relaxation of muscle spasms and reduction of joint contractures.

  • Page 40: Package Contents

    1631.901 Sonopuls 190, including a large ultrasound applicator 1631.902 Sonopuls 190, including a small ultrasound applicator 1631.903 Sonopuls 190, including a small and large ultrasound applicator 5.1 Standard Accessories ultrasound 3444.929 Contact-gel, bottle of 250 ml, 1/12 3444.357 Mains connecting cable 5.2 Optional Accessories…

  • Page 41: Installation

    6 Installation 6.1 Connection to mains supply • Insert the mains cable into socket [4] and connect it to a wall socket. Connect the applicator on socket [7] or [8].         CAUTION: • Do not place the unit in a location where the power cord could be tripped over or pulled out during treatment.

  • Page 42: After Treatment

    The ultrasound applicator has to be moved constantly, also with the semi-static method. During treatment the displayed ultrasound Amplitude can vary around the set value, caused by fluctuations in acoustical coupling. Ask the patient regularly for his/her findings. If necessary the treatment will have to be adapted. The Amplitude can be reduced or the continuous mode can be changed to pulsed mode or vice versa.

  • Page 43
    For combined applications only use Enraf-Nonius type BF equipment. The very low leakage current of this type of equipment ensures absolutely safe therapy.
  • Page 44: Basic Operation

    At the end of the self test the unit enters the Home menu and is ready for use. 8.2 Home menu The Sonopuls 190 is equipped with touch screen technology. Via the menu you can access to all functions. Select the desired function by pushing an icon.

  • Page 45: Set Contrast

    8.3.2 Set Contrast • Select from the Brightness: Adjust the brightness via • Push icon “Brightness” icon Push OK to confirm and to return to the previous menu 8.3.3 Select Ultrasound Norm Here you can select the ultrasound standard. The Sonopuls offers 2 standards, the USA (FDA) and the EU standard.

  • Page 46: Manual Operation

    • • The parameter screen shows all Adjust the intensity level via Place the applicator on the parameters at a glance icon. treatment area (with gel). • • • Push the intensity read-out to Push OK icon to return in the Contact control indicator change the intensity level.

  • Page 47: Continuous / Pulsed Mode

    8.5.2 Continuous / pulsed mode • Push A or B If continuous pulse mode is Push the icon [3] to select • selected no other parameters continuous or pulsed mode A is pulsed mode • (Frequency or Duty Cycle) are B is continuous mode available.

  • Page 48: Duty Cycle

    8.5.4 Duty Cycle • Select the duty cycle via the Push the icon [6] to select icon. Duty Cycle • There are 6 settings available 80, 50, 33, 20, 10 and 5% • Push OK to confirm and to return to the previous menu 8.5.5 Applicator selection •…

  • Page 49: Units

    8.5.6 Units • Select the desired read-out of the Push the icon [8] to select ultrasound intensity. “units” There are 2 read-outs, Watt/cm² and Watt. Push OK to confirm and to return to the previous menu 8.5.7 Treatment time • Select the treatment time via the Push the icon [9] to select icon.

  • Page 50: Intensity Setting

    8.5.8 Intensity setting • Select the intensity level via the Push the icon [8] to select icon. intensity setting Push OK to confirm and to return to the previous menu 8.6 Storing a protocol Prior to the execution of a modified protocol or manual setting, it can be saved for later use under Favorites.

  • Page 51: Maintenance And Troubleshooting

    To prevent corrosion, clean and dry the contact surface immediately after use. Make sure that no ultrasound gel remains on the applicator. To disinfect the treatment applicator we advice to use Dismozon® pur. in a solution between 0,25 and 1,5%. This product can be ordered at Enraf-Nonius under the number 3442438.

  • Page 52: Troubleshooting

    We further recommend cleaning the applicator and cable daily, using lukewarm water. Check the applicator and cable regularly for damage. 9.2 Troubleshooting 9.2.1 Error code When the apparatus is turned on, it will first execute a self test. When an error is detected, both during the self test and during normal operation, a pop-up screen will appear on the display.

  • Page 53: Specifications

    9.4 End of life The Sonopuls 190 contains materials that can be recycled and/or are noxious to the environment. Specialized companies can dismount the unit and sort out these materials. When you dispose of the unit, find out about local regulations concerning waste management.

  • Page 54
    5 cm² Applicator Ultrasound frequency: 1 MHz : 0.98 MHz ± 2 % 3 MHz : 3.1 MHz ± 2 % ERA (Effective Radiation Area): IEC 60601-2-5: 2000 : 4 cm² 21 CFR 1050.10 : 5 cm² Beam type: 1 MHz : Collimating 3 MHz : Collimating…
  • Page 55: Safety And Performance Standards

    Guidelines and manufacturer’s declaration – electromagnetic interference The Sonopuls 190 intended for operation in an electromagnetic environment as indicated below. The customer or user of the Sonopuls 190 should ensure that it is operated in such an environment. Interference tests…

  • Page 56: Guidance And Manufacturer’s Declaration – Electromagnetic Immunity

    10.4.1 Guidance and manufacturer’s declaration – electromagnetic immunity The Sonopuls 190 is intended for use in the electromagnetic environment specified below. The customer or the user of the Sonopuls 190 should assure that it is used in such an environment. Immunity test…

  • Page 57: Recommended Separation Distances Between Portable And Mobile Rf Communications Equipment And The Sonopuls 190

    If the measured field strength in the location in which the Sonopuls 190 is used exceeds the applicable RF compliance level above, the Sonopuls 190 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the Sonopuls 190.

  • Page 58: Technical Data

    10.5 Technical Data Mains voltage : 100 – 240 V ± 10% Mains frequency : 50 / 60 Hz Main unit: Dimensions : 21 x 19 x 9 cm (w x d x h) Weight : 760 gr. Environmental conditions for transport and storage: Temperature : -20°…

  • Page 59: Produktbeschreibung

    1 Produktbeschreibung Das Sonopuls 190 is ein Multi-Frequenz-Ultraschallgerät. Die Multi-Frequenz-Ultraschall- Applikatoren für den Sonopuls 190 ermöglichen den Betrieb mit 1 und 3 MHz. Die Applikatoren können sowohl bei großen als auch bei kleinen Behandlungsflächen verwendet werden und sind auch für Unterwasserbehandlungen geeignet.

  • Page 60: Vorsichtsmaßnahmen

    3 Vorsichtsmaßnahmen In diesem Abschnitt sind allgemeine Warn- und Vorsichtshinweise aufgeführt, die Sie kennen sollten, wenn Sie den Sonopuls 190 benutzen. Siehe auch Kapitel 4 für applikationsspezifische Warn- und Vorsichtshinweise. 3.1 WARNUNG: • Nach den Bundesgesetzen (nur für die USA) darf dieses Gerät nur von einem Arzt oder zugelassenen Heilpraktiker oder auf dessen Anordnung hin verkauft werden.

  • Page 61: Verwendungszweck Der Ultraschalltherapie

    4 Verwendungszweck der Ultraschalltherapie Ultraschall ist eine mechanische Energie, bestehend aus Vibrationen hoher Frequenz, die mit einem Ultraschallapplikator verabreicht werden. Diese Vibrationen dringen durch das Gewebe des Körpers und werden allmählich absorbiert und in Hitze umgewandelt. Der resultierende Temperaturanstieg verursacht im Gewebe biologische Änderungen zur Schmerzlinderung, Lösung von Muskelkrämpfen und Linderung von Gelenkkontrakturen.

  • Page 62: Parameter

    Sonopuls 190, inklusiv Applikator, 1-3 MHz, ERA 5 cm² 1631902 Sonopuls 190, inklusiv Applikator, 1-3 MHz, ERA 0,8 cm² 1631903 Sonopuls 190, inklusiv Applikator, 1-3 MHz, ERA 5 cm² und ERA 0,8 cm² 5.1 Standardzubehör 3444929 Kontaktgel Ultraschall 250 ml, 1/12…

  • Page 63: Installation

    6 Installation 6.1 Anschluß an die Hauptversorgung • Stecken Sie das Hauptversorgungskabel in die Steckdose [4] und schließen sie es an eine Wand-Steckdose an. Stecken Sie die Applikatoren in die Steckdose [7] und [8]. ! ! ! !     VORSICHT: •…

  • Page 64: Während Der Behandlung

    7.1.4 Während der Behandlung • Der Ultraschall — Applikator muß permanent bewegt werden, auch bei der semi-statischen Methode. Während der Behandlung kann die angezeigte Ultraschall — Amplitude aufgrund von Fluktuationen der akustischen Kopplung um den eingestellten Wert herum variieren. • Fragen Sie den Patienten regelmäßig nach seinen/ihren Erfahrungen.

  • Page 65
    Der Anschluß von Zubehör, welches nicht vom Hersteller vorgesehen ist, kann die Sicherheit des Patienten und das korrekte Funktionieren der Geräte beeinträchtigen und ist daher nicht zulässig. Verwenden Sie bei kombinierten Anwendungen nur Geräte von Enraf-Nonius Typ BF. Der sehr geringe Leckstrom dieser Art von Ausrüstung gewährleistet eine absolut sichere Therapie.
  • Page 66: Normalbetrieb

    Nach der Selbstprüfung, wird das Menü „Home“ geöffnet und kann verwendet werden. 8.2 Startbildschirm Der Sonopuls 190 nutzt die Touchscreen-Technologie. Über das Menü können Sie auf alle Funktionen zugreifen. Wählen Sie die gewünschte Funktion durch Drücken auf ein Symbol aus.

  • Page 67: Den Lcd Helligkeit Einstellen

    8.3.2 Den LCD Helligkeit einstellen • Wählen Sie den Kontrast aus der Drücken Sie auf OK, um Ihre Stellen Sie den LCD Liste „ LCD Helligkeit “ aus. Auswahl zu bestätigen und Helligkeit mit den • zum vorherigen Menü Symbolen ein.

  • Page 68: Manuelle Bedienung

    • • Der Parameterbildschirm zeigt Stellen Sie den Platzieren Sie den Applikator eine Übersicht aller Parameter Intensitätsgrad mithilfe der (mit Gel) im Bereich, der Symbole ein. behandelt werden soll. • • • Drücken Sie auf den Drücken Sie auf OK, um zum Die Kontaktkontrollanzeige Intensitätswert, um den vorherigen Menü…

  • Page 69: Kontinuierlicher Modus/Impulsmodus

    zurückzukehren. 8.5.2 Kontinuierlicher Modus/Impulsmodus • Drücken Sie auf A oder B. Falls der kontinuierliche Drücken Sie auf das Symbol • Impulsmodus ausgewählt ist, [3], um den kontinuierlichen A ist der Impulsmodus • sind keine weiteren Parameter Modus oder den B ist der kontinuierliche (Frequenz oder Duty Cycle) Impulsmodus auszuwählen.

  • Page 70: Auslastung

    8.5.4 Auslastung • Wählen Sie die Auslastung Drücken Sie auf das Symbol mithilfe der Symbole aus. [6], um die Auslastung • auszuwählen. Es stehen 6 Einstellungen zur Verfügung: 80, 50, 33, 20, 10 und 5 % • Drücken Sie auf OK, um Ihre Auswahl zu bestätigen und zum vorherigen Menü…

  • Page 71: Einheiten

    8.5.6 Einheiten • Wählen Sie die gewünschte Drücken Sie auf das Symbol Anzeige für die Ultraschall- [4], um die Einheiten intensität. Es stehen 2 Anzeigen auszuwählen. zur Verfügung: Watt/cm² und Watt. Drücken Sie auf OK, um Ihre Auswahl zu bestätigen und zum vorherigen Menü…

  • Page 72: Intensitätseinstellung

    8.5.8 Intensitätseinstellung • Wählen Sie den Intensitätsgrad Drücken Sie auf das Symbol mithilfe der Symbole aus. [10], um die Drücken Sie auf OK, um Ihre Intensitätseinstellung Auswahl zu bestätigen und zum auszuwählen. vorherigen Menü zurückzukehren 8.6 Ein Protokoll speichern Vor der Ausführung eines geänderten Protokolls oder einer manuellen Einstellung kann es bzw. sie zur späteren Verwendung unter “Favoriten”…

  • Page 73: Die Favoriten Laden

    8.6.1 Die Favoriten laden • • Wählen Sie eine Programm Drücken Sie auf das Symbol Platzieren Sie den Applikator mithilfe der Symbole aus. Favoriten. (mit Gel) im Bereich, der behandelt werden soll. • Die Kontaktkontrollanzeige schaltet sich aus und die die Behandlungszeit beginnt (der Countdown startet).

  • Page 74: Fehlersuche

    empfehlen Dismozon® für diesen Reinigungsjob (Art. Nr. 3442438). Untersuchen Sie den Applikator und das Kabel regelmäßig auf Schäden. 9.2 Fehlersuche 9.2.1 Fehlercode Wenn der Apparat eingeschaltet ist, wird er zunächst einen Selbsttest durchführen. Wenn ein Fehler entdeckt wird, sei es beim Selbsttest oder während des normalen Betriebs, wird eine Pop-up-Seite auf dem Display erscheinen.

  • Page 75: Ende Der Lebensdauer

    Symbolen 9.4 Ende der Lebensdauer Die Sonopuls 190 enthält Materialien, die recycelt werden können und/oder für die Umwelt schädlich sind. Spezialisierte Unternehmen können das Gerät auseinanderbauen und diese Materialien aussortieren. Wenn Sie das Gerät entsorgen, informieren Sie sich über lokale Vorschriften bzgl. der Abfallbeseitigung.

  • Page 76: Ultraschall — Parameter

    10.2 Ultraschall — Parameter Generator Spitzenausstoß Amplitude: Impulszyklus 5 – 50 % : 0 – 3 W/cm² Impulszyklus 80 % : 0 – 2,5 W/cm² Impulszyklus 100 % : 0 – 2 W/cm² (durchgängige Welle) Spitzenausstoßleistung für 5 cm² — Applikator: Impulszyklus 5 –…

  • Page 77: Sicherheits- Und Leistungsstandards

    • International: IEC 60601-2-5: 2000 • USA: 21 CFR 1050.10 Der Strahl-Nicht-Uniformitäts-Quotient ist der Quotient aus der maximalen Ultraschallamplitude und der durchschnittlichen Ultraschallamplitude, gemessen an der Effektiven Strahlungsfläche. Ein niedriger BNR- Wert ist ein Zeichen für die Abwesenheit hoher und potentiell gefährlicher Energie- Konzentrationen.

  • Page 78: Anleitung Und Erklärung Des Herstellers– Elektromagnetische Immunität

    Flicker gemäß IEC 61000-3-3 10.4.1 Anleitung und Erklärung des Herstellers– elektromagnetische Immunität Das Sonopuls 190 dient zur Verwendung in dem u.a. elektromagnetischen Umfeld. Der Kunde oder Benutzer des Sonopuls 190 sollte sicherstellen, dass es in einem solchen Umfeld verwendet wird.

  • Page 79
    Anleitung und Erklärung des Herstellers– elektromagnetische Immunität Das Sonopuls 190 ist für die Verwendung in dem u.a. elektromagnetische Umfeld vorgesehen. Der Kunde oder Benutzer des Sonopuls 190 sollte sicherstellen, dass es in einem solchen Umfeld verwendet wird Immunitätstest IEC 60601 Testniveau Erfüllungs-…
  • Page 80
    Leistung des 150 kHz bis 80 MHz 80 MHz bis 800 800 MHz bis 2,5 GHz Transmitters d = [3,5/V ]√P d = [7/E ]√P d = [3,5/E ]√P [ W ] 0,01 0,12 0,12 0,23 0,37 0,37 0,74 1,17 1,17 2,33 3,69…
  • Page 81: Technische Daten

    10.5 Technische Daten Hauptversorgungsspannung : 100 – 240 V ± 10% Hauptversorgungsfrequenz : 50 / 60 Hz Hauptgerät: Dimensionen : 21 x 19 x 9 cm (w x d x h) Gewicht : 4,75 Kg Dimensionen : 39 x 37 x 6 cm (w x d x h) Gewicht : 760 gr.

  • Page 82: Description Du Produit

    1 Description du produit Le Sonopuls 190 présente un canal multi — fréquences. Les têtes de traitement de la Sonopuls 190 sont multi — fréquences, deux surfaces différentes sont disponibles et chacune est compatible pour l’application de 1 ou 3 MHz. Elles conviennent aux traitements effectués dans l’eau.

  • Page 83: Précautions D’emploi

    3 Précautions d’emploi Dans ce paragraphe sont exposés les avertissements et précautions générales à connaître avant d’utiliser les appareils de la Sonopuls 190. Voir aussi le chapitre 4 sur les avertissements et précautions lors des applications plus spécifiques. 3.1 Avertissements: •…

  • Page 84: Indication Du Traitement Par Ultrasons

    4 Indication du traitement par ultrasons Les ultrasons ou énergie mécanique à base de vibrations à haute fréquence appliquées à l’aide d’un applicateur d’ultrasons (tête de traitement). Ces vibrations traversent les tissus corporels et sont graduellement absorbées et transformées en chaleur. L’augmentation de la température, en déclenchant des changements biologiques dans les tissus, soulage la douleur et favorise le relâchement musculaire.

  • Page 85: Paramètres

    Sonopuls 190, avec une grande tête de traitement 1631902 Sonopuls 190, avec une petite tête de traitement 1631903 Sonopuls 190, avec une grande ét une petite tête de traitement 5.1 Standard Accessories ultrasound 3444929 Gel pour ultrasons, flacon de 250 ml, 1/12 3444357 Câble secteur…

  • Page 86: Installation

    6 Installation 6.1 Connection au secteur • Insérez le câble secteur dans la prise de l’appareil [4] puis dans la prise murale. Insérez le câble de la tête de traitement dans la prise de l’appareil [7] ou [8]. ! ! ! ! …

  • Page 87: Après Le Traitement

    • Interrogez régulièrement le patient sur ses sensations. Au besoin le traitement devra être adapté. La puissance peut être réduite ou le mode continu peut être changé en mode pulsé ou vice versa. • Lorsque des signes montrent que la transmission est mauvaise, ajoutez du gel de contact ou étalez le avec la tête de traitement.

  • Page 88
        PRECAUTIONS: • Le raccordement d’accessoires autres que ceux indiqués par Enraf-Nonius peut compromettre la santé du patient et influer négativement sur le fonctionnement des appareils, il n’est pas donc pas autorisé. Pour des applications combinées utiliser uniquement un équipement BF Enraf-Nonius.
  • Page 89: Utilisation De Base

    À la fin du test, l’appareil affiche le menu initial : il peut à présent être utilisé. 8.2 Menu initial Le Sonopuls 190 est équipé d’un écran tactile. Il est possible d’accéder à l’ensemble des fonctions via le menu. Sélectionnez la fonction de votre choix en effleurant une icône.

  • Page 90: Modifier Le Luminosit’s Écran

    8.3.2 Modifier le luminosit’s écran • Sélectionnez le contraste désiré. Réglez le contraste au • Touchez « Luminosité moyen de l’icône « ». écran ». Touchez « OK » pour confirmer votre choix et revenir au menu précédent. 8.3.3 Sélectionner une norme d’ultrasons Cette fonction permet de sélectionner une norme d’ultrasons.

  • Page 91: Manipulation Manuelle

    • • L’écran des paramètres affiche Réglez le niveau d’intensité Placez la tête de traitement l’ensemble des paramètres. au moyen de l’icône sur la surface à traiter (avec • Touchez l’indicateur « ». du gel). • • d’intensité pour en modifier le Touchez «…

  • Page 92: Mode Continu/Pulsé

    8.5.2 Mode continu/pulsé • Touchez A ou B : Si vous sélectionnez le mode Touchez [3] pour • pulsé/continu, aucun autre sélectionner le mode continu « A » correspond au mode paramètre (« Fréquence » ou ou pulsé. pulsé. • «…

  • Page 93: Rapport Cyclique (« Duty Cycle «)

    8.5.4 Rapport cyclique (« Duty Cycle ») • Sélectionnez le rapport cyclique Touchez [6] pour au moyen de l’icône « ». sélectionner le type de • rapport cyclique. 6 types de rapports sont disponibles : 80, 50, 33, 20, 10 et 5%. •…

  • Page 94: Unités

    8.5.6 Unités • Sélectionnez l’indicateur Touchez [4] pour d’intensité ultrasonique de votre sélectionner l’appareil. choix. Deux possibilités : Watt/cm² et Watt. Touchez « OK » pour confirmer votre choix et revenir au menu précédent. 8.5.7 Temps de traitement • Sélectionnez le temps de Touchez [9] pour traitement au moyen de l’icône sélectionner le temps de…

  • Page 95: Réglage De L’intensité

    8.5.8 Réglage de l’intensité • Réglez le niveau d’intensité au Touchez [8] pour paramétrer moyen de l’icône « ». l’intensité. Touchez « OK » pour confirmer votre choix et revenir au menu précédent. 8.6 Sauvegarder un protocole Avant d’exécuter un protocole modifié ou de procéder à un réglage manuel, il est possible de sauvegarder les changements dans les «…

  • Page 96: Charger Les Favoris

    8.6.1 Charger les favoris • • Sélectionnez un programme au Touchez « Favorites » Placez la tête de traitement moyen de l’icône « ». (« Favoris »). sur la surface à traiter (avec du gel). • L’indicateur de contact s’éteint et la minuterie du traitement s’enclenche (compte à…

  • Page 97: Résolution De Problèmes

    nettoyage (numéro 3442438 d’art.) dans une solution de 0.25 à 1.5%. Examinez régulièrement tête et câble pour déceler des dommages. 9.2 Résolution de problèmes 9.2.1 Code erreur Quand l’appareil démarre, il doit d’abord exécuter un auto-test. Quand une erreur est détectée, soit pendant l’auto-test soit pendant l’utilisation un écran instantané…

  • Page 98: Ultrason Continue

    ». 9.4 Fin de vie La Sonopuls 190 contiennent des matériaux qui peuvent être recyclés et/ou peuvent être nocifs pour l’environnement. Des sociétés spécialisées peuvent récupérer l’appareil et trier ces matériaux. En cas de mise au rebut de l’appareil se renseigner sur les lois au sujet de la gestion des déchets.

  • Page 99
    Puissance pour tête de 5 cm² : Cycle actif 5 – 50 % : 0 – 15 W Cycle actif 80 % : 0 – 12 W Cycle actif 100 % : 0 – 10 W (mode continu) Puissance pour tête de 0.8 cm² : Cycle actif 5 –…
  • Page 100: Normes De Sécurité Et De Fonctionnement

    10.4 Electromagnétisme Directives et déclaration du fabricant – interférence électromagnétique La Sonopuls 190 a été conçu pour fonctionner dans un environnement électromagnétique comme indiqué ci-après. Le client ou utilisateur de la Sonopuls 190 doit s’assurer qu’il est utilisé dans un tel…

  • Page 101
    IEC 61000-3-3 Conseils et déclaration du fabricant – immunité électromagnétique Les appareils de la Sonopuls 190 sont prévus pour l’utilisation dans l’espace électromagnétique indiqué ci-dessous. Le client ou l’utilisateur doit s’assurer d’un tel environnement. Essai d’immunité…
  • Page 102
    émetteurs fixes de RF, une enquête sur leurs emplacements devrait être envisagée. Si les effets de ces champs, dans la zone d’utilisation des appareils de la Sonopuls 190, excèdent le niveau applicable de conformité de RF ci-dessus, il faudrait vérifier que le fonctionnement des appareils de la Sonopuls 190 est normal.
  • Page 103: Données Techniques

    RF et les appareils de la Sonopuls 190 Les appareils de la Sonopuls 190 peuvent fonctionner dans un espace où les perturbations de RF sont contrôlées. Le client ou l’utilisateur des appareils de la Sonopuls 190 peut aider à empêcher l’interférence électromagnétique en gardant une distance minimale, comme conseillée ci-dessous, entre le matériel RF…

  • Page 104: Descripción Del Producto

    El usuario puede conectar dos cabezales de contacto en el tratamiento de ultrasonido. Estas pueden activarse desde el menú principal. AVISO (solo USA): La Sonopuls 190 es un equipo de prescripción que solo debería ser usado bajo supervisión o por cualquier otra persona con la titulación y los conocimientos oportunos.

  • Page 105: Instrucciones De Precaución

    En esta sección se informa de una lista de avisos y precauciones que se deben tomar, que debe usted tener en cuenta una vez que comience a usar la Sonopuls 190. Véase también el capítulo 4 también dedicado a avisos y precauciones de aplicación específica.

  • Page 106: Uso De La Terapia De Ultrasonidos

    4 Uso de la Terapia de Ultrasonidos El ultrasonido es una energía mecánica que consiste en aplicar vibraciones de alta fecuencia mediante un aplicador. Estas vibraciones pasan a través del tejido del cuerpo y son gradualmente absorbidas y transformadas en calor. La temperatura resultante se incrementa para combatir el dolor produciendo cambios biológicos en el tejido, se produce una relajación del músculo, espasmos y reduce contracturas.

  • Page 107: Parámetros

    1631901 Sonopuls 190, con aplicador de ultrasonido grande 1631902 Sonopuls 190, con aplicador de ultrasonido pequeño 1631903 Sonopuls 190, con aplicador de ultrasonido grande y pequeño 5.1 Standard Accessories ultrasound 3444929 Gel de contacto, botella de 250 ml, 1/12 3444357 Cable de Red 5.2 Optional Accessories…

  • Page 108: Notas De Aplicación

    7 Notas de Aplicación 7.1 Ultrasonido 7.1.1 Control de contacto El aplicador de ultrasonido tiene una función de control de contacto que suspende el tratamiento cuando el contacto acústico con el cuerpo baja de un cierto nivel. La luz indicadora en el aplicador cambia de señal en esta situación.

  • Page 109: Después Del Tratamiento

    7.1.5 Después del tratamiento • Limpie la piel del paciente y el aplicador de ultrasonido con una toalla. Limpie el aplicador con una solución de 70% de alcohol. Recomendamos Dismozon® para este trabajo de la limpieza (arte. No. 3442438) en una solución de 0.25 a 1.5%. •…

  • Page 110: Manejo Básico

    Para la combinación de aplicaciones, use solo el equipo del tipo BF Enraf-Nonius. La baja pérdida de corriente de este tipo de equipo asegura la absoluta seguridad de la terapia.

  • Page 111: Ajustes Del Sistema

    Ajustes del Sistema 8.3.1 Ajuste de Idioma • • Seleccione de la lista de Idioma: Pulse el icono de “Ajustes Seleccione su idioma • de sistema”. Pulse el icono de “Idioma” mediante el icono pq . • Pulse OK para confirmar y volver al menú…

  • Page 112: Carga De Protocolos Clínicos

    8.4 Carga de Protocolos Clínicos El Sonopuls tiene 25 Seleccionar en la lista el sugerencias de tratamientos para tratamiento que requiera o: • las terapias mas comunes de Pulse el icono i para más ultrasonido. información sobre • Pulse el icono “Protocolos protocolos.

  • Page 113: Modo Continuo // Modo Pulsado

    • Seleccione un parámetro en la Seleccione la frecuencia Pulse el icono “Manual de pantalla pulsando el icono que pulsando en el icono. Función” para activar esta • corresponda.. función. 1 MHz – es profunda • • Pulse el icono [1] para 3 MHz –…

  • Page 114
    • Seleccione la frecuencia de Pulse el icono [5] para Pulso mediante el icono : seleccionar la frecuencia de • pulso. Hay 3 frecuencias disponibles: 100, 48 y 16Hz • Pulse OK para confirmar la acción y volver al menú anterior 8.5.4 Duty Cycle…
  • Page 115: Selección Del Aplicador

    8.5.5 Selección del Aplicador • Seleccione el aplicador A o B Cuando no hay ningún aplicador Pulse el icono [2] para pulsando el icono conectado en la salida seleccionar el aplicador que correspondiente.Pulse OK para seleccionada, una señal sonora requiera. confirmar y volver al menú…

  • Page 116: Tiempo De Tratamiento

    8.5.7 Tiempo de Tratamiento • Seleccione el tiempo de Pulse el icono [9] para tratamiento vía el icono: seleccionar el tiempo de Pulse OK para confirmar y tratamiento. volver al menú anterior. 8.5.8 Ajuste de Intensidad • Seleccione el nivel de intensidad Pulse el icono [8] para mediante el icono: seleccionar la intensidad.

  • Page 117: Cargar En Menú Favoritos

    • Seleccione un número de Notas: Pulse el icono [7] para • programa via el icono almacenar los ajustes. Programa no. 0 es el modo Pulse OK para confirma esta de inicio establecido por accion y volver al menú anterior. defecto.

  • Page 118: Mantenimiento Y Solución De Problemas

    9 Mantenimiento y solución de problemas 9.1 Mantenimiento del Usuario 9.1.1 Limpieza del aparato Para limpiar la unidad, apáguela y desenchúfela de la toma de corriente. Límpiela con un trapo húmedo. No use productos abrasivos. Puede usarse una pequeña cantidad de detergente si se precisa. Recomendamos Dismozon®…

  • Page 119: Vida Útil Del Aparato

    9.4 Vida útil del aparato El Equipo Sonopuls 190 contiene material reciclable y algunos otros materiales nocivos para el medio ambiente. Compañías especializadas pueden encargarse de desmontar la unidad y ocuparse de estos materiales. Cuando tenga el equipo en su poder, debe informarse y conocer las regulaciones locales en…

  • Page 120: Especificaciones

    10 Especificaciones         Parámetros de ultrasonido: 10.1.1 Ultrasonido continuo     Frequencia ultrasonido 1MHz o 3MHz         Parámetros de ultrasonido: 10.1.2 Ultrasonido intermitente Frecuencia de pulso, 100 Hz fija Duración de pulso, fijar para duty cycle 5 –…

  • Page 121
    Tipo de rayo: 1 MHz : Colimación 3 MHz : Colimación BNR (Rango del Rayo de No-uniformidad: 6:1 máximo Radiación lateral : 10 mW/cm² máximo Aplicador de 0.8 cm² Frecuencia de ultrasonido: 1 MHz : 0.98 MHz ± 2 % 3 MHz : 3.1 MHz ±…
  • Page 122: Estándares De Seguridad Y Funcionamiento

    10.3 Estándares de Seguridad y Funcionamiento IEC 60601-1 : Requerimientos generales de seguridad eléctrica y sistemas eléctricos médicos, incluyendo anexo 1, diferencias en Australia, Canadá y USA. Clase de seguridad acorde con IEC 60601-1 : clase I tipo BF IEC 60601-2-5 : Requerimientos particulares para seguridad en equipos de terapia de ultrasonido.

  • Page 123: Datos – Emc

    Dirección y Declaración del Fabricante – Inmunidad Electromagnética La Sonopuls 190 está diseñada para su uso en los ambientes electromagnéticos aquí especificados. El cliente o el usuario de una Sonopuls 190 debe asegurarse de que es usado en el ambiente adecuado. Test de inmunidad…

  • Page 124
    NOTA U T es el voltaje de red a.c. anterior a la aplicación del nivel de test. El funcionamiento esencial de la Sonopuls 190 es el siguiente: la entrega libre de interferencias de los ultrasonidos, control sin interferencias de todas las funciones. Funcionamiento ininterrumpido no es necesario con el uso previsto.
  • Page 125
    El cliente o usuario de la Sonopuls 190 puede ayudar a prevenir las interferencias electromagnéticas manteniendo una mínima distancia entre el equipo de comunicaciones RF portátiles y móviles (transmisores) y la Sonopuls 190 como se recomienda abajo, de acuerdo a la salida máxima de potencia del equipo de comunicaciones.
  • Page 126: Datos Técnicos

    10.5 Datos técnicos Voltaje de red : 100 – 240 V ± 10% Frecuencia de red : 50 / 60 Hz Unidad de red: Dimensiones : 21 x 19 x 9 cm (w x d x h) Peso : 760 gr. Condiciones ambientales para transporte y almacenaje: Temperatura : -20°…

  • Page 127: Descrizione Del Prodotto

    Il Sonopuls 190 ad ultrasuoni presenta un unico canale ad ultrasuoni a multi-frequenza. Gli applicatori ad ultrasuoni a multi-frequenza per la Sonopuls 190 consentono operazioni a 1 e a 3 Mhz. Gli applicatori possono essere utilizzati nel caso di superfici grandi o ridotte, e sono adatti per trattamenti subacquali.

  • Page 128: Istruzioni Preventive

    Prima di ogni impiego, ispezionare i cavi e le corrispondenti connessioni dell’applicatore ultrasonico. • Non far funzionare la Sonopuls 190 in connessione ad un qualsiasi altro dispositivo diverso dalle apparecchiature Enraf-Nonius. • Questo dispositivo dev’essere fatto funzionare, trasportato e immagazzinato a temperature comprese tra 10 e 40 °C (50 e 104 °F), con un tasso di umidità…

  • Page 129: Uso Previsto Della Terapia A Ultrasuoni

    4 Uso previsto della terapia a ultrasuoni Quella ultrasonica è un’energia meccanica che consiste in vibrazioni ad alta frequenza, applicate mediante un applicatore di ultrasuoni. Queste vibrazioni passano lungo il tessuto corporeo e vengono gradatamente assorbite e trasformate in calore. Il risultante aumento di temperatura determina l’insorgere di cambiamenti biologici nel tessuto, risultanti in sollievo dal dolore, rilassamento di spasmi muscolari e riduzione di contratture alle giunture.

  • Page 130: Parametri

    1631901 Sonopuls 190, con applicatore per ultrasuoni grande 1631902 Sonopuls 190, con applicatore per ultrasuoni piccolo 1631903 Sonopuls 190, con applicatore per ultrasuoni grande y piccolo 5.1 Accessori standard 3444929 Flacone gel, US, 250 ml, 1 pz 3444357 Cordone d’alimentazione 5.2 Accessori opzionali…

  • Page 131: Installazione

    6 Installazione 6.1 Connessione all’alimentazione di rete • Inserire il cordone di rete nella presa [4] e connetterlo ad una presa di rete a muro. Inserire il cordone di applicatore nella presa [7] o [8]. CAUTELA: • Non sistemare l’apparecchio in una posizione in cui ci si possa incespicare sul cordone d’alimentazione, o estrarlo durante il trattamento.

  • Page 132: Durante Il Trattamento

    7.1.4 Durante il trattamento • L’applicatore ultrasonico dev’essere mosso costantemente, anche nel caso del metodo semi-statico. Durante il trattamento, l’ampiezza ultrasonica visualizzata può variare attorno al valore impostato, a causa di fluttuazioni nell’accoppiamento acustico. • Chiedere con frequenza al paziente le sue sensazioni. Se necessario, il trattamento dev’essere adattato.

  • Page 133
    La connessione di accessori diversi da quelli preconizzati dal costruttore può influire negativamente sulla sicurezza del paziente e sul corretto funzionamento dell’attrezzatura, e non è quindi permessa. Per applicazioni combinate, utilizzare soltanto attrezzature Enraf-Nonius di tipo BF. La perdita di corrente di questo tipo di dispositivo, molto ridotta, assicura una terapia assolutamente sicura.
  • Page 134: Funzionamento Di Base

    Al termine dell’autoverifica, l’unità accede al menu Home ed è pronta per l’uso. 8.2 Home menu Il dispositivo Sonopuls 190 è dotato di tecnologia touchscreen. Attraverso il menu si può accedere a tutte le funzioni. Selezionare la funzione desiderata premendo un’icona.

  • Page 135: Impostazione Del Luminosità Lcd

    8.3.2 Impostazione del Luminosità LCD • Selezionare un fattore di Regolare il contrasto contrasto dal menu luminosità: utilizzando l’icona • • Premere l’icona «Luminosità Premere OK per confermare LCD». e tornare al menu precedente. 8.3.3 Selezione della norma ultrasuoni In questa sezione è possibile selezionare la norma relativa agli ultrasuoni. Sonopuls offre 2 norme: quella statunitense (FDA) e quella dell’Unione Europea.

  • Page 136: Funzionamento Manuale

    • • Sulla schermata dei parametri Regolare il livello di intensità Sistemare l’applicatore sono visualizzati tutti i parametri. utilizzando l’icona sull’area da trattare • • Premere la lettura (utilizzando il gel). Premere l’icona OK per • dell’intensità per cambiare il ritornare al menu L’indicatore di controllo livello di intensità.

  • Page 137: Modalità Di Funzionamento Continuo/Pulsato

    8.5.2 Modalità di funzionamento continuo/pulsato • Premere A o B. Se viene selezionata la modalità Premere l’icona [3] per • di funzionamento continuo, non selezionare la modalità di A per la modalità di sarà disponibile nessun altro funzionamento continuo o funzionamento pulsato.

  • Page 138: Ciclo Di Lavoro (Duty Cycle)

    8.5.4 Ciclo di lavoro (Duty Cycle) • Selezionare il ciclo di lavoro Premere l’icona [6] per utilizzando l’icona selezionare il ciclo di lavoro. • Sono disponibili 6 impostazioni: 80, 50, 33, 20, 10 e 5%. • Premere OK per confermare e tornare al menu precedente.

  • Page 139: Units

    8.5.6 Units • Selezionare l’unità desiderata per Premere l’icona [4] per l’intensità ultrasuoni. selezionare le «unità». Sono disponibili 2 unità: Watt/cm² e Watt. Premere OK per confermare e tornare al menu precedente. 8.5.7 Tempo di trattamento • Selezionare il tempo di Premere l’icona [9] per trattamento utilizzando l’icona selezionare il tempo di…

  • Page 140: Impostazione Dell’intensità

    8.5.8 Impostazione dell’intensità • Selezionare il livello di intensità Premere l’icona [8] per utilizzando l’icona selezionare l’impostazione Premere OK per confermare e dell’intensità. tornare al menu precedente. 8.6 Salvataggio di un protocollo Prima di eseguire un protocollo modificato o un’impostazione manuale, è possibile salvarli nella cartella Preferiti per riutilizzarli in futuro.

  • Page 141: Caricamento Dei Preferiti

    8.6.1 Caricamento dei Preferiti • • Selezionare un programma Premere l’icona Preferiti. Sistemare l’applicatore utilizzando l’icona sull’area da trattare (utilizzando il gel). • L’indicatore di controllo contatto si spegne e inizia il conto alla rovescia del tempo di trattamento. Se il contatto non è sufficiente, l’indicatore si illumina e il conto del tempo di trattamento viene interrotto.

  • Page 142: Risoluzione Dei Problemi

    l’applicatore e il suo cavo quotidianamente, utilizzando acqua tiepida. L’applicatore può essere disinfettato. Suggeriamo Dismozon® per questo lavoro di pulizia (art. no. 3442438) in una soluzione di 0.25 — 1.5%. Verificare l’applicatore ed il cavo regolarmente, per rilevare eventuali danneggiamenti. 9.2 Risoluzione dei problemi 9.2.1 Codice d’errore…

  • Page 143: Termine Della Durata Di Vita

    «Impostazioni di sistema». 9.4 Termine della durata di vita I modelli Sonopuls 190 contengono materiali che possono essere riciclati e/o dannosi per l’ambiente. Aziende specializzate possono disassemblare questo apparecchio e recuperare questi materiali. Quando si elimina questo apparecchio, consultare le regolamentazioni locali a proposito della gestione dei materiali di scarto.

  • Page 144: Parametri Degli Ultrasuoni

    10.2 Parametri degli ultrasuoni Generatore Ampiezza d’uscita di picco: Ciclo di funzionamento 5 – 50% : 0 – 3 W/cm² Ciclo di funzionamento 80% : 0 – 2,5 W/cm² Ciclo di funzionamento 100 % : 0 – 2 W/cm² (onda continua) Potenza d’uscita di picco per un applicatore da 5 cm²: Ciclo di funzionamento 5 –…

  • Page 145: Norme Di Sicurezza E Prestazioni

    emessa, nell’equivalente di un mezzo infinito di acqua distillata e degassata a 30 °C, e con le variazioni della tensione della linea nella forbice di ±10% del valore nominale. Il fascio ultrasonico è caratterizzato dall’area di radiazione efficace (ERA), e dal rapporto di non uniformità del fascio (BNR). L’area di radiazione efficace rappresenta l’area trasversale del fascio ultrasonico.

  • Page 146: Dettagli Emc

    Linee guida e dichiarazione del produttore — interferenze elettromagnetiche La Sonopuls 190 è progettato per funzionare in un ambiente elettromagnetico come descritto di seguito. Il cliente o l’utente di la Sonopuls 190 devono garantire che sia utilizzato in tale ambiente.

  • Page 147
    Consigli e dichiarazione del costruttore – Immunità elettromagnetica La Sonopuls 190 è prevista per un impiego nell’ambiente elettromagnetico specificato qui sotto. Il ciente o l’utente della Sonopuls 190 deve assicurare che tale dispositivo viene utilizzato in un tale ambiente. Test d’immunità…
  • Page 148
    La Sonopuls 190 è prevista per un impiego in un ambiente elettromagnetico in cui i disturbi irradiati RF possono essere controllati. Il cliente o l’utente della Sonopuls 190 può prevenire interferenze elettromagnetiche mantenendo una distanza minima tra le attrezzature di comunicazione RF portatili e mobili (trasmettitori) e la Serie come da consigli più…
  • Page 149: Dati Tecnici

    10.5 Dati tecnici Tensione di alimentazione di rete : 100 – 240 V ± 10% Frequenza dell’alimentazione di rete : 50 / 60 Hz Apparecchio principale: Dimensioni : 21 x 19 x 9 cm (a x p x h) Peso : 760 gr.

Enra Nonius Sonopuls 190 User manual

Sonopuls 190

SERVICE MANUAL

Part number: 1416770

Enraf-Nonius B.V.

Sonopuls 190 Service Manual

1416770

Sonopuls 190

SERVICE MANUAL

Copyright:

Enraf-Nonius B.V.

P.O.Box 810

2600 AV Delft

The Netherlands

part number: 1416.770-41

PDF master 23022001

Enraf-Nonius B.V.

Sonopuls 190 Service Manual

1416770

CONTENTS

Date of issue

page

1

INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

July 1999 1-1

1.1

INTRODUCTORY REMARKS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

July 1999 1-1

1.2

GENERAL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

July 1999 1-3

1.3

TECHNICAL DATA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

July 1999 1-4

2

DESCRIPTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

July 1999 2-1

3

TEST EQUIPMENT AND TOOLS . . . . . . . . . . . . . . . . . . . . . . . . . . . .

July 1999 3-1

3.1

TEST EQUIPMENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

July 1999 3-1

3.2

TOOLS AND MATERIALS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

July 1999 3-1

4

MAINTENANCE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

July 1999 4-1

4.1

GENERAL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

July 1999 4-1

4.2

CHECKLIST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

July 1999 4-1

4.3

FUNCTIONAL TEST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

July 1999 4-1

4.4

TROUBLE SHOOTING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

July 1999 4-3

4.5

REPLACEMENT PROCEDURES . . . . . . . . . . . . . . . . . . . . . . . . . . . .

July 1999 4-4

4.6

ADJUSTMENT PROCEDURES . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

July 1999 4-5

5

STORAGE AND TRANSPORT . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

July 1999 5-1

5.1

STORAGE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

July 1999 5-1

5.2

TRANSPORT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

July 1999 5-1

6

SPARE PARTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

July 1999 6-1

6.1

ORDERING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

July 1999 6-1

6.2

WARRANTEE CLAIMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

July 1999 6-1

6.3

REPAIR SERVICE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

July 1999 6-2

6.4

RETURN SHIPMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

July 1999

6-2

Enraf-Nonius B.V.

Sonopuls 190 Service Manual

1416770

CONTENTS (contd.)

APPENDIX A SPARE PARTS LIST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

July 1999 A-1

APPENDIX B DRAWINGS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

July 1999 B-1

Fig. 1

Block diagram . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

July 1999 B-1

Fig. 2 Sonopuls 190 front view . . . . . . . . . . . . . . . . . . . . . . . . . . . .

July 1999 B-2

Fig. 3 Sonopuls 190 side view . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

July 1999 B-3

Fig. 4

Sonopuls 190 front inside incl. PC Board . . . . . . . . . . . . . . .

July 1999 B-4

Fig. 5

Sonopuls 190 Main PC Board . . . . . . . . . . . . . . . . . . . . . . . .

July 1999 B-5

Fig. 6

Ultrasound Treatment Head wiring details. . . . . . . . . . . . . . .

July 1999

B-7

APPENDIX C SERVICE INFO’S(Product Change Notes) . . . . . . . . . . . . . . . . .

July 1999

C-1

C.1

GENERAL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

July 1999

C-1

C.2

REVISION HISTORY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

July 1999

C-2

Enraf-Nonius B.V.

Sonopuls 190 Service Manual

1416770

Enraf-Nonius B.V.

Sonopuls 190 Service Manual

1416770

1 INTRODUCTION

1.1INTRODUCTORY REMARKS

This manual has been written for the technicians involved in the service of the Sonopuls 190. Service can be carried out by the service organization of the supplier or by any other technician authorized by Enraf-Nonius B.V.

The manufacturer will not be held responsible for the results of maintenance or repairs by unauthorized persons.

Enraf-Nonius B.V. is further referred to as Enraf-Nonius

1.1.1Safety Aspects

Safe execution of the procedures in this manual requires technical experience and general knowledge of safety precautions.

Warnings, Cautions and Notes have been used throughout the manual to bring special matters to the immediate attention of the reader.

The Warning concerns danger to the safety of the technician or user;

The Caution draws attention to an action which may damage the equipment;

The Note points out a statement deserving more emphasis than the general text, but which does not deserve a Warning or Caution.

The sequence of steps in a procedure may also be important from the point of view of personal safety and prevention of damage, therefore never change the sequence of procedural steps or alter a procedure.

1.1.2Legal Aspects

This manual and the information herein are copyright property of Enraf-Nonius B.V. (Delft, The Netherlands).

Enraf-Nonius B.V. disclaims any responsibility for personal injury and/or damage to equipment caused by:

Negligence or disregard of a Warning or Caution;

Deviation from any of the prescribed procedures;

Execution or activities which are not prescribed;

Ignorance of the general safety precautions for handling tools and the use of electricity;

Repairs and/or adjustments made to the equipment with a patient connected.

1.1.3Environmental Aspects

The following materials have been used for construction of the Sonopuls 190:

material:

Polyester

Control panel.

material:

ABS

Housing of the unit, UTH. housing and UTH. holder.

material:

MDF

Supporting plate.

Please dispose off properly in case of replacement according to the local regulations.

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1.1.4Data registration

1.1.4.1Equipment and customer registration/Service file

From the point of view of safety and product liability the following data must be registered for each unit:

Equipment data:

Type (part) and serial number

Customer data:

Date of delivery of the equipment to the customer, name and full

address of the customer

Configuration file:

The actual configuration data of the equipment.

Service file:

Data of all service activities

The distributor as well as their dealer and/or service organization if any, is responsible for these records. They must be able to provide these data when requested.

1.1.4.2Configuration file

A configuration file gives the serial numbers and/or batch numbers of main sub-assemblies and/or important parts per unit. The parts listed in a configuration file are defined as registered parts. Such are for example parts as transformers, PC Boards, key-boards and software. The registered parts of the Sonopuls 190 are marked with a «Y» for «Yes» in the spare parts list in appendix A (column C).

Enraf-Nonius has the original configuration file of each unit. Any possible changes in the original configuration of the supplied units must be filed and the distributor must be able to provide this data. These changes can simply be stored in the service file of the specific unit. Part, serial or batch number(s) of the new parts have to be mentioned.

In case of a claim we expect the distributor to report the claim and the actual configuration data of the equipment in question.

1.1.5Product documentation

The documentation set for the Sonopuls 190 also incudes an Instruction manual and a therapy book. The instruction manual is a recommended item for all service engineers.

Ordering data:

1416.750 Instruction manual

1416.770 Service manual

1482.762 Therapy book «Ultrasound Therapy»

1.1.6Installation

(For installation of the Sonopuls 190 see the Operating Instruction manual.)

It is not allowed to use this unit in so-called «wet rooms» (hydrotherapy rooms).

The mains supply connections must comply with the national requirements regarding medical used rooms.

Before connection of this apparatus to the mains supply, check that the mains voltage and frequency stated on the type plate of the power supply adapter corresponds to that of

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the mains supply. The mains supply adapter which is used for the Sonopuls 190 unit (ENB-1530) can be used for mains voltages between 100 to 240 VAC 50 — 60 Hz.

1.1.7Modifications

This publication could include technical inaccuracies or typographical errors. Changes are periodically made to the information herein; these changes will be published as Service Info’s in appendix C of this Service Manual.

1.1.8Product evaluation

In order to continuously improve the quality of our products, Enraf-Nonius requests her service organizations to report any structural problem which may be discovered. When the same problem regularly occurs or when safety problems occur, we would like you to send us a product complaint report. The report must contain the name, the type of the product, a detailed description of the problem, the number of the same problems, quantity of sold equipment and your solution to the problem (if any). The product complaint report can be found as an enclosure in the Service Reference book.

1.1.9Additional Information

Please do not hesitate to contact your National sales organisation or distributor. For additional information:

Enraf-Nonius B.V. P.O. Box 810 2600 AV Delft The Netherlands

Tel: +31 (0)15 — 2698400 Telefax: +31 (0)15 — 2624317 Telex: 38083 nl

1.2GENERAL

The Sonopuls 190 is a single channel Ultra Sound (US.) unit which operates with a frequency of 1Mhz. The compact design, the simple operation and the bright LED displays makes the Sonopuls 190 very useful as a stand-alone US. unit.

The Ultra sound Treatment Head (UTH) has a fixed connection to the unit and can not be connected to other units without unit calibration.

The Sonopuls 190 has been designed and manufactured to ensure the highest level of safety; the unit itself fully complies with the IEC 601-1 and IEC 601-1-2 standards. The power supply complies with the IEC 950 standards.

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1.3TECHNICAL DATA

1.3.1

General

Power supply unit:

Mains supply adapter

: ENB-1530

Mains supply voltage

: 100 — 240VAC.

Mains frequency

: 50-60 Hz

Supply adapter output voltage

: 15 VDC.

Supply adapter output current

: min. 2 A.

Sonopuls 190 unit:

Current consumption

: max. 1.8 A

Patient leakage current

: typical 1 A

(IEC requirement 100 A)

Ditto, single fault condition

: typical 1 A

(IEC requirement 500 A)

Safety class

: II 1) type, BF 2)

Safety approval

: CE-MDD (TÜV Rheinland) 3)

Radio interference compliance

: EN60601-1-2 : 1993

Dimensions

: 22 x 19.5 x 20 cm

Weight

: 1.7 kg

Colour specification

: EN. Custom colours

1)II: The equipment has a double insulation.

2)BF: The equipment has a floating patient circuit. The Sonopuls 190 meets the requirements of IEC 601 safety standards.

3)Copies of certificates or certificates of conformity (COC) are available on request.

1.3.2European union:

4)This equipment complies with all requirements of the EMC for the Medical Device Directive (93/42/EEG).

1.3.3Ultrasound therapy

Ultrasound frequencies

: 1 MHz ± 0,2 %

Output mode

: continuous

Pulse frequency/ duty cycle

: 100 Hz / 100%

Intensity

: 0

— 2

W/cm2 continuous

Output mode

: pulsed

Pulse frequency/ duty cycle

: 100 Hz / 5, 10, 20, 50, 100%

Intensity

: 0

— 3

W/cm2, duty cycle 5, 10, 20, 50%

: 0

— 2

W/cm2, duty cycle 80%

Contact control threshold level

: 65 % of initial value

(min. output power 0.3W/cm² = 1.5 W)

Display modes

: intensity in W/cm2 and output power in W (SATP 4))

Indication accuracy

: ± 20 % (for any level above 10 % of maximum)

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Timer

: 0 — 30 minutes, coupled to contact control, 0 — 10

minutes in 0.5 minute steps, 10 — 30 minutes in 1

minute steps

4)SATP: Spatial Average Temporal Peak (mean pulse power)

1.3.4Ultrasound Treatment Heads

Treatment head, large, 1 MHz:

Geometrical surface

: 6.2 cm²

ERA 5)

: 5.0 cm²

BNR 6)

: Max. 6.0

Type

: Collimating

Side wall radiation

: Max.10 mW/cm²

5)The Effective Radiating Area (ERA) is defined as the geometrical area of a plane (in square centimetres), parallel to, and at a distance of 5 mm from the front of the treatment head, where the ultrasound intensity is more than 5 % of the maximum intensity in that plane.

6)The Beam Non-uniformity Ratio (BNR) is defined as the ratio of the maximum peak intensity somewhere in the ultrasound beam and the effective intensity of that ultrasound beam.

ERA and BNR are measured according to the FDA definitions

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2DESCRIPTION

Because of the modular construction of the Sonopuls 190 the description is on block diagram level.

2.1BLOCK DIAGRAM (see appendix B fig. 1)

The electronic circuit of the Sonopuls 190 is located on 2 modules:

Application / display module (also referred to as main PC Board).

User interface module (also referred to as keyboard)

The Ultrasound Treatment Head (UTH) is connected to the unit without using an connector which makes it unable to disconnect the UTH by the user. The electronic circuit of the treatment head (feedback circuit) is found on the main PC Board. The treatment heads used with other series are equipped with a feedback and an head id. circuit inside the UTH which makes the heads interchangeable with other units. Other units are able to provide two output frequencies 1 and 3 Mhz, the Sonopuls 190 unit is a single frequency unit. Because the UTH which is used with the Sonopuls 190 unit does not have this circuits inside, the UTH must be calibrated to the unit in question. One advantage is that the treatment cable is available as a spare part because it is a part of the electronic circuit. The calibration routine covers the complete unit including cable and treatment head assembly.

2.1.1Application module (main PC Board)

The function of the application module is to supply the Ultra Sound (US.) drive current for the Ultrasound Treatment Head (UTH) connected to the Sonopuls 190 unit.

The Ultra Sound drive current is an alternating current at a frequency of 1MHz and can be either continuous or pulsed mode.

The application module comprises the following circuits:

US. micro controller circuit

US. measuring circuits

US. driver and output stages

Timer circuits

LED display

The ultrasound treatment head connected to the Sonopuls 190 unit is specially designed and it has a permanent connection to the unit. The UTH. does not have a connector and therefore it is not possible to disconnect it from the unit.

2.1.2User interface module (keyboard)

The keyboard is found at the front of the Sonopuls 190 unit. The switch-matrix is decoded at the main PC Board. The LED displays ( which are a part of the main PC Board) will give a clear view of the treatment parameters and treatment timer.

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Table of Contents for Enraf Nonius Sonopuls 190:

  • Page 29 of 34 EN109-1631750-48 IFU 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 ± 10% of the rated value. The ultra

  • Page 27 of 34 EN109-1631750-48 IFU 13 Specifications Continuous ultrasound Ultrasound parameters: Ultrasound frequency 1MHz or 3MHz Pulsed ultrasound Ultrasound parameters: f p Pulse frequency, 16, 48 and 100 Hz t Pulse duration, set by duty cycle 5 – 80 % t 0.5 – 8 ms RTPA 20 – 1.25 Description of Ultrasound Parameters Ultrasound Frequency, expressed in MHz, is the frequency of the ultrasound waves. The ultrasound frequency determines the penetration d

  • Page 20 of 34 EN109-1631750-48 IFU Applicator selection • Push the icon [5] to select the applicator Select the applicator A or B by pushing the icon. Push OK to confirm and to return to the previous menu • A is the left connection • B is the right connection Note: When no applicator is connected on the selected output a beeb will occur. Units • Push the icon [6] to select “units” Select the desired read-out of the ultrasound intensity. • There are 2 rea

  • Page 24 of 34 EN109-1631750-48 IFU 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 28 of 34 EN109-1631750-48 IFU Ultrasound Parameters Generator Duty cycle 5 – 50 % Duty cycle 80 % Duty cycle 100 % Peak output Amplitude: 0 – 3 W/cm² 0 – 2.5 W/cm² 0 – 2 W/cm² (continuous wave) Peak output power for 5 cm² applicator: 0 – 15 W 0 – 12 W 0 – 10 W (continuous wave) Peak output power for 0.8 cm² applicator: 0 – 2.4 W 0 – 2 W 0 – 1.6 W (continuous wave) Output meter uncertainty

  • Page 21 of 34 EN109-1631750-48 IFU Treatment Time • Push the icon [7] to select the treatment time Select the treatment time via the  icon. Push OK to confirm and to return to the previous menu Intensity Setting • Push the icon [8] to select intensity setting Select the intensity level via the  icon. Push OK to confirm and to return to the previous menu 7 8

  • Page 32 of 34 EN109-1631750-48 IFU 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. The Instructions for Use will be sent (free of charge) to you within 7 (seven) calendar days.

  • Page 8 of 34 EN109-1631750-48 IFU 5 Installation Inspection In case of damage from transport is noticed, contact your local distributor. DO NOT USE the device! Immediately upon unpacking the device, perform the following steps: • Verify the delivery documents to make sure that the delivery is complete. • Verify that the packaging contains all the items listed in the standard accessories list • Chec

  • Page 15 of 34 EN109-1631750-48 IFU System Settings Set Language • Push the icon “System Settings”. Select from the list Language: • Push icon “Language” • Select your language via the  icon • Push OK to confirm and to return to the previous menu Set Brightness Select from the list Brightness: • Push icon “Brightness” • Adjust the brightness via the  icon Push OK

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