Zimmer Soleo Sono Instructions For Use Manual
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Zimmer Soleo Sono Instructions For Use Manual

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Instructions for Use
Soleoline
Soleo Sono
EN

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Summary of Contents for Zimmer Soleo Sono

  • Page 1 Instructions for Use Soleoline Soleo Sono...
  • Page 3 Explanation of Symbols Soleo Sono Front panel Fig. 1 Device and 1 Intensity controller channel I operating 2 Controller for frequency portion elements 3 Tray mount for ultrasound head 4 Display 5 Touch pen in holder 6 Slot for SD card...
  • Page 4 Explanation of Symbols Soleo Sono Display/ Navigation bars Fig. 2 Displays 7 Status bar 8 Buttons on the screen 9 Title bar 10 Navigation bars Fig. 3 Navigation bar (A) Back Moves back one step Description of (B) Memory Switches to the memory area...
  • Page 5 11 On/off switch connector sockets 12 Holder for mains fuse 13 Connection for mains cable 16 Connector for ultrasound head 0.8 / 2.4 MHz 18 Label Note: For Soleo Sono the sockets (14 *), (15 *) and (17 *) have no function.
  • Page 6 Explanation of Symbols Soleo Sono Ultrasound heads Fig. 5 Ultrasound head, large Ultrasound head, small...
  • Page 7 Explanation of Symbols In the instructions for use, this symbol indicates “Danger”. Caution! In the instructions for use, this symbol represents "Caution" with regard to damage of the device. Device Type BF Follow the instructions for use Instructions for Use Serial number Item number Manufacturer...

  • Page 8: Table Of Contents

    Contents Explanation of Symbols Soleo Sono Front panel Display/ Navigation bars Rear panel / Switches and connector sockets Ultrasound heads Explanation of Symbols Page Indications / Contraindications Side Effects Application Information 3.1 General 3.2 Ultrasound heads Warnings Soleoline – in brief...
  • Page 9 Legal Notices Error Message, Troubleshooting, Disposal Manufacturer's EMC Declaration Valid for Soleo Sono. These instructions for use are an integral part of the device. It must be stored with the device and kept accessable at all times for anyone to operate this device.

  • Page 10: Indications / Contraindications

    Indications / Contraindications 1.1 Indications Indications from Spinal pain syndromes, e.g. cervical spine syndrome • orthopaedics, surgery, Ankylosing spondylitis (only in inflammation-free intervals) • traumatology, Joint disorders • rheumatology Rheumatoid arthritis (if heat treatment is indicated) • Arthrosis • Periarthropathies •...
  • Page 11 Indications / Contraindications 1.2 Contraindications General • Vague pain symptoms Contraindications • Diseases where heat should not be used, for example, acute inflammatory diseases • Diseases where mechanical impacts are contraindicated, e.g. deep vein thrombosis, • Restricted blood flow • Suspected diseases of the cardiovascular system •...

  • Page 12: Side Effects

    Side Effects Side effects of If used correctly, no side effects are known. ultrasound therapy Page 3...

  • Page 13: Application Information

    Inspect the device before use. If damaged, it must not be used. Only accessories provided by Zimmer MedizinSysteme GmbH are to be used and no Caution other devices must be connected.

  • Page 14: Ultrasound Heads

    Application Information 3.2 Ultrasound Handle the ultrasound head carefully, as rough handling can alter its properties. Do not bring the ultrasound head into contact with sharp or pointed objects, as the aluminium head is susceptible to scratching. The use of couplant other than the special Sono plus ultrasound gel can damage the ultrasound head.

  • Page 15: Warnings

    Warnings This product is intended for use by medical professionals only. Users of the device must be trained in the correct use of the system and must possess the appropriate skills. The use of this product with settings or for applications other than those specified in the user manual may lead to hazards resulting from the uncontrolled release of ultrasonic energy.

  • Page 16: Soleoline - In Brief

    Soleoline – in brief What is Soleoline? An ultra-modern innovative product line that provides 3 different device variants. Soleo Sono A cutting-edge, innovative ultrasound therapy device. Soleo SonoStim A state of the art, innovative combination device for electrotherapy and ultrasound therapy, with the option of the additional use of a vacuum unit.

  • Page 17: Intended Use

    Intended Use The Soleoline product range includes 3 different device versions: Soleo Sono Ultrasound therapy device for treatment with therapeutic ultrasound. Soleo SonoStim Combination device for ultrasonic therapeutic treatment and electrotherapy, with the option of the additional use of a vacuum unit.

  • Page 18: Device Set Up

    7 Device Set up 7.1 Installation of Cables Note: There are coloured arrows located on the cables as a guide for proper connection to the device. Ultrasound therapy Connect the ultrasound head to the appropriate socket (16). Connect the mains Connect the mains cable to the appropriate socket (13) and connect the cable to cable the mains.

  • Page 19: Basic Settings

    Basic Settings 8.1 General Note: The following descriptions are based on the default settings. Note: Changes to the basic settings can only be made from the start up screen. Start up Screen Once the device has been switched on and the self-test performed, the start up screen opens.
  • Page 20 Basic Settings 8.1 General Language Selecting the language The selection is made directly in the corresponding row. Program start up Adjustment of the program start up settings. settings The selection is made directly in the corresponding row. Startup screens Choice of two start up screens. The selection is made directly in the corresponding row.
  • Page 21 Basic Settings 8.1 General Brightness Adjustment of screen brightness from 0 to 10. The adjustment is made using the two arrow keys. Screensaver Adjustment of screen saver start time, from 0-20 minutes. The adjustment is made using the two arrow keys. Note: The screensaver function is disabled when therapy is in progress.

  • Page 22: Ultrasound Therapy

    Basic Settings 8.2 Ultrasound Therapy Settings Activating the menu Ultrasound therapy opens the "Ultrasound therapy configuration selection" screen. Coupling signal Adjustment (50 to 95%) of the coupling limits value. The adjustment is made using the two arrow keys. Unit Adjustment of unit intensity on the bar graph. The selection is made directly in the corresponding row.

  • Page 23: Maintenance

    Basic Settings 8.3 Maintenance Maintenance opens the "maintenance Configuration Selection" screen. In the maintenance menu, software updates can be performed. You will receive the latest information about performing a software update when an update is planned. To open the maintenance menu, enter the password "armin". Page 14...

  • Page 24: Operating Instructions

    Here the desired programme may be selected. Programmes of Soleo Sono In Soleo Sono there are 9 different programmes available Programme selection The desired ultrasonic therapy program is selected directly in the corresponding row (in this case US 01).
  • Page 25 Operating Instructions 9.1 Ultrasound therapy Therapy screen After selecting the ultrasound therapy program, the therapy screen opens. Note: Before starting treatment, check that the data in the parameter window (in this case 5 cm²) corresponds with the connected ultrasound head. Adjusting the intensity Adjust the intensity using the left intensity controller.
  • Page 26 Operating Instructions 9.1 Ultrasound therapy Therapy startup Pressing button starts the therapy. When therapy starts, the display in the bottom status bar changes from "Ready" to “Active "and the "Start" button changes to "Stop". In the bar graph, the configured dose is displayed and the therapy time counts down at one-second intervals.

  • Page 27: Displays/Buttons

    Operating Instructions 9.2 Displays/Buttons Description of the display elements and buttons (1) Intensity The bar graph displays the currently set intensity. The intensity is adjusted using the left controller. (2) Start / Stop Pressing the button starts or stops the therapy. (3) Penetration The bar graph shows the current frequency ratio, ranging from 0.8 MHz (800 kHz) to 2.4 MHz, as a percentage.

  • Page 28: Water Bath Treatment

    Operating Instructions 9.3 Water Bath Treatment Note: If ultrasound therapy is performed in a water bath, the temperature monitoring of the ultrasound head must be modified prior to therapy. Performance Touching the pulse button opens the ultrasound parameters window. Pressing the water By touching the water bath button bath button and confirming with "OK", temperature monitoring of the ultrasound head is modified...

  • Page 29: Sd Card

    Operating Instructions 9.4 SD Card SD card Custom settings and the list of indications are saved on the SD card. Note: If the SD card is not inserted, the message "No SD card found" will appear when you press the "Indications", "Favourites" and "Memory" buttons. Deactivate the message as described in Chapter 18.
  • Page 30 Operating Instructions 9.5 Indication Menu The indication menu is used to assist in the choice of therapy. Selecting a region of the A region of the body is selected by clicking the blue circle. body Selecting a symptom After selecting the desired region of the body (in this case the shoulder), the indications window opens, that lists various diseases affecting the shoulder area.

  • Page 31: Indication Menu

    Operating Instructions 9.5 Indication Menu Therapy information After selecting the differentiated clinical picture, another window opens with detailed therapy information and a program recommendation. Selecting the therapy program Touching button opens the therapy screen with the corresponding programme. Page 22...

  • Page 32: Storing Programs

    Operating Instructions 9.6 Storing Programs Note: In order to save programs, the SD card must be properly inserted into the SD card slot. If this is not the case, it is not possible to save programs. Opening the memory list and naming a program Touching button opens the keyboard to enable the entry of the programme...
  • Page 33 Operating Instructions 9.6 Storing Programs Saving to the Favourites list / Memory list Touching button (1) opens the favourites list and automatically saves the program in the favourites list. Pressing button (2) opens the memory list and saves the program in the memory list. Touching the "OK"...

  • Page 34: Run Programs / Editing Lists

    Operating Instructions 9.7 Run Programs / Editing lists Individually saved programs are listed in the favourites list. Here these can be called up in order to implement therapy or edited (the sequence altered or deleted). Note: The steps to retrieve and editing the favourites / memory list are identical; therefore only the retrieve and editing of the favourites list is described.
  • Page 35 Operating Instructions 9.7 Run Programs / Editing lists Editing favourites The programme to be processed is selected directly in the corresponding row. Touching button (1) returns you to the favourites list. Touching button (2) scrolls the program up. Touching button (3) scrolls the program down. Touching button (4) deletes the program.

  • Page 36: Technical Information

    Technical Information 10.1 General Mains voltage 100 - 240 V / 50 Hz / 60 Hz 220 V / 60 Hz Mains fuse 2 x T2AL, 250 V, 5x20 mm Electrical energy max. 60 VA consumption Protection class Applied Part Type BF Operating mode Intermittent operation: 30 minutes on, 10 minutes off...

  • Page 37: Ultrasound

    Technical Information 10.2 Ultrasound Ultrasound heads Frequency 0.8 MHz and 2.4 MHz Ultrasound head, small 1 cm² , ERA = 0.67 cm² at 0.8 MHz, 0.65 cm² at 2.4 MHz Maximum power 1.0 W at 0.8 MHz, 0.6 W at 2.4 MHz Intensity levels 0.1 to 1 W/cm²...

  • Page 38: Cleaning Disinfection

    Cleaning Disinfection - Before starting any cleaning and maintenance measures, the device must always be switched off at the main switch and unplugged. - Make sure that during cleaning and disinfection no liquids penetrate the device. Do not use sprays. - If liquid penetrates the device during cleaning or disinfecting, please put the unit out of service, protect it from getting used again and contact your service representative.

  • Page 39: Ce- Mark/Manufacturer

    The product bears the CE-mark in accordance with EC Directive 93/42/EEC concerning medical devices. Manufacturer Zimmer MedizinSysteme GmbH Junkersstraße 9 89231 Neu-Ulm, Germany Tel. +49 731. 9761-291 Fax: +49 731. 9761-299 www.zimmer.de Page 30...

  • Page 40: Scope Of Delivery Accessories

    Scope of delivery Accessories Scope of delivery Soleo Sono Art. No. 5312 1 basic device Soleo Sono 1 ultrasound head 0.8 and 2.4 MHz, ø 28 mm 1 tray mount, right 1 tray mount, left 1 mains cable 2 touch pens...

  • Page 41: Device Combinations

    Device Combinations The Soleo Sono device is not intended for combination with other devices. If the operator combines devices (medical system), then the operator has the sole responsibility for ensuring correct assembly. Page 32...

  • Page 42: Safety And Maintenance

    Safety and Maintenance Soleo Sono is manufactured according to the EN 60601-1 safety regulations. As the manufacturer, Zimmer MedizinSysteme can only be considered responsible for safety and reliability if the equipment is operated using a proper power outlet with an earthing contact and •...

  • Page 43: Function Test

    Function Test Soleo Sono performs a self-test when switched on to check all the internal components. In the event of a fault, an error message appears. In addition, an extended function test can be performed as described below. These tests should be performed monthly or in case of any doubt regarding the correct function of the device.

  • Page 44: Legal Notices

    Safety Check (STK) Metrological Controls (MTK) The Soleo Sono device is not listed in Annex 1 of MPBetreibV (Medical Device Operating Directive). The device is not listed in Annex 2 of MPBetreibV (Medical Device Operating Directive). In Germany, the DGUV regulation 3 (Electrical Systems and Equipment) in its current version must also be observed.

  • Page 45: Error Message, Troubleshooting, Disposal

    Neu-Ulm. The device must be returned to the factory in its original packaging. For questions or equipment malfunctions, please contact the address listed: Headquarters Zimmer MedizinSysteme GmbH Junkersstraße 9 89231 Neu-Ulm, Germany Tel. +49 731. 9761-291 Fax: +49 731. 9761-299 www.zimmer.de...

  • Page 46: Manufacturer's Emc Declaration

    Portable and mobile RF communications equipment (e.g. mobile phones) can affect electrical medical equipment. Soleo Sono may only be operated with the original parts specified in the list of parts and accessories included within the scope of delivery. The operation of the device with other parts may result in increased emissions or in the device's decreased interference immunity.
  • Page 47 Guidelines and manufacturer's declaration - electromagnetic immunity The Soleo Sono device is intended for use in an electromagnetic environment, as specified below. The customer or the user of the Soleo Sono device should ensure that it is used in such an environment.
  • Page 48 Guidelines and manufacturer's declaration - electromagnetic immunity The Soleo Sono device is intended for use in an electromagnetic environment, as specified below. The customer or the user of the Soleo Sono device should ensure that it is used in such an environment.
  • Page 49 RF transmitters, a study of the electromagnetic phenomena at the location should be considered. If the measured field strength in the location in which the Soleo Sono device is used exceeds the above compliance level, the Soleo Sono device must be monitored to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as the realignment or relocation of the Soleo Sono device.
  • Page 52 Soleoline Instructions for Use Zimmer MedizinSysteme GmbH Junkersstraße 9 D-89231 Neu-Ulm Tel. +49 7 31. 97 61-291 Fax +49 7 31. 97 61-299 export@zimmer.de www.zimmer.de...

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