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Zimmer Soleoline Soleo Sono Operating Instructions Manual

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Operating Instructions
Soleoline
Soleo Sono
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Summary of Contents for Zimmer Soleoline Soleo Sono

  • Page 1 Operating Instructions Soleoline Soleo Sono...
  • Page 3 Soleo Sono Front view of device Fig. 1 Selection and control elements 1 Intensity regulator Screen 2 Frequency ratio regulator Touch pen in holder 3 Slot for ultrasound head SD card slot Fig. 2 Screen readouts 7 Status bar Title bar 8 Navigation bar 10 Buttons on the screen...
  • Page 4 Fig. 3 Soleo Sono Rear view of device (15*) (16*) (17*) Switch and connector sockets 11 Connector for mains cable 13 On/off switch 12 Fuse holder for mains fuse 14 Socket for 0.8/2.4 MHz ultrasound head Note: Sockets (15*), (16*) and (17*) have no function on Soleo Sono.

  • Page 5: Table Of Contents

    Contents Soleo Sono Front view of device Selection and control elements/screen readouts Rear view of device Switch and connector sockets Page Soleoline – Summary / Soleo Sono Fitting the cables, Starting the system Configuration General Ultrasound therapy Attendance/Maintenance Quick operating instructions Water bath treatment General instructions –...
  • Page 6 Contents Page Indications Contraindications Explanation of symbols Warnings Technical Information 16.1 General 16.2 Specific Cleaning, Disinfection CE Marking Contents on delivery, accessories Safety and maintenance Functional test Error messages, Troubleshooting, Disposal Manufacturer's EMC declaration Valid for the Soleo Sono device. These Operating Instructions are an integral part of the device.

  • Page 7: Soleoline - Summary / Soleo Sono

    Soleoline – Summary Soleo Sono An ultramodern and innovative range of products with 3 different devices What is Soleoline? available. Soleo Sono An ultramodern and innovative ultrasound therapy device. Soleo SonoStim An ultramodern and innovative combination device for electrotherapy and ultrasound therapy with the option of attaching a vacuum unit.

  • Page 8: Fitting The Cables Starting The System

    Fitting the cables Starting the system Note: On the connector cable for the ultrasound head there is a green arrow as a guide for correct connection with the device. When connecting the ultrasound head, ensure that the green arrow is pointing Connecting the left when being plugged in.

  • Page 9: Configuration

    Configuration 3.1 General Note: Changes to the default settings can only be made from the start screen. After switching on the device and the self-test, the start screen opens. Start screen Selecting configuration Press the button to open the configuration menu.
  • Page 10 Configuration 3.1 General In the configuration menu the factory settings can be changed and individually Configuration menu set. After activation of the configuration menu the ‘Choice of Configuration’ screen is active. Saving settings Press the button to save the new settings.
  • Page 11 Configuration 3.1 General Configuration options for the programme start settings: Start settings Press the arrow button to open the drop-down menu to select the programme start configurations. The selection is made by pressing on the appropriate row. Option to choose between 2 start screens: Start screen Press the arrow button to open the drop-down menu to select the start screen.
  • Page 12 Configuration 3.1 General To switch the signal sound on and off when activating the control fields: Sounds Press the arrow button to open the drop-down menu to switch sounds on and off. The selection is made by pressing on the appropriate row. Option to adjust the volume in steps from 1 to 4: Volume Press the arrow button...
  • Page 13 Configuration 3.1 General Option to configure the start of the screen saver after 0 to 20 minutes: Screen saver The start time is adjusted using both arrow keys. Note: While therapy is running, the screen saver function is deactivated. Option to configure an individual welcome message. Welcome message Press the field to open the screen keyboard to enter a welcome message.
  • Page 14 Configuration 3.1 General Setting defaults Press the button to reset the factory standard settings. Version Press the button to open the window with information about the current software version. Press the OK button to close the window.

  • Page 15: Ultrasound Therapy

    Configuration 3.2 Ultrasound therapy Activate the menu Ultrasound therapy settings to open the ‘Ultrasound therapy configuration’ screen. The settings required for therapy can be adjusted here. Option to adjust (50 to 95%) the threshold for coupling: Coupling signal The threshold is adjusted using both arrow keys. Option to configure the units for intensity in a bar graph: Units Press the arrow button...

  • Page 16: Attendance/Maintenance

    Software can be updated using the updates menu. You will receive the latest information about updating software when an update is planned. For Servicing other passwords are necessary. Servicing is permissible by Zimmer technicians or technicians trained by Zimmer only.

  • Page 17: Quick Operating Instructions

    Quick operating instructions Starting the programme Press the button to open the ‘Programme’ screen. The programme is selected here. Soleo Sono programmes There are 9 different programmes available in Soleo Sono.
  • Page 18 Quick operating instructions Select the desired ultrasound therapy programme by pressing on the Selecting the appropriate row (here US 01). programme After selecting the ultrasound therapy programme, the therapy screen opens. Therapy screen Note: Check that the information shown on the Parameter button (here 5 cm matches the ultrasound head connected before starting therapy.
  • Page 19 Quick operating instructions Adjust the intensity using the intensity controller on the left. Setting intensity Note: Change the percentage frequency ratio using the right hand regulator. Press the button to start the therapy. Starting therapy The display in the bottom status bar changes from ‘Ready’ to ‘Active’ with the start of therapy and the ‘Start’...
  • Page 20 Quick operating instructions At the end of the therapy time an acoustic signal indicates that the therapy has Ending therapy ended and the clock is reset to 00:00. The intensity automatically returns to zero, the bar graph display disappears and the coupling display is inactive. The display in the bottom status bar changes from ‘Active’...

  • Page 21: Water Bath Treatment

    Quick operating instructions 4.1 Water bath treatment Note: If the ultrasound therapy is done in a water bath, the ultrasound head temperature monitoring must be changed before starting the therapy. Press the Pulse Implementation button to open the ‘Ultrasound Parameters’ window. By pressing the ‘Water bath’...
  • Page 22 Quick operating instructions 4.1 Water bath treatment If at the end of the therapy an additional treatment with the same ultrasound programme will be carried out, after adjusting the intensity the following message appears: If at the end of therapy the programme will be changed, the function of the water bath button is automatically deactivated.

  • Page 23: General Instructions - Sd Card

    General instructions SD card User-defined settings and the indications list are saved on the SD card. SD card Note: If the SD card is not inserted, the message ‘No SD card found’ appears when the Indications, Favourites and Memory buttons are pressed. Deactivate the message as described in Section 22.

  • Page 24: Description Of The Selection Buttons

    Description of the selection buttons Note: The following descriptions are all based on the factory settings. Press the button to open the settings menu. Configuration The options are described in detail in Section 3. Press the button to open the start screen from the Programme window. Start Press the button Favourites...
  • Page 25 Description of the selection buttons Press the button to open the indications menu. Indications Press the button Memory • to open the memory list for editing • to add the programme to the memory list in memory mode. Press the button to open the screen to save a programme. Saving The ‘Save’...
  • Page 26 Description of the selection buttons Press the button to move the order of the list upwards by one position. Moving Press the button to move the order of the list downwards by one position. Moving Press the button to delete the selected programme from the list. Deleting Press the button to scroll one page down the list.
  • Page 27 Description of the selection buttons Press the button to close the Favourites and Memory programmes. Close Press the button to reject the changes made. Cancel Press the button to confirm the changes in the selected list. The changes are applied by pressing the button.

  • Page 28: Screenshot Of The Therapy Screen

    Screenshot of the therapy screen...

  • Page 29: Description Of The Screen Elements And The Buttons

    Description of the screen elements and buttons 8.1 Screen elements Title bar The title bar shows the current ultrasound therapy programme. Status bar The status bar shows information on the current status of the therapy. If the therapy is not active, it shows the word ‘Ready’. During therapy, it shows the word ‘Active’.
  • Page 30 Description of the screen elements and buttons 8.1 Screen elements Graphic view of the operating mode Operating mode Pulse ratio continuous Pulse frequency pulsed Pulsed operating mode showing the pulse ratio (1:2 here) and the pulse frequency (50 Hz here). The bar graph shows the current frequency ratio of 0.8 MHz (800 kHz) to 2.4 Depth effect MHz as a percentage.
  • Page 31 Description of the screen elements and buttons 8.1 Screen elements The coupling is shown digitally as a percentage. Coupling Important: The most beneficial coupling value is 100%. If the coupling is below the preset value (factory setting 75%), an acoustic signal sounds and the therapy time is paused.

  • Page 32: Buttons

    Description of the screen elements and buttons 8.2 Buttons Note: If the Pulse button is activated during therapy, the therapy will be interrupted, the intensity returns to zero and the therapy time is set to the standard value. Note: Only the parameters that are shown in the pulse window can be changed. When the ‘Pulse’...
  • Page 33 Description of the screen elements and buttons 8.2 Buttons Press the two arrow buttons Selecting the mode to select the desired mode. Modes: • continuous • pulsed with duty cycles of 1:2, 1:3, 1:5 and 1:10 Press the two arrow buttons Selecting the frequency to select the desired frequency.
  • Page 34 Description of the screen elements and buttons 8.2 Buttons Press the Saving button to save the modified parameters. Press the Cancelling changes button to reject changes made.

  • Page 35: Indications Menu

    Indications menu The Indications menu helps you to select the therapy. Press the Indications button to open the ‘Indications’ menu. Select a body region by touching a blue circle. Selecting by body region...
  • Page 36 Indications menu After selecting the desired body region (shoulder in this example) the Selecting by Indications window opens showing various symptoms in the shoulder region. symptoms Select the symptoms by clicking on the relevant row (shoulder-arm syndrome in this example). After selecting the symptoms another window opens showing detailed Selecting by symptoms.
  • Page 37 Indications menu After selecting the detailed symptoms another window opens showing Therapy information detailed therapy information and a suggested programme. Press the Selecting the therapy programme button to open the therapy screen with the programme.

  • Page 38: Saving A Modified Programme

    Saving a modified programme As described in the previous sections, the programme parameters can be separately modified and saved. Selecting the programme The changes are displayed on the screen. Changing the parameters...
  • Page 39 Saving a modified programme Press the Opening the memory list button to open the screen to enter the programme name. Two options are available for naming a programme. Naming the programme 1. Accept the programme name in the input field. 2.

  • Page 40: Favourites

    Saving a modified programme 10.1 Favourites Press the Saving a programme in Favourites button to open Favourites. Press the Adding the programme to Favourites button to add the programme to Favourites. The programme is automatically saved in the first free space in the list. Favourites Programme number in the list...

  • Page 41: Memory

    Saving a modified programme 10.2 Memory Press the Saving a programme in the Memory button to open the Memory. Press the Adding the programme to the Memory button to add the programme to the Memory. The programme is automatically saved in the first free space in the list. Memory Programme number in the list...

  • Page 42: Retrieving And Editing Favourites And Memory

    Retrieving and editing favourites and memory 11.1 Retrieving favourites The individual saved programs are listed in Favourites. From here they can be: retrieved for therapy or edited (sequence changed or deleted). Press the Selecting Favourites button to open Favourites. Select the desired programme by pressing on the appropriate row. Selecting therapy...

  • Page 43: Editing Favourites

    Retrieving and editing favourites and memory 11.2 Editing favourites Press the Editing Favourites button to open the ‘Edit Favourites’ screen. Select the programme to be edited by clicking on the appropriate row. Selecting the programme Activate the appropriate arrow keys to move the programme up or down in Changing sequence the sequence.
  • Page 44 Retrieving and editing favourites and memory 11.2 Editing favourites Deleting a programme Pressing the button triggers the security question ‘Delete’. Press the button to delete the programme. Press the button to keep the programme.

  • Page 45: Retrieving And Editing Memory

    Retrieving and editing favourites and memory 11.3 Retrieving and editing memory Pressing the Selecting Memory button to open the Memory. Select the desired programme by pressing on the appropriate row. Selecting therapy Editing Memory The following steps to edit the Memory correspond exactly to those used to Note: edit Favourites that were described in detail in the preceding section.

  • Page 46: Indications

    Indications • Vertebral pain syndrome, e.g., cervical syndrome Indications for • Anyklosing spondylitis orthopaedics, surgery, (only during inflammation-free periods) traumatology, rheumatology • Joint diseases • Rheumatoid arthritis (if heat treatment is indicated) • Joint degeneration • Periarthropathy • Epicondylopathy • Tendinosis, periostitis, heel spurs •...

  • Page 47: Contraindications

    Contraindications • Diseases in which heat should not be applied, e.g., acute inflammatory General diseases contraindications • Diseases in which mechanical forces are contraindicated, e.g., phlebothrombosis, haemorrhagic diathesis • Do not apply ultrasound higher than C3 • Do not apply ultrasound to parenchymatous or heat-sensitive organs (testes, eyes, pregnant uterus, liver, kidney, etc.) •...

  • Page 48: Explanation Of Symbols

    Explanation of symbols In the Operating Instructions, this symbol stands for danger. Follow directions in the Operating Instructions at all times. In the Operating Instructions this symbol stands for ‘Caution’ with regard to possible material damage. Follow Operating Instructions Manufacturer Serial number Type BF (as per IEC 601-1): Degree of protection against electric shock.

  • Page 49: Warnings

    The use of coupling agents other than the special ultrasound gel Sono plus may damage the ultrasound head. We recommend Sono plus by Zimmer MedizinSysteme GmbH. This device is exclusively for use by qualified medical personnel. This device may cause malfunctioning in or may interfere with the operation of devices in its vicinity.

  • Page 50: Technical Information

    Technical Information 16.1 General Operating voltage 100–240 V, 220 V / 50/ 60 Hz Power consumption max. 60 VA Protection class Mains fuse 2 x 3.15 A T Applied part Type BF Dimensions 322 mm x 234 mm x 130 mm Weight 2.1 kg Transport...

  • Page 51: Specific

    Technical Information 16.2 Specific Ultrasound heads Frequency 800 kHz (0.8 MHz) and 2.4 MHz Small ultrasound head 1 cm² , ERA = 1.1 cm² at 800 kHz (0.8 MHz), 0.5 cm² at 2.4 MHz Maximum output 1 W at 800 kHz (0.8 MHz), 0.5 W at 2.4 MHz Intensity steps 0.1 to 1 W/cm²...

  • Page 52: Cleaning Disinfection

    Cleaning Disinfection Clean housing with standard alcohol-free plastic cleaner. Housing Disinfect the housing with standard alcohol-free disinfectant suitable for plastic. Clean the screen with standard alcohol-free plastic cleaner. Screen Disinfect the screen with standard alcohol-free disinfectant suitable for plastic. Clean the ultrasound heads with tap water. Ultrasound heads Disinfect the ultrasound heads with standard alcohol-free disinfectant suitable for plastic.

  • Page 53: Ce Marking

    CE Marking The products bear the CE marking in accordance with EU Medical Devices Directive 93/42/EEC and meets the essential requirements of Annex I to this Directive. The product Soleo Sono is rated in Class IIb according to Annex IX of the Directive.

  • Page 54: Contents On Delivery Accessories

    Contents on delivery Accessories Soleo Sono Contents on delivery 1 variable frequency ultrasound head 0.8 and 2.4 MHz, ø 28 mm 1 storage tray, right 1 storage tray, left 1 mains cable 2 touch pens Accessories Item No. 4100 Variable frequency ultrasound head 0.8 and 2.4 MHz, ø 28 mm 4101 Variable frequency ultrasound head 0.8 and 2.4 MHz, ø...

  • Page 55: Safety And Maintenance

    Soleo Sono is produced in accordance with the safety requirements of EN 60601-1. Zimmer MedizinSysteme as the manufacturer can be responsible for the safety and reliability only in the following circumstances: • if the device is operated from an approved earthed wall socket and the electrical installation conforms to DIN VDE 0100 Part 710 •...

  • Page 56: Functional Test

    Functional test Soleo Sono runs a self-test that checks all internal components after it is switched on. An error message is shown in case of faults. An extended functional test can also be run as described below. These tests should be run once a month or if there is any doubt about the operational reliability of the device.

  • Page 57: Error Messages Troubleshooting Disposal

    If this does not work, contact customer service. Customer service is reached through your authorised sales representative or by contacting the head office in Neu-Ulm. The device must be sent to the factory in the original packaging only. Zimmer MedizinSysteme GmbH Head office Junkersstraße 9 D-89231 Neu-Ulm Tel.

  • Page 58: Manufacturer's Emc Declaration

    Manufacturer's EMC declaration Medical electrical devices such as Soleo Sono are subject to special precautions with regard to electromagnetic compatibility (EMC) and must be installed and commissioned in accordance with the EMC advice given in the operating instructions and accompanying documents. Portable and mobile RF communications devices (such as mobile telephones) may interfere with medical electrical devices.
  • Page 59 Manufacturer's EMC declaration Guidance and manufacturer's declaration – electromagnetic immunity The Soleo Sono device is intended for use in one of the electromagnetic environments specified below. The customer or the user of the Soleo Sono device should ensure that it is used in such an environment. Immunity tests IEC 60601 test level Compliance level...
  • Page 60 Manufacturer's EMC declaration Significant performance characteristics of the Soleo Sono are: interference-free delivery of ultrasound, as well as interference-free operation of all functions with the parameters set. Guidance and manufacturer's declaration – electromagnetic immunity The Soleo Sono device is intended for use in one of the electromagnetic environments specified below. The customer or the user of the Soleo Sono device should ensure that it is used in such an environment.
  • Page 61 Manufacturer's EMC declaration Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast, cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered.
  • Page 62 Soleoline Operating Instructions Zimmer MedizinSysteme GmbH Junkersstraße 9 D-89231 Neu-Ulm Tel. +49 731. 97 61-291 Fax +49 731. 97 61-299 export@zimmer.de www.zimmer.de...

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