Zimmer Soleoline Soleo Sono, Operating Instructions Manual

Page 1: ...Operating Instructions Soleoline Soleo Sono GB ...

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Page 3: ... control elements 1 Intensity regulator 4 Screen 2 Frequency ratio regulator 5 Touch pen in holder 3 Slot for ultrasound head 6 SD card slot Fig 2 Screen readouts 7 Status bar 9 Title bar 8 Navigation bar 10 Buttons on the screen 1 2 3 4 5 3 6 9 8 10 7 ...

Page 4: ...device 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 11 12 15 16 14 17 13 ...

Page 5: ...10 4 Quick operating instructions 11 4 1 Water bath treatment 15 5 General instructions SD card 17 6 Description of the selection buttons 18 7 Screenshot of the therapy screen 22 8 Description of the screen elements and the buttons 8 1 Screen elements 23 8 2 Buttons 26 9 Indications menu 29 10 Saving a modified programme 32 10 1 Favourites 34 10 2 Memory 35 11 Retrieving and editing favourites and...

Page 6: ...delivery accessories 48 20 Safety and maintenance 49 21 Functional test 50 22 Error messages Troubleshooting Disposal 51 23 Manufacturer s EMC declaration 52 Valid for the Soleo Sono device These Operating Instructions are an integral part of the device They must be stored with the device and kept accessible at all times for anyone authorised to operate this device These Operating Instructions are...

Page 7: ...ine A clear contemporary colour screen showing all parameters necessary for therapy as well as modern touch control Individual programme start configuration and clear simple menu navigation make operation of the device easy and comfortable for users The compact design saves room in the practice and is highly suited for use in house visits What does the Soleo Sono do Delivers therapeutic ultrasound...

Page 8: ... ensure that the green arrow is pointing left when being plugged in Connect the ultrasound head to the appropriate socket 14 Connecting the mains cable Plug the mains cable into the appropriate socket 11 on the device and then plug into the mains socket Switching on the device Switch on the device using the rocker switch 13 Note All buttons menus and submenus are activated directly on the screen b...

Page 9: ...Note Changes to the default settings can only be made from the start screen Start screen After switching on the device and the self test the start screen opens Selecting configuration Press the button to open the configuration menu ...

Page 10: ...active Saving settings Press the button to save the new settings Closing the configuration menu Press the button to return to the start screen General settings The setting options are outlined below In the factory the default settings are pre programmed as shown on the screen Language Press the arrow key to open the drop down menu to select the language The language is selected by pressing on the ...

Page 11: ...ton to open the drop down menu to select the programme start configurations The selection is made by pressing on the appropriate row Start screen Option to choose between 2 start screens Press the arrow button to open the drop down menu to select the start screen The selection is made by pressing on the appropriate row ...

Page 12: ...witch sounds on and off The selection is made by pressing on the appropriate row Volume Option to adjust the volume in steps from 1 to 4 Press the arrow button to open the window to adjust the volume The volume is adjusted using both arrow keys Brightness Option to adjust the screen brightness in steps from 0 to 10 The brightness is adjusted using both arrow keys ...

Page 13: ...n saver after 0 to 20 minutes The start time is adjusted using both arrow keys Note While therapy is running the screen saver function is deactivated Welcome message Option to configure an individual welcome message Press the field to open the screen keyboard to enter a welcome message ...

Page 14: ...1 General 3 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: ...d for therapy can be adjusted here Coupling signal Option to adjust 50 to 95 the threshold for coupling The threshold is adjusted using both arrow keys Units Option to configure the units for intensity in a bar graph Press the arrow button to open the drop down menu to select the desired units for power The selection is made by pressing on the appropriate row ...

Page 16: ...se the keyboard to insert the password To open the update menu enter the password armin 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: ...ick operating instructions 4 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: ... therapy programme by pressing on the appropriate row here US 01 Therapy screen After selecting the ultrasound therapy programme the therapy screen opens Note Check that the information shown on the Parameter button here 5 cm2 matches the ultrasound head connected before starting therapy ...

Page 19: ...frequency ratio using the right hand regulator Starting therapy Press the button to start the therapy The display in the bottom status bar changes from Ready to Active with the start of therapy and the Start button changes to Stop The dose set is shown in the bar graph and the therapy time counts down in seconds The coupling display is active ...

Page 20: ...y has 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 to Ready The therapy time is automatically reset and the Stop button changes to Start at the end of the therapy ...

Page 21: ...asound head temperature monitoring must be changed before starting the therapy Implementation Press the Pulse button to open the Ultrasound Parameters window Pressing Water bath button By pressing the Water bath button and confirming with OK the ultrasound head temperature monitoring is modified for therapy in a water bath ...

Page 22: ...y deactivated Continuing therapy in the water bath Press the button Ending therapy in the water bath Press the button Note Once therapy in the water bath is complete the temperature of the ultrasound head may be too high for treatment outside the water bath This is shown in the status bar by the message Ultrasound head temperature adjustment The ultrasound head cannot be used while the temperature...

Page 23: ...fined settings and the indications list are saved on the 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: ...ess the button to open the settings menu The options are described in detail in Section 3 Start Press the button to open the start screen from the Programme window Favourites Press the button to open Favourites for editing to add the programme to Favourites in memory mode Programmes Press the button to open the Programmes window ...

Page 25: ...editing to add the programme to the memory list in memory mode Saving Press the button to open the screen to save a programme The Save button can only be pressed from the therapy screen Back Press the button to go back one screen Editing Press the button to open the Memory screen to edit the memory list to open the Favourites screen to edit Favourites ...

Page 26: ...by one position Moving Press the button to move the order of the list downwards by one position Deleting Press the button to delete the selected programme from the list Scrolling forwards Press the button to scroll one page down the list Scrolling backwards Press the button to scroll one page up the list ...

Page 27: ...ns 6 Close Press the button to close the Favourites and Memory programmes Cancel Press the button to reject the changes made OK Press the button to confirm the changes in the selected list OK The changes are applied by pressing the button ...

Page 28: ...22 Screenshot of the therapy screen 7 ...

Page 29: ...ws 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 Parameters Shows the active ultrasound head Pulse Shows the operating mode selected ...

Page 30: ...howing the pulse ratio 1 2 here and the pulse frequency 50 Hz here Depth effect The bar graph shows the current frequency ratio of 0 8 MHz 800 kHz to 2 4 MHz as a percentage In this example 25 2 4 MHz 75 0 8 MHz 800 kHz For further explanation please consult the Therapy Manual Adjusting frequency ratio Adjust the percentage frequency ratios of 2 4 MHz to 0 8 MHz using the right hand regulator ...

Page 31: ...as a percentage 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 In this case Set a new coupling value and when the coupling is sufficient the therapy will continue Bar graph Shows the currently specified intensity ...

Page 32: ...s 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 Activating the Pulse button When the Pulse button is activated the Ultrasound Parameters window is opened Ultrasound parameters The ultrasound mode can be selected here and the ultrasound head can be switched to therapy in a water bath ...

Page 33: ...select the desired mode Modes continuous pulsed with duty cycles of 1 2 1 3 1 5 and 1 10 Selecting the frequency Press the two arrow buttons to select the desired frequency Frequencies 20 Hz 50 Hz and 100 Hz Water bath Press the button to switch the ultrasound head temperature monitoring to therapy in a water bath ...

Page 34: ...28 Description of the screen elements and buttons 8 2 Buttons 8 Saving Press the button to save the modified parameters Cancelling changes Press the button to reject changes made ...

Page 35: ...9 Indications menu 9 The Indications menu helps you to select the therapy Indications Press the button to open the Indications menu Selecting by body region Select a body region by touching a blue circle ...

Page 36: ...s symptoms in the shoulder region Select the symptoms by clicking on the relevant row shoulder arm syndrome in this example Selecting by detailed symptoms After selecting the symptoms another window opens showing detailed symptoms Select the detailed symptoms by clicking on the relevant row painful tendinous insertion sites and tendons in this example ...

Page 37: ...y information After selecting the detailed symptoms another window opens showing detailed therapy information and a suggested programme Selecting the therapy programme Press the button to open the therapy screen with the programme ...

Page 38: ...a modified programme 10 As described in the previous sections the programme parameters can be separately modified and saved Selecting the programme Changing the parameters The changes are displayed on the screen ...

Page 39: ...e name Naming the programme Two options are available for naming a programme 1 Accept the programme name in the input field 2 Enter a custom programme name If using a custom name use the keyboard to enter the programme name Note When entering a custom programme name the name in the input field must first be deleted ...

Page 40: ...ogramme in Favourites Press the button to open Favourites Adding the programme to Favourites Press the button to add the programme to Favourites The programme is automatically saved in the first free space in the list F Favourites 00 Programme number in the list ...

Page 41: ...ogramme in the Memory Press the button to open the Memory Adding the programme to the Memory Press the button to add the programme to the Memory The programme is automatically saved in the first free space in the list S Memory 00 Programme number in the list ...

Page 42: ...The individual saved programs are listed in Favourites From here they can be 1 retrieved for therapy or 2 edited sequence changed or deleted Selecting Favourites Press the button to open Favourites Selecting therapy Select the desired programme by pressing on the appropriate row ...

Page 43: ...s 11 Editing Favourites Press the button to open the Edit Favourites screen Selecting the programme Select the programme to be edited by clicking on the appropriate row Changing sequence Activate the appropriate arrow keys to move the programme up or down in the sequence ...

Page 44: ...d editing favourites and memory 11 2 Editing favourites 11 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: ...g Memory Pressing the button to open the Memory Selecting therapy Select the desired programme by pressing on the appropriate row Editing Memory Note The following steps to edit the Memory correspond exactly to those used to edit Favourites that were described in detail in the preceding section ...

Page 46: ... Periarthropathy Epicondylopathy Tendinosis periostitis heel spurs Achillodynia Scars contractures Dupuytren s contracture Posttraumatic disorders Fractures particularly with delayed callus formation Other indications Bronchial asthma Rhinopathy Persistent cervical spine complaints after whiplash injuries with repetitive blocking Headaches Earaches Postherpetic neuralgia Functional disorders of th...

Page 47: ...t apply ultrasound higher than C3 Do not apply ultrasound to parenchymatous or heat sensitive organs testes eyes pregnant uterus liver kidney etc Anaesthetised skin areas Temperature regulation disorders After treatment with ionising radiation Epiphyseal plates and lines Tumours Do not use over electronic pacemakers Metal implants and endoprostheses There are no longer any concerns about dynamic u...

Page 48: ...nstructions 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 Use on hearts is prohibited The device is Class II IEC or double insulated ...

Page 49: ...es Handle the ultrasound head carefully as rough treatment may alter its properties Do not bring the ultrasound head into contact with sharp or pointed objects as the aluminium head is easily scratched Disinfect the ultrasound head with standard disinfectants after use The use of coupling agents other than the special ultrasound gel Sono plus may damage the ultrasound head We recommend Sono plus b...

Page 50: ...mption max 60 VA Protection class II 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 in original packaging only Operational environment 10 C to 40 C 30 to 75 rel humidity 700 1060 hPa Storage 10 C to 50 C 10 to 90 rel humidity 700 1060 hPa ...

Page 51: ...ERA 2 3 cm at 800 kHz 0 8 MHz 4 cm at 2 4 MHz Maximum output 7 W at 800 kHz 0 8 MHz 10 W at 2 4 MHz Intensity steps 0 1 to 3 W cm eff in steps of 0 1 W cm Accuracy 20 This value represents the legally permissible value required by law and not the actual accuracy level for each device Ultrasound modes 1 Continuous ultrasound 2 Pulsed ultrasound adjustable pulse frequencies 20 Hz 50 Hz 100 Hz Duty f...

Page 52: ...ble for plastic Screen Clean the screen with standard alcohol free plastic cleaner Disinfect the screen with standard alcohol free disinfectant suitable for plastic Ultrasound heads Clean the ultrasound heads with tap water Disinfect the ultrasound heads with standard alcohol free disinfectant suitable for plastic Do not use cleaning agents containing alcohol ...

Page 53: ...l 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 Soleo Sono has been developed manufactured and tested under the ISO 13485 quality management system ...

Page 54: ... 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 13 mm 118 Mains cable 65910320 Storage tray right 65910310 Storage tray left 6 Sono plus 1 bottle ...

Page 55: ...ood repair before using it before every use check the ultrasound head cables and connectors for damage such as cracks that could adversely affect the safety of the device the device must be operated by appropriately trained personnel only disconnect the device from the power supply immediately if it is exposed to liquids the unit is not designed for use in explosive or inflammable environments The...

Page 56: ... 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 Select ultrasound head and cover the ultrasound head with gel The coupling display must show over 90 at low power and at the start of therapy Run the test consecutively using both ultrasound heads Then clean ultrasound heads ...

Page 57: ...ng five seconds and switching it on again 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 Head office Zimmer MedizinSysteme GmbH Junkersstraße 9 D 89231 Neu Ulm Tel 49 731 9761 291 Fax 49 731 9761 299 www zimmer de...

Page 58: ...gnetic environments specified below The customer or the user of the Soleo Sono should assure that it is used in such an environment Emissions tests Compliance Electromagnetic environment guidance RF emissions CISPR 11 Group 2 The Soleo Sono device must emit electromagnetic energy in order to perform its intended function Nearby electronic equipment may be affected RF emissions CISPR 11 Class B Har...

Page 59: ...erential mode 2 kV common mode 1 kV differential mode 2 kV common mode The quality of the supply voltage should correspond to a typical business or hospital environment The quality of the supply voltage should correspond to a typical business or hospital environment 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT for 5 sec 5 UT 95 ...

Page 60: ...quipment should be used no closer to any part of Soleo Sono including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d 1 17 P d 0 35 P for 80 MHz to 800 MHz d 0 7 P for 800 MHz to 2 5 GHz where P is the maximum output power rating of the transmitter in Watts W according to the transmitter m...

Page 61: ...bances are controlled The customer or user of the Soleo Sono device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the device as recommended below according to the maximum output power of the communications equipment Separation distance according to frequency of transmitter m Rated maximum out...

Page 62: ...B Version 2 03 2011 Right of modifications reserved Soleoline 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 Operating Instructions ...