Zimmer Soleo Galva Operating Instructions Manual Download Page 4

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Fig. 3

Soleo

SonoStim

/ Soleo

Galva

Rear view of device

Switch and connector sockets

12 Connector for mains cable

16 Socket for electrode cable channel II

13 Fuse drawer for mains fuse

17 Socket for 0.8/2.4 MHz ultrasound head

14 On/off switch

18 Socket for electrode cable channel I

15 Socket without function in Soleo

line

Summary of Contents for Soleo Galva

Page 1: ...Operating Instructions Soleoline Soleo SonoStim Soleo Galva Soleo VacoS GB ...

Page 2: ......

Page 3: ...ts 1 Intensity controller channel I 5 Screen 2 Intensity controller channel II 6 Touch pen in holder 3 Alligator clip option 7 SD card slot 4 Slot for ultrasound head Fig 2 Screen readouts 8 Status bar 10 Title bar 9 Navigation bar 11 Buttons on the screen 1 2 3 4 5 4 7 10 9 11 8 3 6 ...

Page 4: ...tor sockets 12 Connector for mains cable 16 Socket for electrode cable channel II 13 Fuse drawer for mains fuse 17 Socket for 0 8 2 4 MHz ultrasound head 14 On off switch 18 Socket for electrode cable channel I 15 Socket without function in Soleoline 12 13 15 14 16 17 18 ...

Page 5: ...ckets Circuit I 1 Connector socket Vaco electrode sleeve black cathode 2 Connector socket Vaco electrode sleeve red anode Circuit II 3 Connector socket Vaco electrode sleeve black cathode 4 Connector socket Vaco electrode sleeve red anode 1 2 4 3 ...

Page 6: ...e cable Channel II 6 Connector for mains connector cable 10 Socket for connecting cable with SonoStim I Galva channel II 7 Connector for mains cable 11 Socket for electrode cable channel I 8 Fuse holder for mains fuse 12 Socket for connecting cable with SonoStim I Galva channel I 5 6 7 8 9 10 11 12 ...

Page 7: ...Soleo SonoStim Soleo Galva and VacoS Side view Fig 6 13 Connector valve for water separator 13 ...

Page 8: ...ary 1 2 Fitting the cables starting the system 2 1 Soleo SonoStim Soleo Galva 2 2 2 VacoS 3 3 Configuration 3 1 General 6 3 2 Electrotherapy 12 3 3 Ultrasound therapy 14 3 4 Maintenance 16 4 Soleo SonoStim Quick operating instructions 4 1 Electrotherapy 17 4 2 Ultrasound therapy 21 4 2 1 Water bath treatment 25 4 3 Combination therapy 27 5 Soleo Galva Quick operating instructions 31 6 Soleo SonoSt...

Page 9: ...12 2 Description of the parameter button 63 12 3 Description of the treatment depth button 66 13 Combination therapy Screenshot of the therapy screen 67 14 Electrotherapy with VacoS Screenshot of the therapy screen 68 14 1 Description of the screen elements 69 14 2 Changing parameters 70 15 Indications menu 73 16 Saving a modified programme 76 16 1 Favourites 78 16 2 Memory 79 17 Retrieving and ed...

Page 10: ...s electrode types 115 29 CE Marking 117 30 Contents on delivery accessories 30 1 Soleo SonoStim 118 30 2 Soleo Galva 119 30 3 VacoS 120 31 Device combinations 121 32 Safety and maintenance 122 33 Functional test 123 34 Safety checks 124 35 Error messages Troubleshooting Disposal 125 36 Manufacturer s EMC declaration 130 Valid for Soleo SonoStim Soleo Galva and VacoS devices These Operating Instruc...

Page 11: ...ages of Soleoline 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 combination of electrotherapy and ultrasound therapy in a single system enables the use of the established combination therapy The c...

Page 12: ... II into the appropriate socket 16 Attach the red alligator clip to the red connector on the electrode cable Attach the black alligator clip to the black connector on the electrode cable Ultrasound therapy When connecting the ultrasound head ensure that the green arrow is pointing left when being plugged in when standing at the back of the device Connect the ultrasound head to the appropriate sock...

Page 13: ...the device Fig 4 Connecting VacoS with SonoStim Galva When fitting the connection cable ensure that the green arrow is pointing downwards when connecting the cable to Soleo SonoStim Soleo Galva 18 When fitting the connection cable ensure that the green arrow is pointing upwards when connecting the cable to VacoS 12 Channel I Plug the connecting cable into the appropriate sockets on Soleo SonoStim ...

Page 14: ...ate socket 9 on VacoS Attach the red alligator clip to the red connector on the electrode cable Attach the black alligator clip to the black connector on the electrode cable Installation of Vaco electrode sleeves Plug the black Vaco electrode sleeve into the appropriate socket 1 on the front of VacoS here I Plug the red Vaco electrode sleeve into the appropriate socket 2 on the front of VacoS here...

Page 15: ... appropriate sockets on VacoS 6 and Soleo SonoStim Soleo Galva 12 Connecting the mains cable Plug the mains cable into the appropriate socket on VacoS 7 and then plug the cable into the mains power wall socket Switching on VacoS Switch on VacoS using the rocker switch 5 Note Press this icon to activate VacoS The window is only active if VacoS is switched on and the devices are connected to one ano...

Page 16: ...a single channel and are based on the factory default settings 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 17: ...tive Saving settings Press the button to save the new settings Quitting 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 a...

Page 18: ...o open the drop down menu to select the programme start configurations The options are selected by pressing on the appropriate row Start screen Option to choose between 2 start screens Press the arrow key to open the drop down menu to select the start screen The start screen is selected by pressing on the appropriate row ...

Page 19: ...witch sound 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 key 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 20: ...r after 0 to 20 minutes The time is selected using both arrow keys Note While therapy is running the screen saver function is deactivated Welcome message Option to configure an individual welcome message Activate the Welcome message field to open the screen keyboard to enter a welcome message ...

Page 21: ...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 22: ...ation screen The settings required for therapy can be adjusted here Time Option to configure a uniform therapy time of 1 to 60 minutes for all programmes The time is selected using both arrow keys Polarity cycle Option to adjust the polarity reversal time from 10 to 120 seconds The time is selected using both arrow keys ...

Page 23: ...z and 8000 Hz The frequency is selected using both arrow keys Note The device is preset with a base frequency of 8000 Hz If you modify the base frequency in this menu the name of programmes MF00 to MF11 will remain with 8000Hz The programmes themselves will work with the frequency selected in this menu ...

Page 24: ...gs is only possible in the Soleo SonoStim version Ultrasound therapy settings Press the menu to open the Ultrasound therapy configuration screen The settings required 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 ...

Page 25: ...rasound therapy 3 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 unit is selected by pressing on the appropriate row ...

Page 26: ...board 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 MedizinSysteme only ...

Page 27: ...ging the therapy time can result in a modification of the effects and the patient must be carefully monitored during treatment Starting the programme Press the button to open the Programme screen The programme is selected here SonoStim programme There are 3 different programmes available in SonoStim Electrotherapy Ultrasound therapy Combination therapy ...

Page 28: ...ng electrotherapy Electrotherapy is selected by pressing on the appropriate row The following description refers to the electrotherapy programme Selecting current forms group Select the current forms group by pressing on the appropriate row here monophasic rectangular current ...

Page 29: ...ing instructions 4 1 Electrotherapy 4 Selecting current form Select the current form by pressing on the appropriate row here LF 00 Therapy screen After selecting the current form the therapy screen opens automatically for channel I ...

Page 30: ...rapy time counts down in seconds Ending therapy At the end of the therapy time an acoustic signal indicates that the therapy has ended the clock is reset to 00 00 the intensity automatically returns to zero and the bar graph display disappears The display in the bottom status bar changes from Active to Ready The therapy time is automatically reset at the end of the therapy Note The Vacuum icon is ...

Page 31: ...g instructions 4 2 Ultrasound therapy 4 Starting the programme Press the button to open the Programme screen The programme is selected here Selecting ultrasound therapy Ultrasound therapy is selected by pressing on the appropriate row ...

Page 32: ... desired ultrasound 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 33: ...nsity controller on the left 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 34: ...tes that the therapy 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 35: ...e ultrasound head temperature monitoring must be changed before starting the therapy Implementation Press the Parameters 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 36: ...s automatically 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 t...

Page 37: ...ng instructions 4 3 Combination therapy 4 Starting the programme Press the button to open the Programme screen The programme is selected here Selecting combination therapy Select combination therapy by pressing on the appropriate row ...

Page 38: ... instructions 4 3 Combination therapy 4 Selecting the programme Select the desired combination therapy programme by pressing on the appropriate row Therapy screen After selecting the combined therapy programme the therapy screen opens ...

Page 39: ...ller on the right Setting intensity of stimulation current The display in the bottom status bar changes from Ready to Active In the left bar graph the adjusted ultrasound dose is shown and the coupling display is active In the right bar graph the actual current flow is shown The therapy time counts down in seconds Note With combination therapy always ensure that the conducting electrode cable anod...

Page 40: ...ustic signal indicates that the therapy 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 at the end of the therapy ...

Page 41: ... the button to open the Programme screen Selecting current forms group Select the current forms group by pressing on the appropriate row here monophasic rectangular current Note The additional steps required to carry out the therapy are described in more detail in Section 4 1 ...

Page 42: ...is analogous to that described in Section 4 1 Electrotherapy Note If a vacuum unit is not attached the Vacuum button is not displayed This is also the case if data transmission or the connection of the vacuum unit to Soleo SonoStim Soleo Galva is broken or interrupted Opening the Vacuum menu Press the button to open the Vacuum menu ...

Page 43: ...rodes By activating the base vacuum the vacuum is active In the bar graph the value of the base vacuum is shown Note The factory setting is continuous mode Press the Mode button to open the input window Vacuum to set the pulsed operating mode A detailed description can be found in Section 14 2 Selecting vacuum Set the intensity of the vacuum using both the arrow keys In the bar graph the current v...

Page 44: ...therapy starts The effective current is shown in the bar graph and the therapy time counts down in seconds Ending electrotherapy At the end of the therapy time an acoustic signal indicates that the therapy has ended the clock is reset to 00 00 the intensity automatically returns to zero and the bar graph display disappears The display in the bottom status bar changes from Active to Ready The thera...

Page 45: ...a Quick operating instructions Electrotherapy with VacoS 6 Note The vacuum must be ended manually using Stop after expiry of the time The Stop button changes to Start Deactivating the vacuum Deactivate the vacuum using the button ...

Page 46: ...sage Empty water separator appears on the screen If the water separator is not emptied therapy cannot be started Empty the water separator as described in Section 35 SD card User defined 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 mes...

Page 47: ...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 48: ...utton to open the channel mode When the button is pressed different channel mode options can be selected Mode Group Activates Monostim 1 channel therapy The exceptions are pre programmed dual channel currents e g interference currents Activates Twinstim 2 channel therapy The same 1 channel current form runs on channel 1 and channel 2 Activates Duostim 2 channel therapy Different 1 channel current ...

Page 49: ...s defined here for the Twinstim and Duostim modes Alternate activation The current forms are started and stopped simultaneously on both channels The surges are alternate Parallel activation The current forms are started and stopped simultaneously on both channels The surges are simultaneous Separate activation The current forms are started and stopped separately on both channels The surges are ind...

Page 50: ...e Both buttons are highlighted in channel mode and can only be activated in Duostim 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 51: ...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 52: ...ns 8 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 53: ...43 Electrotherapy Screenshots of the various therapy screens 9 Monostim Example Programme LF00 on one channel I Twinstim Example Programme LF00 on both channels I and II ...

Page 54: ...44 Electrotherapy Screenshots of the various therapy screens 9 Duostim alternating Duostim parallel Duostim separate ...

Page 55: ...us 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 Effects Gives an overview of the associated medical effects of analgesia hyperaemia relaxation and strengthening of the current form Note If the waveform parameters pulse time or pulse pause are changed the effects of the current ...

Page 56: ...graph of intensity Shows the currently specified intensity In CC mode display in mA eff or peak In CV mode display in V peak Vacuum 1 Indicates on the therapy screen that the vacuum unit is connected 2 Opens after activation of the vacuum settings and start screen The parameters can be set and the vacuum unit started here Note If a vacuum unit is not connected this button is not visible ...

Page 57: ...n 10 4 1 1 Frequency display 1 2 Graphic view of waveform 1 3 Polarity 1 4 CC CV 1 5 Galvanic component Note Modes 1 3 1 5 cannot be used with all current forms and are therefore not always displayed 1 1 Frequency display The frequency modes are shown differently depending on the current form e g single frequency base frequency variable frequency Two frequencies with an animated display of the cur...

Page 58: ...y negative polarity reverses automatically Note If the polarity reverses automatically the first polarity reversal is for 45 seconds factory setting or the time set in the configuration menu 1 4 CC CV Indication of constant current or constant voltage constant current constant voltage 1 5 Galvanic component Indication of the galvanic component 0 20 50 ...

Page 59: ...n see Section 10 5 Note If the Surge icon is activated during therapy the therapy will be interrupted and the intensity will be set to zero The therapy time is stopped The therapy is restarted for the remaining time by adjusting the intensity Surge deactivated When the surge is deactivated the surge window is shown in minimised form After activation of the surge window the surge can be activated a...

Page 60: ...therapy the surge is shown as an animation showing the surge position Synchronisation mode alternated Alternating In two channel mode the alternating surge mode is shown by the two opposing arrows in the top left corner Synchronisation mode parallel Parallel In two channel mode the parallel surge mode is shown by the two parallel arrows in the top left corner ...

Page 61: ...to zero and the therapy time is set to the standard value Activating the Parameters button When the Parameters button is activated the Parameters of Current Form window is opened Parameters of current form Adjustable parameters can be changed by the user here 1 Pulse and pulse pause time of current form and therefore the frequency 2 Galvanic component 3 CC CV 4 Polarity The adjustable parameters a...

Page 62: ... changed are selected with the arrow keys The parameter highlighted in blue can be changed impulse time here Note Changes to the pulse and pulse hold time also change the frequency Changing parameters Use the arrow keys to increase or decrease the value within the limits specified in the current form definition ...

Page 63: ...nent or to eliminate the galvanic component Switching CC CV mode Press the arrow keys to switch the current form from CC to CV mode and vice versa Changing polarity Press the arrow keys to change the polarity of the current form In mode the polarity inversion will be made automatically every 45 seconds default value preset in the Configuration Menu ...

Page 64: ...54 Electrotherapy 10 4 Change current form parameters 10 Saving parameters Press the button to save the modified parameters Cancelling changes Press the button to reject changes ...

Page 65: ...dard value Activating Surge button When the Surge button is activated the Surge Parameters window is opened Surge parameters The surge parameters can be modified as follows by the user Surge rise time 0 s surge off Shortest rise time 0 5 s Longest rise time 60 s Shortest hold time 0 s Longest hold time 60 s Shortest fall time 0 2 s Longest fall time 5 s Shortest pause time 0 2 s Longest pause time...

Page 66: ...time Selecting parameters Select the parameters to be changed using the arrow keys 1 Rise time 1 5 s here 2 Hold time 4 0 s here 3 Pause time 12 s here The parameter highlighted in blue can be changed rise time here Changing parameters Use the arrow keys to increase or decrease the value within the limits specified in the surge parameters definition ...

Page 67: ...57 Electrotherapy 10 5 Change surge parameters 10 Saving parameters Press the button to save the modified parameters Cancelling changes Press the button to reject changes ...

Page 68: ...rameters window is activated the Parameters of Current Form window is opened Parameters of current form Adjustable parameters can be changed by the user here 1 Base frequency 4000 Hz here and modulation frequency 10 Hz here Adjustable base frequencies 2500 Hz 4000 Hz and 8000 Hz 2 Percentage ratio of channel I and channel II intensity 95 here Adjustable from 0 100 in 5 steps Note The intensity is ...

Page 69: ...59 Ultrasound therapy Screenshot of the therapy screen 11 ...

Page 70: ...ormation 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 1 Displays data from the connected ultrasound head and the programme parameters 2 Opens the Parameters window A detailed description can be found in Section 12 2 1 1 Ultrasound head and size of ultrasound head 1 2 Operating mode pulse frequency pulse...

Page 71: ... here 1 2 Operating mode Pulse ratio Pulse frequency Graphic view of the operating mode continuous or pulsed Pulsed operating mode showing the pulse ratio 1 3 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 75 2 4 MHz 25 0 8 MHz 800 kHz ...

Page 72: ... 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 73: ...to zero and the therapy time is set to the standard value Note Only the parameters that are shown in the parameter window can be changed Activating the parameter button When the Parameter window 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 74: ... 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 75: ...65 Ultrasound therapy 12 2 Description of the parameter button 12 Saving Press the button to save the modified parameters Cancelling changes Press the button to reject changes made ...

Page 76: ...n is activated during therapy the therapy will be interrupted the intensity returns to zero and the therapy time is set to the standard value Adjusting treatment depth Press the Depth of treatment button to open the treatment depth screen Adjust the frequency ratios 0 8 MHz to 2 4 MHz using both arrow keys ...

Page 77: ...Note The buttons and functions on the Combination therapy screen correspond exactly to the therapy screens for Electrostimulation and Ultrasound therapy as described in the previous sections An extensive description of the therapy screen will not be given here ...

Page 78: ...s have been described in detail in the preceding sections and only the displays and buttons that are also active when using VacoS will be described in this section Electrotherapy combined with VacoS Note The Vacuum button can only be activated from the therapy screen of a programme in the Electrotherapy group ...

Page 79: ...ot displayed This is also the case if data transmission or the connection of the vacuum unit to SonoStim Soleo Galva is broken or interrupted Parameters The display shows the parameters of the factory settings 1 View of base vacuum as bar graph 2 Operating mode continuous here 3 Numeric display of base vacuum Activation of the base vacuum The bars in the bar graph show the activation of the base v...

Page 80: ... Changing vacuum parameters Press the button to open the vacuum menu to set the vacuum parameters Continuous mode The factory setting is continuous mode Pulse mode Adjust the pulse duration using both arrow keys The pulse time can be set from 0 5 s to 8 0 s ...

Page 81: ...he base vacuum using the arrow keys to the left and right of the Base Vacuum window Note If the base vacuum is set higher than 16 kPa the vacuum must be increased first An increase in the base vacuum above 16 kPa is then possible Vacuum Adjust the vacuum using both arrow keys next to the Vacuum window ...

Page 82: ...4 2 Changing parameters 14 Saving parameters Press the button to save the changed parameters and to return to the Vacuum start screen Cancelling changes Press the button to reject the changes and to return to the Vacuum start screen ...

Page 83: ... Indications menu 15 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 84: ...howing various 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 subacute pain status in this example ...

Page 85: ...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 86: ...mme parameters can be separately modified and saved Note The procedure for saving is similar for all therapy forms The save procedure for an electrotherapy programme is described below Selecting the programme Changing the parameters The change is shown in the title bar LF 01 modified ...

Page 87: ...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 88: ...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 89: ...rogramme in the Memory Press the button to open the Memory Adding the programme to the Memory Press the button to add the program 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 90: ...he individual saved programmes 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 91: ...es 17 Editing Favourites Press the button to open the Edit Favourites screen Selecting the programme Select the program 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 92: ...diting favourites and memory 17 2Editing favourites 17 Deleting a programme Pressing the button triggers the security question Delete Press the button to delete the saved program Press the button to keep the saved program ...

Page 93: ...ing Memory Press 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 94: ... Currents programmes for sports rehabilitation They generally consist of warm up training and relaxation phases Therapy screen for a preset programme Sequence display The currently active sequence 1 to 3 is shown in a field Therapy time A therapy time is specified for all three phases The top number shows the remaining time for the current phase The bottom number shows the total remaining time ...

Page 95: ... starting the therapy Activating the sequence window Press the field to open the Sequences window Before starting the sequence therapy the intensity surges are defined here for the individual sequences Defining intensities Sequence 1 Warm up phase Sequence 1 is highlighted in blue and is active Confirm sequence 1 with OK Define the intensity for sequence 1 using the two intensity buttons ...

Page 96: ... muscle strengthening Press the field to open the Sequences window Select sequence 2 by clicking on the row It is highlighted in blue after activation Confirm sequence 2 with OK Define the intensity for sequence 2 using the two intensity buttons ...

Page 97: ...row It is highlighted in blue after activation Confirm sequence 3 with OK Define the intensity for sequence 3 using the two intensity buttons Note After defining the intensities the therapy time runs through the various sequences When the next sequence is selected the predefined intensity of the previous sequence is automatically saved ...

Page 98: ...sequence 1 Press the field to open the Sequences window Activate sequence 1 by directly pressing on the row and confirm with OK By activating sequence 1 the therapy time is reset to the predefined value and the start button becomes active ...

Page 99: ... Starting therapy Click the button to start the therapy The three sequences run in succession The change of sequence is indicated by an acoustic signal Ending therapy When the therapy time has finished an acoustic signal sounds ...

Page 100: ...nge medium frequency innervation test PA 01 Neofaradic test PA 02 Chronaxia accommodation quotient PA 03 Fischgold test Various programmes with all the pulse shapes suitable for paralysis therapy are available The parameters can be modified for the patient depending on the medical history Therapy programmes PA 06 Paralysis treatment with triangular impulse currents alternating PA 07 Paralysis mode...

Page 101: ...ating the intensity the Pulse button becomes active Implementation Trigger a single pulse by setting an appropriate intensity and pressing the button Then the test is repeated on healthy muscle If the two muscles have approximately the same excitability to the single pulse the muscle in question is innervated If there are significant differences in the reaction of the muscles to high excitation in...

Page 102: ...ated A muscle is normally innervated if it reacts with a contraction equal in length to an excitation time of one minute An innervation disorder can be assumed if no contraction or only a short contraction is observed Screenshot Implementation The excitation time is started at one minute by regulating the intensity ...

Page 103: ...ich the accommodation quotient is calculated Screenshot Rheobase Surge current magnitude for triggering a minimum muscle twitch with a square wave pulse of 1000 ms Implementation Calculating rheobase Step 1 Set an appropriate low intensity Step 2 Trigger a single pulse Repeat steps 1 and 2 with increasing intensity until a minimum muscle twitch is observed The rheobase value is calculated using th...

Page 104: ...ty cannot be modified in this step Chronaxie Pulse duration for triggering a minimum muscle twitch at a surge current strength that is double the rheobase value Calculating chronaxia Step 1 Increase pulse time in stages or reduce if required Step 2 Trigger a single pulse Repeat steps 1 and 2 until a minimum muscle twitch is observed The chronaxie value is calculated using the first minimum muscle ...

Page 105: ...commodation quotient Surge intensity mA of the RPC at 1000ms rheobase TPC triangular pulse characteristic RPC rectangular pulse characteristic Calculating accommodation threshold Step 1 Set an appropriate low intensity Step 2 Trigger a single pulse Repeat steps 1 and 2 with increasing intensity until a minimum muscle twitch is observed The accommodation threshold is calculated using the first mini...

Page 106: ...a 0 05 ms Hyperexcitability 0 05 1 ms Normal excitability 1 20 ms Partial degeneration 20 ms Complete degeneration Normal chronaxia values according to Edel Anterior muscles front of body Proximal 0 08 0 16 ms Distal 0 16 0 32 ms Posterior muscles back of body Proximal 0 16 0 32 ms Distal 0 44 0 72 ms Evaluation of the accommodation quotient according to Edel 6 3 normally functioning neuromuscular...

Page 107: ... phase 2 the intensity I2 of the first muscle twitch is calculated for a square wave pulse of 100 ms The quotient FGq I1 I2 is shown as the result Screenshot Conducting measurement phase 1 Step 1 Set an appropriate low intensity Step 2 Trigger a single pulse Repeat steps 1 and 2 with increasing intensity until a minimum muscle twitch is observed Step 3 Accept measured value By accepting the measur...

Page 108: ... phase 2 in the same way as phase 1 After the measurement the calculated values are shown at the top right of the screen Evaluation of the quotients 1 7 normally functioning neuromuscular system 1 7 partial degeneration If one of the two intensities cannot be calculated the degeneration is complete ...

Page 109: ...int disease chronic Radicular syndrome in spinal diseases subacute and chronic Ligament ruptures Tendovaginitis Bursitis Analgesic therapy Distortions contusions muscular tendon and joint sprains Widespread myalgia Polyarthralgia Joint diseases inflammatory Chronic polyarthritis rheumatoid arthritis treatment during low inflammation periods Diffuse pain in periarthropathy arthritis Bechterew s dis...

Page 110: ... Myofascial pain syndrome Tendon and muscle ruptures Contractures Other indications Periarthropathy and insertion tendinopathy acute subacute Periarthropathy and insertion tendinopathy chronic Peripheral joint disease acute subacute Posttraumatic stress disorders haematoma oedema Excessive sweating on the hands and feet palmar plantar hyperhidrosis Acquired curvature of the spine posttraumatic pos...

Page 111: ...estinal motility disorder Chronic constipation Secondary lymphoedema and lymph stasis Pelvipathy Polyneuropathy Anterior horn cell disease of the spinal cord Peripheral paralysis plexus paralysis Non local generalised spinal cord diseases Spasticity Spastic paralysis Flaccid paralysis ...

Page 112: ...is indicated Joint degeneration Periarthropathy Epicondylopathy Tendinosis periostitis heel spurs Achillodynia Scars contractures Dupuytren s contracture Posttraumatic disorders Fractures particularly with delayed callus formation Bronchial asthma Rhinopathy Persistent cervical spine complaints after whiplash injuries with repetitive blocking Headaches Earaches Postherpetic neuralgia Functional di...

Page 113: ...redominantly psychogenic pain TENS therapy is ineffective Central pain syndrome e g thalamic pain syndrome Additional contraindications Muscular treatment with surged pulse groups surging currents is contraindicated with unconsciousness clouding of consciousness reflex inhibition such as with fractures muscular inflammation mimetic facial muscles if the electrostimulation therapy triggers sustaine...

Page 114: ...thesis Do not 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 abo...

Page 115: ...structions at all times In the Operating Instructions this symbol stands for Caution with regard to possible damage to property 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 116: ...y devices may cause oscillations in the output values of the electrotherapy device Please maintain a safe distance of several metres The recommended maximal current density for currents that could cause burns e g galvanic current diadynamic currents current with a galvanic component is 2 mA eff cm electrode surface If the current density exceeds 2 mA eff cm users must be extremely vigilant during ...

Page 117: ...ent 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 by Zimmer MedizinSysteme Vacuum Do not conduct treatment...

Page 118: ... Power consumption 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 119: ...ng plate Power consumption max 50 VA Protection class II Mains fuse 2 x 0 5 A T Applied part Type BF Dimensions 322 mm x 234 mm x 130 mm Weight 3 0 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 120: ...xx CC 250 mApeak 250 mApeak 250 mApeak 250 mApeak CV 40 Vpeak 140 Vpeak 200 Vpeak 200 Vpeak Medium frequency currents MF xx CC 56 mA 56 mA 56 mA 56 mA CV 10 V 25 V 60 V 60 V Interference currents IF xx CC 56 mA 56 mA 56 mA 56 mA CV V V V V Microstimulation currents MI xx CC 1 mApeak 1 mApeak 1 mApeak 1 mApeak CV 0 3 Vpeak 0 6 Vpeak 1 Vpeak 2 Vpeak Low frequency rectangular currents NF xx CC 10 mAp...

Page 121: ... 5 cm 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 ...

Page 122: ...gative pressure 12 60 kPa Pulse operation Period duration adjustable from 1 to 8 s in steps of 0 5 seconds duty factor 1 1 Accuracy 20 This value represents the legally permissible value required by law and not the actual accuracy level for each device ...

Page 123: ...nd heads with tap water Disinfect the ultrasound heads with standard alcohol free disinfectant suitable for plastic Vaco electrodes Clean the suction cups with tap water with standard cleaners detergent added Any residue on the electrodes can be removed with the help of a hard brush if needed Disinfect the electrodes with standard alcohol free disinfectant suitable for plastic Sponge holders Rinse...

Page 124: ... rubber bands or Velcro Please note that rubber electrodes may quickly lose conductivity when used with monophase currents Insert the electrodes fully into the sponge holders and apply to the body with light pressure ensuring complete contact The fasteners should not leave any marks The electrical connection to the electrical cable terminals is similar to that with disposable electrodes Attach ter...

Page 125: ...cally sensible sizes allow individual therapy appropriate for the symptoms Disposable electrodes are particularly well suited to therapy with bipolar currents for therapy with monopolar pulsed currents or currents with a galvanic component the disposable electrodes should also be cushioned with a moist sponge Note The disposable electrode is intended for single use only and can be disposed of in h...

Page 126: ... is recommended to use sponge holders for rubber electrodes and sponges which should be at least 1 to 2 cm thick for zinc plate electrodes Tap water is recommended to moisten the sponges distilled water is not suitable as it is a poor conductor Unlike the comfortable self adhesive disposable electrodes rubber and zinc plate electrodes must be fixed in place Velcro or perforated rubber bands are su...

Page 127: ... The product Soleo SonoStim is rated in Class IIb according to Annex IX of the Directive The product Soleo Galva is rated in Class IIa according to Annex IX of the Directive The product VacoS is rated in Class IIa according to Annex IX of the Directive Soleo SonoStim Soleo Galva VacoS have been developed manufactured and tested under the ISO 13485 quality management system ...

Page 128: ...lligator clip black 21 Disposable electrodes 135 pairs small 1 package 22 Disposable electrodes 90 pairs medium 1 package 23 Disposable electrodes 45 pairs large 1 package 43 Plate electrodes 9 x 12 cm pure tin 96 Iontophoresis sponge 212 Membrane foil for iontophoresis 1 package Package 1000 units 180 x 120 cm 44 Rubber electrode 50 x 50 mm 1 pair 97 Sponge holder for 44 1 pair 46 Rubber electrod...

Page 129: ... 135 pairs small 1 package 22 Disposable electrodes 90 pairs medium 1 package 23 Disposable electrodes 45 pairs large 1 package 43 Plate electrodes 9 x 12 cm pure tin 96 Iontophoresis sponge 212 Membrane foil for iontophoresis 1 package Package 1000 units 180 x 120 cm 44 Rubber electrode 50 x 50 mm 1 pair 97 Sponge holder for 44 1 pair 46 Rubber electrode 50 x 100 mm 1 pair 98 Sponge holder for 46...

Page 130: ...connecting cables for Soleo SonoStim Soleo Galva 1 mains connecting cable short 4 sorting racks for Vaco electrode sleeves 1 water bottle Accessories Item No 95 Viscose sponge large for 72 94 Viscose sponge small for 71 72 Vaco electrode ø 90 mm self sealing 71 Vaco electrode ø 60 mm self sealing 164 Vaco electrode sleeves red 1 60 m long 165 Vaco electrode sleeve black 1 60 m long 68910210 Connec...

Page 131: ...121 Device combinations 31 Soleo SonoStim and Soleo Galva can be combined with VacoS The party that combines and uses the devices as a medical system is responsible for correct assembly of the devices ...

Page 132: ...ensions reconfigurations or modifications are implemented only by persons authorised by Zimmer MedizinSysteme users must ensure that the device is operating correctly and is in good 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 traine...

Page 133: ... graph must be completely full at maximum intensity Run the test consecutively with both channels Ultrasound 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 Vacuum Select vacuum and establish start vacuum Short circuit Vaco...

Page 134: ... observed when installing and operating the therapy devices Soleo SonoStim and Soleo Galva General information Store the Operating Instructions so they are accessible to operators of the device at all times Access must be available for inspection authorities at any time ...

Page 135: ...nals or a faulty patient fuse Press OK to clear the message Excess current This refers to an increase above the maximum allowable current A current increase in continuous mode generally indicates a fault in the device while a current increase in continuous voltage mode may occur because of a change in the patient resistance e g moist skin Press OK to clear the message If the error message appears ...

Page 136: ...ages Troubleshooting Disposal 35 No SD card found If the SD card is not inserted the message No SD card found appears when the Indications Favourites and Memory buttons are pressed Insert the card and confirm with OK ...

Page 137: ... attached and connected with a Vaco electrode Check that the Vaco electrodes are correctly applied to the patient Vacuum button deactivates If the Vacuum button deactivates there may be a transmission error In this case Check if Soleo SonoStim Soleo Galva are correctly placed on VacoS Check if Soleo SonoStim Soleo Galva are correctly attached to VacoS via the connecting cable Check if VacoS is swi...

Page 138: ...s suction which is used to empty the water separator Under some circumstances repeatedly creating suction is necessary to completely empty the water separator Disconnecting the bottle The bottle is removed from the connector valve by squeezing on the side of the quick release fastener on the tube of the water bottle and simultaneously withdrawing the connector The lid of the bottle is removed by t...

Page 139: ...ice can be contacted through your authorised sales representative or by contacting the head office in Neu Ulm Germany The device must be sent to the factory in the original packaging only Head office Zimmer MedizinSysteme GmbH Junkersstraße 9 89231 Neu Ulm Germany Tel 49 731 9761 291 Fax 49 731 9761 299 www zimmer de Disposal The device must be disposed of by an approved disposal company and must ...

Page 140: ...tic environments specified below The customer or the user of the Soleo SonoStim Soleo Galva device should ensure that the device is used in such an environment Emissions tests Compliance Electromagnetic environment guidance RF emissions CISPR 11 Group 2 The Soleo SonoStim Soleo Galva device must emit electromagnetic energy in order to perform its intended function Nearby electronic equipment may b...

Page 141: ...ferential 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 142: ...80 MHz 10 V m 80 MHz to 2 5 GHz Portable and mobile RF communications equipment should be used no closer to any part of Soleo SonoStim Soleo Galva 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 m...

Page 143: ... radiated RF disturbances are controlled The customer or user of the Soleo SonoStim Soleo Galva device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF telecommunications equipment transmitters and the Soleo SonoStim Soleo Galva device as recommended below according to the maximum output power of the communications equipment Separation ...

Page 144: ... 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 ...

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