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User Manual

Soleo

line

Soleo

SonoStim

, Soleo

Stim

User Manual

Soleo

SonoStim

, Soleo

Stim

USA

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Summary of Contents for Soleo Series

Page 1: ...User Manual Soleoline Soleo SonoStim Soleo Stim User Manual Soleo SonoStim Soleo Stim USA All manuals and user guides at all guides com a l l g u i d e s c o m ...

Page 2: ...r 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 All manuals and user guides at all guides com ...

Page 3: ...r 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 All manuals and user guides at all guides com ...

Page 4: ...al 6 3 2 Electrotherapy 7 3 3 Ultrasound therapy 8 4 Soleoline Summary 9 5 Fitting the cables starting the system 5 1 Soleo SonoStim Soleo Stim 10 6 Configuration 6 1 General 11 6 2 Electrotherapy 17 6 3 Ultrasound therapy 19 6 4 Maintenance 21 7 Soleo SonoStim Quick operating instructions 7 1 Electrotherapy 22 7 2 Ultrasound therapy 26 7 2 1 Water bath treatment 30 7 3 Combined therapy 32 8 Soleo...

Page 5: ... elements 61 14 2 Description of the parameter button 64 14 3 Description of the Frequency button 67 15 Combined therapy Screenshot of the therapy screen 68 16 Indications menu 69 17 Saving a modified programme 72 17 1 Fast Path 74 17 2 Memory 75 18 Retrieving and editing fast path and memory 18 1 Retrieving fast path 76 18 2 Editing fast path 77 18 3 Retrieving and editing memory 79 19 Explanatio...

Page 6: ...Stim 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 valid from 16 07 2012 U S A Federal Law restricts this device to sale by or on the order of a practitioner licensed by the law of the State in which he she practices to use or order th...

Page 7: ...ain Post surgical acute pain Indications for Medium Frequency Monophasic Currents Biphasic Symmetric Currents and High Voltage Relaxation of muscle spasm Increasing local blood circulation Prevention or retardation of disuse atrophy Maintaining or increasing range of motion Muscle re education Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis All manuals and user guid...

Page 8: ...nt contractures that may be associated with o Adhesive capsulitis o Bursitis with slight calcification o Myositis o Soft tissue injuries o Shortened tendons due to past injuries and scar tissues Relief of pain muscle spasms and joint contractures resulting from o Capsular tightness o Capsular scarring All manuals and user guides at all guides com ...

Page 9: ...fore operating this equipment The definition of these symbols are as follows Caution Text with Caution indicator will explain possible safety infractions that could have the potential to cause minor to moderate injury or damage to equipment Warning Text with Warning indicator will explain possible safety infractions that will potentially cause serious injury and equipment damage All manuals and us...

Page 10: ...r unless pain syndrome has been diagnosed Cautions Safety of powered muscle stimulators for use during pregnancy has not been established Some patients may experience skin irritation or hypersensitivity due to the electrical stimulation or electrical conductive medium The irritation can usually be reduced by using an alternate conductive medium or alternate electrode placement Electrode placement ...

Page 11: ...ntil bone growth is complete This device should not be used over a healing fracture This device should not be used over the thoracic area of any patient that has a cardiac pacemaker of any kind This device should not be used over the reproductive organs This device should not be used over or applied to the eye This device should not be used over the abdomen pelvic or lumbar regions of pregnant or ...

Page 12: ...lectrical service receptacle conforming to the applicable national and local electrical codes Before administering any treatment to a patient you should become acquainted with the operating procedures for each mode of treatment available as well as the indications contraindications warning and precautions Consult other resources for additional information regarding the application of electrotherap...

Page 13: ...isk of cardiac fibrillation When using different electrodes note that a smaller electrode surface area may result in a higher current density The long term effects of chronic electrical stimulation are unknown Stimulation should not be applied over the carotid sinus nerves particularly in patients with a known sensitivity to the carotid sinus reflex Stimulation should not be applied over the neck ...

Page 14: ...trasound device in the vicinity e g within 1 m of strong electromagnetic fields e g tomographs X ray or diathermy devices may interfere with the operation of the device Please maintain a safe distance of several metres 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...

Page 15: ...es 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 Combined therapy The compac...

Page 16: ...he 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 socket 17 Connecting the mains cable Plug the m...

Page 17: ...e 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 All manuals and user guides at all guides com ...

Page 18: ...ess 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 appropriate row All manu...

Page 19: ...re selected by pressing on the appropriate row Note This section will determine what screen the unit defaults to when Start is pressed from the Start Display screen Start display Option to choose between 2 start display screens Press the arrow key to open the drop down menu to select the start screen The selection is made by pressing on the appropriate row All manuals and user guides at all guides...

Page 20: ...election is made by pressing on the appropriate row Volume Option to adjust the volume in steps from 1 to 4 Press the arrow buttons 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 Press the arrow buttons to adjust the screen brightness All manuals and user guides at all guides com ...

Page 21: ...een saver is enabled Note While therapy is running the screen saver function is disabled Welcome message Option to configure an individual welcome message Activate the Welcome message field to open the screen keyboard to enter a welcome message Note Press for upper case letters and additional symbols All manuals and user guides at all guides com a l l g u i d e s c o m ...

Page 22: ... Press the button to reset the unit to the factory default settings Version Press the button to open the window with information about the current software version Press the OK button to close the window All manuals and user guides at all guides com ...

Page 23: ...r therapy can be adjusted here Time Option to configure a uniform therapy time of 1 to 60 minutes for all programs Use the arrow buttons to adjust time to desired setting Polarity cycle Option to adjust the polarity reversal time from 10 to 120 seconds Use the arrow buttons to adjust time to desired setting All manuals and user guides at all guides com ...

Page 24: ...elected using both arrow keys Note The device is preset with a default carrier frequency of 8000 Hz If you modify the carrier frequency in this menu the name of programs MF00 to MF04 and PM00 to PM06 will remain with 8000Hz The programs themselves will work with the frequency selected in this menu All manuals and user guides at all guides com ...

Page 25: ...ab 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 Note The threshold is adjusted using both arrow keys When coupling drops below the set percentage an acoustic signal sounds and therapy will pause The unit s default setting is 75 All manuals and user guides at all guides...

Page 26: ...onfigure 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 All manuals and user guides at all guides com a l l g u i d e s c o m ...

Page 27: ...pen 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 MedizinSystems technicians or technicians trained by Zimmer MedizinSystems only All manuals and user guides at all guides com ...

Page 28: ...me can result in a modification of the effects and the patient must be carefully monitored during treatment Starting the program Press the button to open the Program screen The program is selected here SonoStim program There are 3 different programmes available in SonoStim Electrotherapy Ultrasound therapy Combined therapy All manuals and user guides at all guides com ...

Page 29: ...erapy is selected by pressing on the appropriate row The following description refers to the electrotherapy program Selecting current forms group Select the current forms group by pressing on the appropriate row here Neuromuscular Electrical Stimulation NMES All manuals and user guides at all guides com ...

Page 30: ...ectrotherapy 7 Selecting current form Select the current form by pressing on the appropriate row here AB 00 Therapy screen After selecting the current form the therapy screen opens automatically for channel I All manuals and user guides at all guides com ...

Page 31: ...wn in the bar graph and the therapy 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 t...

Page 32: ...ltrasound therapy 7 Starting the program Press the button to open the Program screen The program is selected here Selecting ultrasound therapy Ultrasound therapy is selected by pressing on the appropriate row All manuals and user guides at all guides com ...

Page 33: ...erapy program by pressing on the appropriate row here US 01 Therapy screen After selecting the ultrasound therapy program 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 All manuals and user guides at all guides com ...

Page 34: ...apy 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 intensity setting is shown in the bar graph and the therapy time counts down in seconds The coupling display is active once the treatment is started All manuals and user guides at all guides com ...

Page 35: ...s 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 All manuals and user guides at all guides com ...

Page 36: ...oring 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 All manuals and user guides at all guides com a l l g u i d e s c o m ...

Page 37: ...f the next therapy treatment will be with a water bath Ending therapy in the water bath Press the button If the next therapy treatment will not be with a water bath 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 ultra...

Page 38: ...7 3 Combined therapy 7 Starting the program Press the button to open the Program screen The program is selected here Selecting Combined therapy Select Combined therapy by pressing on the appropriate row All manuals and user guides at all guides com ...

Page 39: ... Combined therapy 7 Selecting the program Select the desired Combined therapy program by pressing on the appropriate row Therapy screen After selecting the combined therapy program the therapy screen opens All manuals and user guides at all guides com ...

Page 40: ... 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 Combined therapy always ensure that the conducting electrode cable anode is only active on channel ...

Page 41: ...py 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 All manuals and user guides at all guides com a l l g u i d e s c o m ...

Page 42: ...am screen Selecting current forms group Select the current forms group by pressing on the appropriate row here Neuromuscular Electrical Stimulation NMES Note The additional steps required to carry out the therapy are described in more detail in Section 7 1 All manuals and user guides at all guides com ...

Page 43: ...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 Fast Path and Memory buttons are pressed Deactivate the message as described in Section 28 All manuals and user guides at all guides com ...

Page 44: ...tions are described in detail in Section 3 Start Press the button to open the start screen from the Programme window Fast Path Press the button to open Fast Path for editing to add the program to Fast Path in memory mode Programs Press the button to open the Programs window Indications Press the button to open the indications menu All manuals and user guides at all guides com ...

Page 45: ...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 forms run on channel 1 and channel 2 Note Twinstim and Duostim will use one user defined treatment timer ...

Page 46: ...procating activation The current forms are started and stopped simultaneously on both channels The surges are alternate Co contract activation The current forms are started and stopped simultaneously on both channels The surges are simultaneous Independent activation The current forms are started and stopped separately on both channels The surges are independent of one another Note Independent act...

Page 47: ...ighlighted in channel mode and can only be activated in Duostim mode Saving Press the button to open the screen to save a program 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 Fast Path screen to edit Fast Path All manuals and user guides at all guides co...

Page 48: ...nwards by one position Deleting Press the button when in the Edit screen to delete the highlighted program from the list Note You will be asked if you really want to delete the highlighted program Scrolling forwards Press the button to scroll one page down the list Scrolling backwards Press the button to scroll one page up the list All manuals and user guides at all guides com ...

Page 49: ...button to close the Fast Path and Memory programs 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 All manuals and user guides at all guides com ...

Page 50: ...ctrotherapy Screenshots of the various therapy screens 11 Monostim Example Program AB 00 on one channel I Twinstim Example Program AB 00 on both channels I and II All manuals and user guides at all guides com ...

Page 51: ...45 Electrotherapy Screenshots of the various therapy screens 11 Duostim reciprocating Duostim co contract Duostim independent All manuals and user guides at all guides com a l l g u i d e s c o m ...

Page 52: ...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 pause are changed the effects of the current form may also change The win...

Page 53: ...e total therapy time from the start of therapy After starting therapy the remaining time is displayed Bar graph of intensity Shows the currently specified intensity In CC mode display in mA eff or peak eff rms In CV mode display in V peak All manuals and user guides at all guides com ...

Page 54: ...y 1 2 Graphic view of waveform 1 3 Polarity 1 4 CC CV 1 5 Galvanic component Note Parameters 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 current intermediate freq...

Page 55: ...erses 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 All manuals and user guides at all guides com ...

Page 56: ...n Off Time 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 On Off Time deactivated When the On Off Time is deactivated the On Off Time window is shown in minimised form After activation of the On Off Time window the On Off Time can be activated an...

Page 57: ...n animation showing the On Off Time position Synchronisation mode reciprocating Reciprocating In two channel mode the alternating reciprocating On Off Time mode is shown by the two opposing arrows in the top left corner Synchronisation mode Co contract Co contract In two channel mode the co contract On Off Time mode is shown by the two parallel arrows in the top left corner All manuals and user gu...

Page 58: ... 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 are shown in blue and th...

Page 59: ...ith 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 All manuals and user guides at all guides com ...

Page 60: ...e 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 All manuals and user guides at all guides com ...

Page 61: ...Change current form parameters 12 Saving parameters Press the button to save the modified parameters Cancelling changes Press the button to reject changes All manuals and user guides at all guides com a l l g u i d e s c o m ...

Page 62: ... Time button When the On Off Time button is activated the On Off Time Parameters window is opened On Off Time parameters The On Off Time 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 On Time 0 s Longest On Time 60 s Shortest fall time 0 2 s Longest fall time 5 s Shortest Off Time 0 2 s Longest Off Time 60 s ...

Page 63: ...meters Select the parameters to be changed using the arrow keys 1 Rise time 1 5 s here 2 On Time 4 0 s here 3 Off 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 On Off Time parameters definition All manuals and user guides at all guides com ...

Page 64: ...therapy 12 5 Change On Off Time parameters 12 Saving parameters Press the button to save the modified parameters Cancelling changes Press the button to reject changes All manuals and user guides at all guides com ...

Page 65: ...vated 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 shown simultaneously fo...

Page 66: ...60 Ultrasound therapy Screenshot of the therapy screen 13 All manuals and user guides at all guides com a l l g u i d e s c o m ...

Page 67: ... 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 program 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 duty cycle All manuals and use...

Page 68: ...e Duty Cycle 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 20 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 All manuals and user guides at all guides com ...

Page 69: ...eneficial 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 current specified intensity All manuals and user guides at all guides com ...

Page 70: ... 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 All manuals and user guides at all guides ...

Page 71: ...s of 1 2 1 3 1 5 and 1 10 Note The duty cycle of 1 10 only provides comfort heating 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 All manuals and user guides at all guides com a l l g u i d e s c o m ...

Page 72: ...d therapy 14 2 Description of the parameter button 14 Saving Press the button to save the modified parameters Cancelling changes Press the button to reject changes made All manuals and user guides at all guides com ...

Page 73: ...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 Frequency button to open the Frequency screen Adjust the frequency ratios 0 8 MHz to 2 4 MHz using both arrow keys All manuals and user guides at all guides com ...

Page 74: ...functions on the Combined therapy screen correspond exactly to the therapy screens for Electrotherapy and Ultrasound therapy as described in the previous sections An extensive description of the therapy screen will not be given here All manuals and user guides at all guides com ...

Page 75: ...e 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 All manuals and user guides at all guides com ...

Page 76: ...body region shoulder in this example the Indication window opens showing various indications in the shoulder region Select the indication by clicking on the relevant row Pain Management Acute in this example All manuals and user guides at all guides com a l l g u i d e s c o m ...

Page 77: ...lecting the detailed indications another window opens showing detailed therapy information and a suggested program Selecting the therapy program Press the button to open the therapy screen with the programme All manuals and user guides at all guides com ...

Page 78: ...eparately modified and saved Note The procedure for saving is similar for all therapy forms The save procedure for an electrotherapy program is described below Selecting the program Changing the parameters The change is shown in the title bar AB 00 modified All manuals and user guides at all guides com ...

Page 79: ...rogram Two options are available for naming a program 1 Accept the program name in the input field 2 Enter a custom program name If using a custom name use the keyboard to enter the program name Note When entering a custom program name the name in the input field must first be deleted All manuals and user guides at all guides com ...

Page 80: ...h Press the button to open Fast Path Adding the program to Fast Path Press the button to add the program to Fast Path The program is automatically saved in the first free space in the list F Fast Path 00 Program number in the list All manuals and user guides at all guides com ...

Page 81: ...utton to open the Memory Adding the program to the Memory Press the button to add the program to the Memory The program is automatically saved in the first free space in the list S Memory 00 Program number in the list All manuals and user guides at all guides com a l l g u i d e s c o m ...

Page 82: ...rogrammes are listed in Fast Path From here they can be 1 retrieved for therapy or 2 edited sequence changed or deleted Selecting Fast Path Press the button to open Fast Path Selecting therapy Select the desired program by pressing on the appropriate row All manuals and user guides at all guides com ...

Page 83: ...th Press the button to open the Edit Fast Path screen Selecting the program Select the program to be edited by clicking on the appropriate row Changing sequence Activate the appropriate arrow keys to move the program up or down in the sequence All manuals and user guides at all guides com ...

Page 84: ...emory 18 2 Editing Fast Path 18 Deleting a program Pressing the button triggers the security question Delete Press the button to delete the saved program Press the button to keep the saved program All manuals and user guides at all guides com ...

Page 85: ...utton to open the Memory Selecting therapy Select the desired program by pressing on the appropriate row Editing Memory Note The following steps to edit the Memory correspond exactly to those used to edit Fast Path that were described in detail in the preceding section All manuals and user guides at all guides com ...

Page 86: ...ating 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 All manuals and user guides at all guides com a l l g u i d e s c o m ...

Page 87: ...ons 12 7 in x 9 2 in x 5 1 in 322 mm x 234 mm x 130 mm Weight 4 6 lbs 2 1 kg Transport in original packaging only Operational environment 50 F to 104 F 10 C to 40 C 30 to 75 rel humidity 700 1060 hPa Storage 50 F to 122 F 10 C to 50 C 10 to 90 rel humidity 700 1060 hPa Regulatory Compliance IEC EN 60601 1 IEC EN 60601 1 2 IEC EN 60601 2 5 IEC EN 60601 2 10 All manuals and user guides at all guides...

Page 88: ... or alternating Biphasic rectangular symmetric Amplitude Phase duration Pause Frequency Burst Frequency 0 100mA 100µs 1ms 0 5ms 10s 0 1667Hz 1 200Hz Middle Frequency Amplitude Carrier Frequency 0 100mA 2000 8000Hz Premodulated Amplitude Carrier Frequency Beat Frequency Sweep low frequency Sweep high frequency 0 100mA 2000 8000Hz 1 200Hz 1 100Hz 10 200Hz Interferential Amplitude Carrier Frequency B...

Page 89: ...Hz Maximum output 6 9 W at 0 8 MHz 800 kMHz 7 1 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 factor 1 1 1 2 1 3 1 5 1 10 Note Duty cy...

Page 90: ... 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 Sponge holders Rinse sponge holders well with water after every treatment Disinfect by washing at 95 C or sterilising in an autoclave Do not use cleaning agents containing alco...

Page 91: ... water is most suitable To attach the sponge pockets use the rubber bands The electrodes need to cling to the body surface with a slight pressure however pressure marks should not be left by the rubber bands Electrically plate electrodes are connected like disposable electrodes using the electrode lead clips The clips are connected to the plate electrodes which have been previously placed inside t...

Page 92: ...ith a moist sponge Note The disposable electrode is intended for single use only and can be disposed of in household waste Re use of disposable electrodes may result in a hazard for the patient Rubber electrodes Rubber electrodes are suitable for therapy with bipolar currents when used for purely galvanic current currents with galvanic components or long pulse durations it must be noted that the n...

Page 93: ...0320 Storage tray right 65910310 Storage tray left 65920310 Test resistance Electrotherapy 154 2 electrode cables incl 2 red and 2 black alligator clips 2 90 m long incl magnetic clip 68910111 1 pair electrode cables 2 90 m 31100146 Alligator clip red 31100147 Alligator clip black 16 Disposable electrodes 135 pairs small 1 package 17 Disposable electrodes 90 pairs medium 1 package 18 Disposable el...

Page 94: ... No 154 2 electrode cables incl 2 red and 2 black alligator clips 2 90 m long incl magnetic clip 68910111 1 pair electrode cables 2 90 m 31100146 Alligator clip red 31100147 Alligator clip black 16 Disposable electrodes 135 pairs small 1 package 17 Disposable electrodes 90 pairs medium 1 package 18 Disposable electrodes 45 pairs large 1 package 25 Disposable electrodes 50 pairs round 1 package 658...

Page 95: ... only by persons authorised by Zimmer MedizinSystems 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 trained personnel only disconnect the device from the power sup...

Page 96: ...operational reliability of the device Stimulation current Select program DC 00 Insert test adapter test Patient The display in the bar 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 co...

Page 97: ...ng and operating the therapy devices Soleo SonoStim and Soleo Stim 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 All manuals and user guides at all guides com ...

Page 98: ...t 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 again contact customer ...

Page 99: ...e device off waiting five seconds and switching it on again If this does not work contact customer service Customer service can be contacted through the head office in Irvine CA The device must be sent to the factory in the original packaging only Head office Zimmer MedizinSystems 25 Mauchly Suite 300 Irvine CA 92618 www zimmerusa com Disposal The device must be disposed of by an approved disposal...

Page 100: ...ed below The customer or the user of the Soleo SonoStim Soleo Stim 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 Stim device must emit electromagnetic energy in order to perform its intended function Nearby electronic equipment may be affected RF emissions CI...

Page 101: ...V 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 dip in UT for 0 5 cycle 40 UT 60 d...

Page 102: ...communications equipment should be used no closer to any part of Soleo SonoStim Soleo Stim 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...

Page 103: ... are controlled The customer or user of the Soleo SonoStim Soleo Stim device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF telecommunications equipment transmitters and the Soleo SonoStim Soleo Stim device as recommended below according to the maximum output power of the communications equipment Rated maximum output power of transmit...

Page 104: ...tions reserved Soleoline User Manual Zimmer MedizinSystems 25 Mauchly Suite 300 Irvine CA 92618 800 327 3576 949 727 2154 fax www zimmerusa com info zimmerusa com User Manual Soleo SonoStim Soleo Stim All manuals and user guides at all guides com ...

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