Zimmer Soleo Stim User Manual Download Page 97

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Technical safety checks

National laws and regulations must be observed when installing 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.

Summary of Contents for Soleo Stim

Page 1: ...User Manual Soleoline Soleo SonoStim Soleo Stim User Manual Soleo SonoStim Soleo Stim USA...

Page 2: ...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...

Page 3: ...or 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...

Page 4: ...5 3 Warnings 3 1 General 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...

Page 5: ...Description of screen 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 6...

Page 6: ...94 Valid for Soleo SonoStim Soleo 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 ope...

Page 7: ...Post traumatic acute pain Post surgical acute pain Indications for Medium Frequency Monophasic Currents Biphasic Symmetric Currents and High Voltage Relaxation of muscle spasm Increasing local blood c...

Page 8: ...muscle spasms and joint 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...

Page 9: ...d their definitions before 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 pote...

Page 10: ...ology is established or 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 irrita...

Page 11: ...over or near bone growth centers until 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 ca...

Page 12: ...g only to a grounded electrical service receptacle conforming to the applicable national and local electrical codes Before administering any treatment to a patient you should become acquainted with th...

Page 13: ...est may increase the risk 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 ele...

Page 14: ...ns Operation of the ultrasound 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 ma...

Page 15: ...What are the advantages 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...

Page 16: ...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 Whe...

Page 17: ...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 t...

Page 18: ...ive 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...

Page 19: ...urations The options are 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...

Page 20: ...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 buttons to open the window to adjust the volume The vo...

Page 21: ...tons to set the time until the screen saver is enabled Note While therapy is running the screen saver function is disabled Welcome message Option to configure an individual welcome message Activate th...

Page 22: ...ral 6 Setting defaults 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 b...

Page 23: ...e settings required for 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 Polarit...

Page 24: ...Hz The frequency is selected 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...

Page 25: ...y settings Press the tab 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...

Page 26: ...asound therapy 6 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 pressi...

Page 27: ...sert 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 plan...

Page 28: ...hanging the therapy time 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 p...

Page 29: ...ectrotherapy Electrotherapy 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 b...

Page 30: ...ng instructions 7 1 Electrotherapy 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 ope...

Page 31: ...left The effective current is shown 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...

Page 32: ...ing instructions 7 2 Ultrasound 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 p...

Page 33: ...desired ultrasound therapy 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...

Page 34: ...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 int...

Page 35: ...es 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 botto...

Page 36: ...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 pr...

Page 37: ...ath Press the button If 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 the...

Page 38: ...perating instructions 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 pressin...

Page 39: ...ating instructions 7 3 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 progr...

Page 40: ...r 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 d...

Page 41: ...ic 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 dis...

Page 42: ...tton to open the Program 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...

Page 43: ...ined 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 Fast Path and Memory buttons are pressed D...

Page 44: ...e settings menu The options 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 a...

Page 45: ...tions 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...

Page 46: ...he Twinstim and Duostim modes Reciprocating activation The current forms are started and stopped simultaneously on both channels The surges are alternate Co contract activation The current forms are s...

Page 47: ...ote 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 program The Save button can only be pressed from the the...

Page 48: ...order of the list downwards 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 h...

Page 49: ...ns 10 Close Press the 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 change...

Page 50: ...44 Electrotherapy 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...

Page 51: ...45 Electrotherapy Screenshots of the various therapy screens 11 Duostim reciprocating Duostim co contract Duostim independent...

Page 52: ...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 t...

Page 53: ...Therapy time Shows the 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 di...

Page 54: ...4 1 1 Frequency display 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...

Page 55: ...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...

Page 56: ...ion see Section 10 5 Note If the On 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...

Page 57: ...Off Time is shown as an 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 t...

Page 58: ...o 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...

Page 59: ...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...

Page 60: ...ent 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 p...

Page 61: ...55 Electrotherapy 12 4 Change current form parameters 12 Saving parameters Press the button to save the modified parameters Cancelling changes Press the button to reject changes...

Page 62: ...alue Activating On Off 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...

Page 63: ...wn time Selecting parameters 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...

Page 64: ...58 Electrotherapy 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...

Page 65: ...ameters 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 modulatio...

Page 66: ...60 Ultrasound therapy Screenshot of the therapy screen 13...

Page 67: ...rmation 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...

Page 68: ...here 1 2 Operating mode 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 Dep...

Page 69: ...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 coupl...

Page 70: ...o 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 act...

Page 71: ...continuous pulsed with duty cycles 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 frequenc...

Page 72: ...66 Ultrasound 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...

Page 73: ...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 Frequency button to op...

Page 74: ...Note The buttons and 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 de...

Page 75: ...Indications menu 16 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 circ...

Page 76: ...ation After selecting the desired 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...

Page 77: ...y information After selecting the detailed indications another window opens showing detailed therapy information and a suggested program Selecting the therapy program Press the button to open the ther...

Page 78: ...am parameters can be separately 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 prog...

Page 79: ...gram name Naming the program 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...

Page 80: ...a program in Fast Path 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 i...

Page 81: ...program in the Memory Press the button 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...

Page 82: ...The individual saved programmes 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 Sel...

Page 83: ...ath 18 Editing Fast Path 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 appr...

Page 84: ...diting Fast Path and memory 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...

Page 85: ...ing Memory Press the button 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 exa...

Page 86: ...tructions 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 I...

Page 87: ...d part Type BF Dimensions 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...

Page 88: ...00Hz Positive negative or alternating Biphasic rectangular symmetric Amplitude Phase duration Pause Frequency Burst Frequency 0 100mA 100 s 1ms 0 5ms 10s 0 1667Hz 1 200Hz Middle Frequency Amplitude Ca...

Page 89: ...0 kMHz 2 4 cm at 2 4 MHz 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 valu...

Page 90: ...stic 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 a...

Page 91: ...es during the therapy Lukewarm tap 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 mar...

Page 92: ...ld also be cushioned with 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...

Page 93: ...250130 Mains cable 65910320 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 magneti...

Page 94: ...ances Accessories Item 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 Alli...

Page 95: ...ations are implemented 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 ult...

Page 96: ...r if there is any doubt about the 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 a...

Page 97: ...observed when installing 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 t...

Page 98: ...als 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 fau...

Page 99: ...red after switching the 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...

Page 100: ...c environments specified 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...

Page 101: ...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 volta...

Page 102: ...ortable and mobile RF 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...

Page 103: ...diated RF disturbances 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...

Page 104: ...I Version 2 I Modifications 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 Sol...

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