User Manual Soleoline

Transcription

1 User Manual Soleoline Soleo SonoStim, Soleo Stim USA

2 Soleo SonoStim / Soleo Stim Front view of device Fig Selection and control elements 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 Screen readouts 8 Status bar 10 Title bar 9 Navigation bar 11 Buttons on the screen

3 Soleo SonoStim / Soleo Stim Rear view of device Fig 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 Soleoline

4 Contents Soleo SonoStim / Soleo Stim Front view of device Selection and control elements/screen readouts Rear view of device Switch and connector sockets Page 1. Indications 1.1 Electrotherapy Ultrasound therapy 2 2. Contraindications, Cautions Electrotherapy Ultrasound therapy 5 3. Warnings 3.1 General Electrotherapy Ultrasound therapy 8 4. Soleoline Summary 9 5. Fitting the cables, starting the system 5.1 Soleo SonoStim / Soleo Stim Configuration 6.1 General Electrotherapy Ultrasound therapy Maintenance Soleo SonoStim Quick operating instructions 7.1 Electrotherapy Ultrasound therapy Water bath treatment Combined therapy Soleo Stim Quick operating instructions General information SD card 37

5 Contents Page 10. Description of the selection buttons Electrotherapy Screenshots of the various therapy screens Electrotherapy 12.1 Description of the screen elements Description of the parameter button Description of the On/Off time button Change current form parameters Change On/Off time parameters Description of the screen elements and the interference button Ultrasound therapy Screenshot of the therapy screen Ultrasound therapy 14.1 Description of screen elements Description of the parameter button Description of the Frequency button Combined therapy Screenshot of the therapy screen Indications menu Saving a modified programme Fast Path Memory Retrieving and editing fast path and memory 18.1 Retrieving fast path Editing fast path Retrieving and editing memory Explanation of symbols General technical information Soleo SonoStim / Soleo Stim Specific technical Information 21.1 Stimulation current Ultrasound Cleaning, Disinfection Electrodes 23.1 Use and care Information about the use of various electrode types 86

6 Contents Page 24. Contents on delivery, Accessories 24.1 Soleo SonoStim Soleo Stim Safety and maintenance Functional test Technical safety checks Error messages, Troubleshooting, Disposal Manufacturer's EMC declaration 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 operate this device. These Operating Instructions are valid from 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 the use of the device.

7 Indications Electrotherapy Indications for use Indications for Pain Management IFC, Premodulated, Microcurrent, Biphasic Currents Symptomatic relief or management of chronic, intractable pain 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 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 1

8 Indications Ultrasound therapy Indications for use Relief of pain, muscle spasms and joint contractures Relief of pain, 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 and scar tissues Relief of pain, muscle spasms and joint contractures resulting from: o Capsular tightness o Capsular scarring 2

9 Contraindications, Cautions 2 Precautionary Definitions Caution The precautionary instructions found in the section 2 and 3 and throughout the manual are indicated by specific symbols. Understand these symbols and their definitions before operating this equipment. The definition of these symbols are as follows: 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. 3

10 Contraindications, Cautions Electrotherapy Contraindications Powered muscle stimulators should not be used on patients with cardial demand pacemakers. Other contraindications are patients suspected of carrying serious infectious disease and or disease where it is advisable, for general medical purposes, to suppress heat or fevers. Caution should be used for patients with suspected or diagnosed heart problems. Caution should be used for patients with suspected or diagnosed epilepsy. Caution should be used in the presence of the following: o When there is a tendency to hemorrhage following acute trauma or fracture; o Following recent surgical procedures when muscle contraction may disrupt the healing process; o Over the menstruating or pregnant uterus; and Over areas of the skin which lack normal sensation. This device should not be used for symptomatic local pain relief unless etiology 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 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 and stimulation settings should be based on the guidance of the prescribing practitioner. Powered muscle stimulators should be kept out of the reach of children. Powered muscles stimulators should be used only with the leads and electrodes recommended for use by the manufacturer. The effectiveness of TENS waveforms is highly dependent upon patient selection by a person qualified in pain management. Inspect patient cables and associated connectors before each use Adverse Effects Skin irritation and burns beneath the electrodes have been reported with the use of powered muscle stimulators. Potential adverse effects with TENS are skin irritation and electrode burns. 4

11 Contraindications, Cautions Ultrasound therapy Contraindications This device should not be used on any patient with obtuned reflexes or any area that has significant diminished pain sensitivity or heat sensitivity. This device should not be used for symptomatic local pain relief unless etiology is established or unless pain syndrome has been diagnosed. This device should not be used over or in a region of tumor/malignancy. This device should not be used when open wounds are present in the treatment area. This device should not be used directly over the portion of the spinal cord that is no longer protected by bone following a laminectomy. This device should not be used on patients suspected of carrying serious infectious disease and or disease where it is advisable, for general medical purposes, to suppress heat or fevers. This device should not be used 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 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 potential pregnant patient. This device should not be used on ischemic tissues in individuals with vascular disease where the blood supply would be unable to follow the increase in metabolic demand and tissue necrosis might result. Metal implants and endoprostheses There are no longer any concerns about dynamic ultrasound application in low doses. Cautions Before each use, inspect the ultrasound heads for cracks, which may allow the ingress of conductive fluid Over an area of the spinal cord following: o Laminectomy, i.e., when major covering tissues have been removed o Over anesthetic areas o On patients with hemorrhagic diatheses 5

12 Warnings General Please note: Never connect two patients to the device in one session! 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 the use of the device. Do not use the device in wet rooms (hydrotherapy) or balneotherapy rooms. Do not leave patients unattended during treatment. This device is exclusively for use by qualified medical personnel. This device may cause malfunctioning in or may interfere with the operation of devices in its vicinity. It may be necessary to take action to avoid interference such as using a different alignment, moving the device or shielding it. Make certain that the unit is grounded by connecting 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 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 electrotherapy and ultrasound therapy. To prevent electrical shock, disconnect the unit from the power source before attempting any maintenance or cleaning procedure Handle the ultrasound head carefully as rough treatment may alter its properties. Do not bring the ultrasound head into contact with sharp or pointed objects as the aluminium head is easily scratched. Handle, clean and dispose of components and accessories that have come in contact with body fluids according to national, local and facility rules, regulations and procedures 6

13 Warnings Electrotherapy Electrotherapy Do not conduct electrotherapy treatment on patients with implants or any other implanted electronic device unless the risk has been assessed and found negligible. Patients must not be connected to a radio-frequency surgical device at the same time. This may cause burns under the electrotherapy electrodes. Operation of the electrotherapy device in the vicinity (e.g., within 1 m) of strong electromagnetic fields (e.g., tomographs, X-ray or diathermy 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/cm² electrode surface. If the current density exceeds 2 ma eff/cm², users must be extremely vigilant during treatment. Positioning the electrodes in the vicinity of the chest 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 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 or mouth. Severe spasm of the laryngeal and pharyngeal muscles may occur and the contractions may be strong enough to close the airways or cause difficulty in breathing. Stimulation should not be applied transthoracically in that the introduction of electrical current into the heart may cause cardiac arrhythmias. Stimulation should not be applied transcerebrally. Stimulation should not be applied over swollen, infected, or inflamed areas or skin eruptions, e.g., phlebitis, Thrombophlebitis, varicose veins, etc. Stimulation should not be applied over, or in proximity to, cancerous lesions. If the intensity control is increased, there may be currents greater than 10 ma eff and voltages greater than 10 V may apply at the outlet sockets. 7

14 Warnings Ultrasound therapy Ultrasound therapy Caution: Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous exposure to ultrasonic energy. Do not conduct ultrasound therapy on patients with implants or any other implanted electronic device unless the risk has been assessed and found to be negligible. Patients must not be connected to a radio-frequency surgical device at the same time. This may result in burns. 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 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 easily scratched. Disinfect the ultrasound head with standard disinfectants after use. Use a coupling agent which is intended for ultrasound treatment and has high electrical conductivity. Use a coupling agent which is a cleared medical device on the US market. 8

15 Soleoline Summary 4 What is Soleoline? An ultramodern and innovative range of products with 3 different devices available. Soleo SonoStim An ultramodern and innovative combination device for electrotherapy and ultrasound therapy. Soleo Stim An ultramodern and innovative electrotherapy device. Soleo Sono An ultramodern and innovative ultrasound therapy device. Note: What does the Soleoline do? What are the advantages of Soleoline? The operation of Soleo Sono is described in a separate set of instructions. Output of monophasic, biphasic and medium frequency currents for nerve stimulation and muscle therapy for mono channel and dual channel operation as well as output of therapeutic ultrasound. 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 compact design saves room in the practice and is highly suited for use in home visits. Innovations in Soleoline? Note: SonoSwing, the innovation in the field of ultrasound therapy: a single ultrasound head with two frequencies 0,8MHz and 2,4 MHz freely selectable penetration depths using percentage adjustment of the frequency ratios. The device should only be used by medical specialists (e.g. doctors, therapists and health paraprofessionals). 9

16 Fitting the cables Starting the system Soleo SonoStim / Soleo Stim Note: Note: Electrotherapy The following description of fitting the cables refers to the operation of Soleo SonoStim / Soleo Stim. There are green arrows on the cables as guides for correct connection with the device. When connecting the electrode cable ensure that the green arrow is pointing downwards when being plugged in. Plug the electrode cable for channel I into the appropriate socket (18). Plug the electrode cable for channel 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 socket (17). Connecting the mains cable Switching on the device Note: Plug the mains cable into the appropriate socket (12) on the device and then plug into the mains socket. Switch on the device using the rocker switch (14). All buttons, menus and submenus are activated directly on the screen by touching it or using the touch pen. 10

17 Configuration General Note: Note: Start screen The following descriptions always refer to therapy using a single channel and are based on the factory default settings. Changes to the default settings can only be made from the start screen. After switching on the device and the self-test, the start screen opens. Selecting configuration Press the button to open the configuration menu. 11

18 Configuration General Configuration menu In the configuration menu the factory settings can be changed and individually set. After activation of the configuration menu the Select configuration screen is active. 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 drop-down menu to select the language. arrow key to open the The language is selected by pressing on the appropriate row. 12

19 Configuration General Start settings Configuration options for the program start settings: Press the arrow key to open the drop-down menu to select the program start configurations. The options are selected by pressing on the appropriate row. Note: Start display This section will determine what screen the unit defaults to when Start is pressed from the Start Display screen. Option to choose between 2 start display screens: Press the drop-down menu to select the start screen. arrow key to open the The selection is made by pressing on the appropriate row. 13

20 Configuration General Sound To switch the signal sound on and off when activating the control fields: arrow key to open the drop- Press the down menu to switch 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 open the window to adjust the volume. arrow buttons to 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. 14

21 Configuration General Screen saver Option to configure the start of the screen saver after 0 to 20 minutes: Press the arrow buttons to set the time until the screen saver is enabled. Note: Welcome message While therapy is running the screen saver function is disabled. 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. 15

22 Configuration General 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 button to close the window. 16

23 Configuration Electrotherapy Electrotherapy settings Activate the menu to open the Electrotherapy configuration 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 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. 17

24 Configuration Electrotherapy Frequency Option to adjust the default carrier frequency to 2500 Hz, 4000 Hz or 8000 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 MF04 and PM00 to PM06 will remain with 8000Hz. The programs themselves will work with the frequency selected in this menu. 18

25 Configuration Ultrasound therapy Note: Ultrasound therapy settings Activation of the Ultrasound Therapy menu and the associated settings is only possible in the Soleo SonoStim version. 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: 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%. 19

26 Configuration Ultrasound therapy 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. 20

27 Configuration Maintenance Updates Press the tab to open the Maintenance screen. The maintenance programs are protected by passwords. Use the keyboard to insert the password. To open the update menu, enter the password armin. Software can be updated using the updates menu. You will receive the latest information about updating software when an update is planned. For servicing other passwords are necessary. Servicing is permissible by Zimmer MedizinSystems technicians or technicians trained by Zimmer MedizinSystems only. 21

28 Soleo SonoStim Quick operating instructions Electrotherapy Note: The following note applies to all therapy forms available in the system. Changing 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 selected here. button to open the Program screen. The program is SonoStim program There are 3 different programmes available in SonoStim. - Electrotherapy - Ultrasound therapy - Combined therapy 22

29 Soleo SonoStim Quick operating instructions Electrotherapy Selecting electrotherapy 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 by pressing on the appropriate row (here Neuromuscular Electrical Stimulation (NMES)). 23

30 Soleo SonoStim Quick operating instructions Electrotherapy 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. 24

31 Soleo SonoStim Quick operating instructions Electrotherapy Starting therapy The display in the lower status bar changes from Ready to Active and the therapy is started by adjusting the intensity using the intensity controller on the 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, 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. 25

32 Soleo SonoStim Quick operating instructions Ultrasound therapy Starting the program Press the selected here. button to open the Program screen. The program is Selecting ultrasound therapy Ultrasound therapy is selected by pressing on the appropriate row. 26

33 Soleo SonoStim Quick operating instructions Ultrasound therapy Selecting the program Select the 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 shown on the Parameter button (here 5 cm 2 ) matches the ultrasound head connected before starting therapy. 27

34 Soleo SonoStim Quick operating instructions Ultrasound therapy Setting intensity Adjust the intensity using the intensity 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 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. 28

35 Soleo SonoStim Quick operating instructions Ultrasound therapy Ending therapy At the end of the therapy time an acoustic 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 and the Stop button changes to Start at the end of the therapy. 29

36 Soleo SonoStim Quick operating instructions Water bath treatment Note: Implementation If the ultrasound therapy is done in a water bath, the ultrasound head temperature monitoring must be changed before starting the therapy. 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. 30

37 Soleo SonoStim Quick operating instructions Water bath treatment If at the end of the therapy an additional treatment with the same ultrasound program will be carried out, after adjusting the intensity, the following message appears: If, at the end of therapy, the program will be changed, the function of the water bath button is automatically deactivated. Continuing therapy in the water bath 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 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 this is happening. Once the temperature adjustment of the ultrasound head is complete, the message disappears and the therapy can be continued. 31

38 Soleo SonoStim Quick operating instructions Combined therapy Starting the program Press the selected here. button to open the Program screen. The program is Selecting Combined therapy Select Combined therapy by pressing on the appropriate row. 32

39 Soleo SonoStim Quick operating instructions Combined therapy 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. 33

40 Soleo SonoStim Quick operating instructions Combined therapy Setting intensity of the ultrasound Adjust the intensity using the intensity controller on the left. Starting therapy Combined therapy is activated by adjusting the intensity using the intensity controller 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 Combined therapy, always ensure that the conducting electrode cable (anode) is only active on channel I. The second electrode is then the ultrasound head. 34

41 Soleo SonoStim Quick operating instructions Combined therapy Ending therapy At the end of the therapy time, an acoustic 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. 35

42 Soleo Stim Quick operating instructions 8 Starting the program Press the button 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 required to carry out the therapy are described in more detail in Section

43 General information 9 SD card SD card Note: User-defined settings and the indications list are saved on the SD card. 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

44 Description of the selection buttons 10 Note: Configuration The following descriptions are all based on the factory settings. Press 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. 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. 38

45 Description of the selection buttons 10 Memory Press the button to open the memory list for editing to add the program to the memory list in memory mode. Channel Press the button 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 forms run on channel 1 and channel 2. Note: Twinstim and Duostim will use one user-defined treatment timer with independent intensity settings. 39

46 Description of the selection buttons 10 Channel Group In Monostim mode, channel 1 or channel 2 can be activated for the desired therapy. Activates channel I, channel I is active. Activates channel II, channel II is active. Synchronisation group The surge output is defined here for the 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 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 activation can only be activated in Duostim mode. 40

47 Description of the selection buttons 10 Press the button to select a different current form for channel I. Press the button to select a different current form for channel II. Note: Saving Both buttons are highlighted in channel mode and can only be activated in Duostim mode. 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 41

48 Description of the selection buttons 10 Moving Press the button to move the order of the list upwards by one position. Moving Press the button to move the order of the list downwards by one position. Deleting Press the button when in the Edit screen to delete the highlighted program from the list. Note: Scrolling forwards You will be asked if you really want to delete the highlighted program. Press the button to scroll one page down the list. Scrolling backwards Press the button to scroll one page up the list. 42

49 Description of the selection buttons 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 changes are applied by pressing the button. 43

50 Electrotherapy 11 Screenshots of the various therapy screens Monostim Example: Program AB 00 on one channel (I). Twinstim Example: Program AB 00 on both channels (I and II). 44

51 Electrotherapy 11 Screenshots of the various therapy screens Duostim reciprocating Duostim co-contract Duostim independent 45

52 Electrotherapy Description of the screen elements Note: The Parameter and On/Off Time buttons turn into control panels once an electrotherapy program has been selected. Title bar The title bar shows the channel mode and the name of the effective current form. Status bar The status bar shows information on the current status of the therapy. If the therapy is not active, it shows the word Ready. During therapy, it shows the word Active. 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 window is therefore no longer visible after a change. 46

53 Electrotherapy Description of the screen elements Therapy time Shows the total therapy time from the start of therapy. After starting therapy the remaining time is displayed. Bar graph of intensity In CC mode: display in ma eff or peak. (eff = rms) Shows the currently specified intensity. In CV mode: display in V peak. 47

54 Electrotherapy Description of the parameters button Parameters 1. Presents the parameters of the current therapy program. 2. Activates Parameters of Current Form for modification. A detailed description can be found in Section Frequency display 1.2 Graphic view of waveform 1.3 Polarity 1.4 CC / CV 1.5 Galvanic component Note: Parameters 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 frequency as a bar. 48

55 Electrotherapy Description of the parameters button 1.2 Waveform Graphic view of waveform. 1.3 Polarity Display of polarity: only positive only 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% 49

56 Electrotherapy Description of the On/Off Time button On/Off Time active Indicates that a On/Off Time is activated and shows the parameters of the effective On/Off Time. 6.0 / 12.0 s rise time and retention time of the On/Off Time phase in seconds pause of the On/Off Time phase in seconds After activation of the On/Off Time window, the On/Off Time parameters can be set separately. For a detailed description see Section 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 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 and the On/Off Time parameters can be set separately. For a detailed description see Section Note: If there is no factory setting for a On/Off Time in a program, this window is not shown. 50

57 Electrotherapy Description of the On/Off Time button On/Off Time inactive When the therapy is inactive, the On/Off Time is shown completely in blue. On/Off Time active During therapy, the On/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 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. 51

58 Electrotherapy Change current form parameters Note: Note: Only the parameters that are shown in the parameter window can be changed. If the Parameters button is activated during therapy, the therapy will be interrupted, the intensity returns to zero and the therapy time is set to the standard value. 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 the fixed parameters are grey. 52

59 Electrotherapy Change current form parameters Selecting the parameters The parameters that are to be changed are selected with the arrow keys. The parameter highlighted in blue can be changed (impulse time here). Note: Changing parameters Changes to the pulse and pulse hold time also change the frequency. Use the arrow keys to increase or decrease the value within the limits specified in the current form definition. 53

60 Electrotherapy Change current form parameters Galvanic component Press the arrow keys to reinforce the current form with a galvanic component 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). 54

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

62 Electrotherapy Change On/Off Time parameters Note: Activating On/Off-Time button If the On/Off Time button is activated during therapy, the therapy will be interrupted, the intensity returns to zero and the therapy time is set to the standard value. 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: Shortest rise time: Longest rise time: Shortest On-Time: Longest On-Time: Shortest fall time: Longest fall time: Shortest Off-Time: Longest Off-Time: 0 s: surge off 0.5 s 60 s 0 s 60 s 0.2 s 5 s 0.2 s 60 s 56

63 Electrotherapy Change On/Off Time parameters The duration of the On/Off-Time phase is calculated from the duration of the rise time, On-Time and down 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 (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. 57

64 Electrotherapy Change On/Off Time parameters Saving parameters Press the button to save the modified parameters. Cancelling changes Press the button to reject changes. 58

65 Electrotherapy Description of the screen elements and the interference button Interference parameter window This parameter window shows the maximum effect. Static with sweep deactivated. Animated with sweep activated. Animated view Static view When the parameters 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 shown simultaneously for both circuits by the left-hand adjuster. 59

66 Ultrasound therapy 13 Screenshot of the therapy screen 60

67 Ultrasound therapy Description of the screen elements Title bar The title bar shows the channel mode and the name of the current ultrasound therapy program. Status bar The status bar shows information on the current status of the therapy. If the therapy is not active, it shows the word Ready. During therapy, it shows the word Active. Parameters 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 Ultrasound head and size of ultrasound head 1.2 Operating mode / pulse frequency / duty cycle 61

68 Ultrasound therapy Description of the screen elements 1.1 Ultrasound head Graphic view of the active ultrasound head (large ultrasound head 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). 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) 62

69 Ultrasound therapy Description of the screen elements Coupling The coupling is shown digitally as a percentage. Important: The most beneficial coupling value is 100%. If the coupling is below the preset value (factory setting 75%), an acoustic signal sounds and the therapy time is paused. 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. 63

70 Ultrasound therapy Description of the parameter button Note: Note: Activating the parameter button If the Parameters button is activated during therapy, the therapy will be interrupted, the intensity returns to zero and the therapy time is set to the standard value. Only the parameters that are shown in the parameter window can be changed. 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. 64

71 Ultrasound therapy Description of the parameter button Selecting the mode Press the two arrow buttons to select the desired mode. Modes: continuous pulsed with duty cycles of 1:2, 1:3, 1:5 and 1:10 Note: Selecting the frequency The duty cycle of 1:10 only provides comfort heating. 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. 65

72 Ultrasound therapy Description of the parameter button Saving Press the button to save the modified parameters. Cancelling changes Press the button to reject changes made. 66

73 Ultrasound therapy Description of the frequency button Note: Adjusting treatment depth If the Frequency button is activated during therapy, the therapy will be interrupted, the intensity returns to zero and the therapy time is set to the standard value. Press the Frequency button to open the Frequency screen. Adjust the frequency ratios 0.8 MHz to 2.4 MHz using both arrow keys. 67

74 Combined therapy 15 Screenshot of the therapy screen 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 description of the therapy screen will not be given here. 68

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 circle. 69

76 Indications menu 16 Selecting by indication 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 row (Pain Management (Acute) in this example). 70

77 Indications menu 16 Therapy 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 therapy screen with the programme. 71

78 Saving a modified program 17 As described in the previous sections, the program 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 program Changing the parameters The change is shown in the title bar (AB 00 modified). 72

79 Saving a modified program 17 Opening the memory list Press the button to open the screen to enter the program 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 the program name. Note: When entering a custom program name, the name in the input field must first be deleted. 73

80 Saving a modified program Fast Path Saving 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 in the list. F: Fast Path 00: Program number in the list 74

81 Saving a modified program Memory Saving a 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 in the list. S: Memory 00: Program number in the list 75

82 Retrieving and editing Fast Path and memory Retrieving Fast Path 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. Selecting therapy Select the desired program by pressing on the appropriate row. 76

83 Retrieving and editing Fast Path and memory Editing Fast Path 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 appropriate arrow keys to move the program up or down in the sequence. 77

84 Retrieving and editing Fast Path and memory Editing Fast Path 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. 78

85 Retrieving and editing Fast Path and memory Retrieving and editing memory Selecting Memory Press the button to open the Memory. Selecting therapy Editing Memory Note: Select the desired program by pressing on the appropriate row. 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. 79

86 Explanation of symbols 19 In the Operating Instructions, this symbol stands for danger. Follow directions in the Operating Instructions at all times.! In the Operating Instructions this symbol stands for Caution with regard to possible 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. 80

87 General technical information 20 Soleo SonoStim / Soleo Stim Operating voltage Power consumption Protection class Mains fuse Applied part Dimensions Weight Transport Operational environment Storage Regulatory Compliance V, 220 V / 50/ 60 Hz max. 60 VA II 2 x 2 A T Type BF 12.7 in x 9.2 in x 5.1 in (322 mm x 234 mm x 130 mm) 4.6 lbs (2.1 kg) in original packaging only 50 F to 104 F (+10 C to + 40 C), 30% to 75% rel. humidity, hpa 50 F to 122 F (+10 C to + 50 C), 10% to 90% rel. humidity, hpa IEC/EN IEC/EN IEC/EN IEC/EN

88 Specific technical Information Stimulation current Monophasic Amplitude: Phase duration: Pause: Polarity: 0-50mA 200µs-1.5ms 0.5ms-10s Positive, negative or alternating High Voltage Amplitude: Frequency: Polarity: 0-180V Hz Positive, negative or alternating Micro current Amplitude: Frequency: Polarity: 0-1mA Hz Positive, negative or alternating Biphasic rectangular symmetric Amplitude: Phase duration: Pause: Frequency: Burst Frequency: 0-100mA 100µs-1ms 0.5ms-10s Hz 1-200Hz Middle Frequency Amplitude: Carrier Frequency: 0-100mA Hz Premodulated Interferential Amplitude: Carrier Frequency: Beat Frequency: Sweep low frequency: Sweep high frequency: Amplitude: Carrier Frequency: Beat Frequency: Sweep low frequency: Sweep high frequency: 0-100mA Hz 1-200Hz 1-100Hz Hz 0-100mA Hz 1-200Hz 1-60Hz Hz 82

89 Specific technical Information Ultrasound Ultrasound heads Frequency 0.8 MHz (800 kmhz) and 2.4 MHz Small ultrasound head 1 cm², ERA = 1.1 cm² at 0.8 MHz (800 kmhz), 0.5 cm² at 2.4 MHz Maximum output Intensity steps 1 W at 0.8 MHz (800 kmhz), 0.5 W at 2.4 MHz 0.1 to 1 W/cm² eff. in steps of 0.1 W / cm² Large ultrasound head5 cm², ERA = 2.3 cm² at 0.8 MHz (800 kmhz), 2.4 cm² at 2.4 MHz Maximum output Intensity steps 6.9 W at 0.8 MHz (800 kmhz), 7.1 W at 2.4 MHz 0.1 to 3 W/cm² eff. in steps of 0.1 W / cm² Accuracy < ± 20 % (This value represents the legally permissible value required by law, and not the actual accuracy level for each device) Ultrasound modes Note: Replacement parts 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 Duty cycle 1:10 only provides comfort heating Ultrasound heads are factory-calibrated and can be easily replaced. 83

90 Cleaning Disinfection 22 Housing Clean housing with standard alcohol-free plastic cleaner. Disinfect housing with standard alcohol-free disinfectant suitable for plastic. Screen Clean the screen with standard alcohol-free plastic cleaner. Disinfect the screen with standard alcohol-free disinfectant suitable for plastic. Ultrasound heads Clean the ultrasound heads with tap water. Disinfect the ultrasound heads with standard alcohol-free disinfectant suitable for plastic. 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 alcohol. 84

91 Electrodes Use and care All ordinary electrodes that are used in electrotherapy can be connected to the Soleoline by using isolated lead clips. Most successful are the disposable electrodes from Zimmer MedizinSystems. These electrodes are simple, quick, exact and hygienic. Plate electrodes and rubber electrodes are also available in addition to the disposable electrodes for large surface application. In order to avoid placing the bare plate electrodes directly onto the skin, the electrodes are surrounded by sponge pockets. The sponge pockets must be kept wet at all times 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 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 the sponge pockets. After the therapy session, the sponges should be cleaned well with water or with a disinfecting solution. Do not place electrodes on skin injuries. Even minor cracks or injuries are likely to cause burns and the patient will feel the current intensity differently. If this cannot be avoided, use zinc cream to cover sensitive areas. 85

92 Electrodes Information about the use of various electrode types General note Select and apply electrodes with care. In constant current operation, a good, even skin contact must be ensured. A reduction in the contact area may result in paraesthesia in patients. Before starting the treatment, the skin must be inspected and cleaned if necessary, e.g., if the patient is sweaty or has applied any cream. Inflamed skin, small wounds or scratches are covered with Vaseline or zinc cream. Particular caution is also advised for recent scarring. Disposable electrodes Self-adhering disposable electrodes allow comfortable and quick application. They are also hygienic due to their single use. Three therapeutically 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 household waste. Re-use of disposable electrodes may result in a hazard for the patient. Rubber electrodes Tin plate 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 normal removal of carbon resulting from use causes a reduction in the conductivity. For therapy with purely galvanic current (galvanisation, iontophoresis) large tin plate electrodes are suitable. Sponge holders and sponges Both rubber and zinc plate electrodes must always have a moist intermediate layer placed underneath. It 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 suitable. 86

93 Contents on delivery Accessories Soleo SonoStim Contents on delivery Soleo SonoStim Item No Soleo SonoStim device electrode cables, incl. 2 red and 2 black alligator clips, 2.90 m long, incl. magnetic clip variable frequency ultrasound head 0.8 and 2.4 MHz, ø 28 mm storage tray, right storage tray, left mains cable touch pens test resitances Accessories Item No Touch pen Mains cable Storage tray, right Storage tray, left Test resistance Electrotherapy electrode cables, incl. 2 red and 2 black alligator clips, 2.90 m long, incl. magnetic clip pair electrode cables, 2.90 m Alligator clip red 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) Ultrasound therapy 4200 Variable frequency ultrasound head 0.8 and 2.4 MHz, ø 5 cm 2 (28 mm) 4220 Variable frequency ultrasound head 0.8 and 2.4 MHz, ø 5 cm 2 (13 mm) 87

94 Contents on delivery Accessories Soleo Stim Contents on delivery Soleo Stim Item No Soleo Stim device electrode cables, incl. 2 red and 2 black alligator clips, 2.90 m long, incl. magnetic clip storage tray, right storage tray, left mains cable touch pens test resitances Accessories Item No electrode cables, incl. 2 red and 2 black alligator clips, 2.90 m long, incl. magnetic clip pair electrode cables, 2.90 m Alligator clip red 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) Touch pen Mains cable Storage tray, right Storage tray, left Test resistance 88

95 Safety and maintenance 25 Soleo SonoStim / Soleo Stim are produced in accordance with the safety requirements of IEC Zimmer MedizinSystems as the manufacturer can be responsible for the safety and reliability only in the following circumstances: if the device is operated from an approved earthed wall socket if the device is operated in accordance with the Operating Instructions if extensions, reconfigurations or modifications 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 ultrasound head, cables and connectors for damage (such as cracks) that could adversely affect the safety of the device the device must be operated by appropriately trained personnel only disconnect the device from the power supply immediately if it is exposed to liquids The unit is not designed for use in explosive or inflammable environments The device does not contain any parts that must be maintained or repaired by the operator. 89

96 Functional test 26 Soleo SonoStim / Soleo Stim runs a self-test that checks all internal components after it is switched on. An error message is shown in case of faults. An extended functional test can also be run in all three operating modes as described below. These tests should be run once a month or if there is any doubt about the operational reliability of the device. Stimulation current Ultrasound 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. 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. 90

97 Technical safety checks 27 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. 91

98 Error messages Troubleshooting Disposal 28 Cable check With stimulation current therapy in continuous current mode: the patient current circuit is broken. This message generally indicates failed electrodes, dirty electrode terminals 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 again, contact customer service. 92

99 Error messages Troubleshooting Disposal 28 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. Error The screen shows: In some cases, the error can be cleared 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. The device must be sent to the factory in the original packaging only. Head office Disposal Zimmer MedizinSystems 25 Mauchly Suite 300 Irvine, CA The device must be disposed of by an approved disposal company and must not be discarded with household or special waste. 93