Front View 3 2. Selection and Operating Elements

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3 Front View Selection and Operating Elements 1 On and Off switch 2 Navigation keys 3 Title bar 4 Keys on screen 5 Channel I intensity regulator 6 Status bar 7 Channel II intensity regulator

4 Back View Connection Sockets 8 Transducer socket for 0.8 / 2.4 MHz transducer 9 Socket for channel II patient cable 10 Socket for remote control 11 Connection for mains power cable 12 Socket for Ethernet 13 Socket for channel I patient cable 14 Transducer socket for 0.8 / 2.4 MHz transducer

5 Contents Front View Selection and Operating Elements Back View Connection Sockets Page 1. PhySys Summary 1 2. Cable Connection 2 3. Initial Operation 3 4. Basic Settings 4 5. Brief Instructions for Operation 5.1 Electrotherapy Ultrasound Therapy Combined Therapy (Electrotherapy + Ultrasound) Vacuum Electrotherapy Combined with Vacuum Note on VacoP Operation Selection Key Description in the Navigation Bars Electrostimulation Screenshots Electrostimulation 8.1 Display Description 51 8:2 Parameter Key Description Surge Key Description Modifying the Current Form Parameters Modifying the Surge Parameters Interference Display and Key Description SonoSwing Ultrasound Screenshots SonoSwing Ultrasound 10.1 Display Description Mode Key Description Depth Effect Key Description Combined Therapy Screenshot Vacuum Screenshot Display Description Electrotherapy Combined with Vacuum 79 Screenshot 13.1 Display Description Modifying Combination Parameters Indication Selection 14.1 By Body Region By Alphabetical Keyboard Saving a Modified Program 90

6 Contents 16. Favourite Program List 16.1 Creating Favourite Program List Editing Favourite Program List Memory 17.1 Run Edit Sequence Programs Programming 107 Paralysis Diagnostic and Therapy 19. Overview 109 Paralysis Diagnostic Programs 20.1 Medium Frequency Test according to Lange Neofaradic Test Chronaxie and Accommodation Quotients Calculating I/T Curves Comparing I/T Curves Deleting I/T Curves Fischgold Test Paralysis Therapy Programs 21.1 Flaccid Paralysis Therapy Program PA Flaccid Paralysis Therapy with the Average Value Method 131 according to Steuernagel Program PA Indications Contraindications Symbol Explanation Warnings Technical Information 26.1 General Stimulation Current Ultrasound Vacuum Cleaning, Disinfection Electrode Handling Declaration of Conformity Delivery Scope, Accessories Device Combinations Safety and Maintenance Automatic Functional Test Safety Checks Error Message, Troubleshooting, Disposal Manufacturer's Declaration of Electromagnetic Compatibility (EMC) 157 Applicable for devices from software version 2.1. This Instructions for Use, PhySys is a component of the device. It must be kept with the device and must be accessible to persons appointed to operate the device.

7 PhySys Summary 1. What is PhySys? What does PhySys do? Why is PhySys useful? A modern, extremely innovative combination device for electrotherapy and ultrasound therapy with the option of an additional vacuum unit. It provides monophasic, biphasic and medium-frequency currents for nerve stimulation and muscle therapy in 1-channel and 2-channel mode, as well as therapeutic ultrasound. A large colour display presents all parameters relevant to therapy for operation via touch-screen technology. Individual program start settings and simple menu navigation offers maximum convenience for the user. The combination of electrotherapy and ultrasound therapy in one system facilitates the use of proven simultaneous therapy. The integration and use of the vacuum unit enables comfortable electrode attachment and provides an additional pleasant massage effect for the patient. Innovations of PhySys? SonoSwing, the innovation in ultrasound therapy: - one transducer with 2 frequencies - selectable penetration depth with percentage setting of the frequency components. The separate dosage of mechanical and thermal effects means that the effects can be individually selected. The user is free to decide whether a thermal effect or rather a micro massage is required. Note: The device is designed for use by medically trained personnel only (e.g. physicians, therapists, auxiliary medical professionals). 1

8 PhySys Cable Connection 2. Electrostimulation Connect the patient cable for channel 1 to the specified socket (13). Connect the patient cable for channel 2 to the specified socket (9). Connect the plug on the end of the electrode cable (red plug in red socket, black plug in black socket) to the channel 1 patient cable. Connect the plug on the end of the electrode cable (red plug in red socket, black plug in black socket) to the channel 2 patient cable. SonoSwing Connect the transducers to the specified sockets (8 and/or 14). Note: Vacuum unit The vacuum unit is integrated into the stand as a pull-out unit. Please see the separate installation manual for installation of the vacuum unit in the stand, the connection of the vacuum unit to the PhySys tabletop device and attaching the PhySys tabletop device. Connect the red Vaco electrode sleeve to the socket on the back of the stand: circuit 1, anode on. Connect the black Vaco electrode sleeve to the socket on the back of the stand: circuit 1, cathode on. Connect the red Vaco electrode sleeve to the socket on the back of the stand: circuit 2, anode on. Connect the black Vaco electrode sleeve to the socket on the back of the stand: circuit 2, cathode on. Connect the Vaco electrodes to the free end of the Vaco electrode sleeves with the plug. 2

9 PhySys Initial Operation 3. Connect mains supply Switch on device Transducer calibration Connect the mains supply cable to the relevant socket (11) and connect the cable to the mains supply. Switch the device on with the toggle switch on the right under the screen. When the transducer is connected, a prompt to calibrate the transducer appears when the device is switched on. Calibrate the transducer as described in Section 4, Coupling calibration. Note: All keys, menus and submenus are activated on screen by touching them with a finger or the touch pen. 3

10 PhySys Basic Settings 4. Note: Note: Start screen The following descriptions refer in all cases to therapy with one channel and are based on the default factory settings. The basic settings can only be modified from the start screen. The start screen appears after switching on the device and after the automatic self-test. Selecting basic settings Press to open the configuration menu. 4

11 PhySys Basic Settings 4. Configuration menu Factory settings can be modified and customised in the configuration menu. After activation of the configuration menu the General settings screen is active. General Settings Program start settings, language, welcome text and much more can be customised. The default settings are programmed in the factory as shown on the screen. Language The language is selected from the relevant row. 5

12 PhySys Basic Settings 4. Program start settings Options for program start settings. The desired program start setting is selected in the relevant row. Start screen Option for selecting one of two start screens. The selection is made in the relevant row. Display time start screen Option for setting the display time for the start screen (0 seconds here) using the two arrow keys. After the start time has lapsed, the initial screen selected is automatically opened. If the time is set to 0 seconds, the start screen remains visible until the Immediate start button is activated. 6

13 PhySys Basic Settings 4. Audio settings Option for setting the volume of the signal tones using the two arrow keys. Pitch Option for setting the pitch of the signal tones using the two arrow keys. Welcome Press to open an alphabetical keyboard for input of a customised welcome text. Brightness Option for setting the screen brightness using the two arrow keys. 7

14 PhySys Basic Settings 4. Touch calibration Touch calibration can be used to recalibrate the keys on the screen. Press to open the Touch Calibration window. Follow the instructions on the screen exactly to carry out a touch calibration. Standard settings Press to restore the standard settings. Network Press to open the network menu. Note: The network menu may be accessed by technicians only. The procedure is described in the Service Manual. 8

15 PhySys Basic Settings 4. Therapy settings Press to open the Therapy settings screen. Therapy settings can be made here. Electrostimulation Option for setting the display mode of the electrostimulation programs. The selection is made in the relevant row. 9

16 PhySys Basic Settings 4. Polarity reversal cycle Option for setting the polarity reversal time using the two arrow keys. Therapy time Option for setting a unified therapy time for all programs using the two arrow keys. SonoSwing Options for the intensity unit on the bar graph. The selection is made in the relevant row. Coupling signal Option for setting the coupling limit value using the two arrow keys. 10

17 PhySys Basic Settings 4. Transducer calibration The transducers can be calibrated to compensate for possible miscalibrations of the transducers resulting from extended operating times. Press to open the transducer calibration menu. Note: Preparation If PhySys is fitted with two transducers and both transducers are connected, both are highlighted in blue and are active for the calibration. Calibrate the two transducers one after the other. If only one transducer is connected, only the key of the connected transducer is highlighted in blue and active for the calibration. The second key of the unconnected transducer is shaded and inactive. Have a container of water ready. Follow the instructions on screen exactly. 11

18 PhySys Basic Settings 4. Transducer calibration Place transducer in water. When the transducer is fully submerged in the water press OK. The window closes and the calibration starts. A new window opens after the first calibration step. Remove transducer from the water and dry thoroughly. Then press OK. Another window indicates that the calibration is complete. Press OK and, if applicable, calibrate the other transducer in the same way or return to the start screen. 12

19 PhySys Basic Settings 4. Vacuum Options for the intensity unit for the negative pressure. The selection is made in the relevant row. 13

20 PhySys Basic Settings 4. Press to open the window to save the settings. Save settings Press to save the modified settings and return to the start screen. Do not save settings Press to reject the modified settings and return to the start screen. Cancel Press to cancel the procedure. After cancelling the procedure, either select new settings and save them or return to the start screen. 14

21 Brief Instructions for Operation Electrotherapy Program start Press to open the Programs Electrostimulation window. Programs Electrostimulation In the Programs Electrostimulation menu, the current forms are classified by current groups. 15

22 Brief Instructions for Operation Electrotherapy Select current forms group The current form group is selected in the relevant row. Select current form The desired current form is selected in the relevant row. 16

23 Brief Instructions for Operation Electrotherapy Therapy screen After the current form has been selected, the therapy screen opens automatically in channel 1. Therapy start When the intensity is adjusted with the intensity regulator to the left, the display in the lower status bar changes from Ready to Active and the therapy proceeds. The bar graph shows the actual current flow and the remaining therapy time is shown in seconds. 17

24 Brief Instructions for Operation Electrotherapy End of therapy Once the therapy time has expired, an acoustic signal indicates the end of the therapy, the clock shows 00:00, the intensity is automatically set to zero and the bar graph display disappears. The display in the bottom status line switches from Active to Ready. Starting the therapy time Press to activate the therapy time after the end of therapy. 18

25 Brief Instructions for Operation Ultrasound Therapy Start screen The start screen appears after switching on the device and after the self-test. Program start Press to open the Programs Electrostimulation window. 19

26 Brief Instructions for Operation Ultrasound Therapy Press to open the Programs SonoSwing window. Select program The desired ultrasound therapy program is selected in the relevant row. 20

27 Brief Instructions for Operation Ultrasound Therapy Therapy screen After selecting the ultrasound therapy program the therapy screen opens. Note: The separate controls for mechanical and thermal effects enables the user to select the thermal effect or the mechanical (Micro-Massage) effect as the emphasis of the ultrasound therapy. To change the specified ratio as required, activate the desired bar graph directly in the bar graph display. The blue bar under the blue dot indicates the active bar graph. 21

28 Brief Instructions for Operation Ultrasound Therapy Setting intensity Adjust the intensity with the intensity regulator to the left. Therapy start Click the key to start the therapy. The display in the bottom status line switches from Ready to Active when therapy starts. The specified dosage is displayed in the two bar graphs and the remaining therapy time is shown in seconds. The coupling display is active. 22

29 Brief Instructions for Operation Ultrasound Therapy End of therapy Once the therapy time has lapsed, an acoustic signal indicates the end of the therapy and the clock shows 00:00. The intensity is automatically set to zero, the bar graph display closes and the coupling display is inactive. The display in the bottom status bar switches from Active to Ready. Starting the therapy time Press to activate the therapy time again at the end of therapy. 23

30 Brief Instructions for Operation Combined Therapy (Electrotherapy + Ultrasound) Start screen The start screen appears after the device is switched on and the self-test has run. Program start Press to open the Programs Electrostimulation window. 24

31 Brief Instructions for Operation Combined Therapy (Electrotherapy + Ultrasound) Press to open the Programs Combined window. Select program The desired combined therapy program is selected in the relevant row. 25

32 Brief Instructions for Operation Combined Therapy (Electrotherapy + Ultrasound) Therapy screen After selecting the combined therapy program, the therapy screen opens. Setting ultrasound intensity Adjust the intensity with the intensity regulator to the left. 26

33 Brief Instructions for Operation Combined Therapy (Electrotherapy + Ultrasound) Therapy start Adjust the intensity with the intensity regulator to the right to activate combined therapy. Setting stimulation current intensity The display in the lower status bar switches from Ready to Active. The defined ultrasound dosage is displayed in the left bar graph and the coupling display is active. The actual current flow is displayed in the right bar graph. The remaining therapy time is shown in seconds. Note: In combined therapy, the anode is only active on Channel

34 Brief Instructions for Operation Combined Therapy (Electrotherapy + Ultrasound) End of therapy Once the therapy time has lapsed, an acoustic signal indicates the end of the therapy and the clock shows 00:00. The intensity is automatically set to zero, the bar graph display closes and the coupling display is inactive. The display in the lower status bar switches from Active to Ready. Starting the therapy time Press to activate the therapy time again at the end of therapy. 28

35 Brief Instructions for Operation Vacuum Start screen The start screen appears after switching on the device and after the self-test. Program start Press to open the Programs Electrostimulation window. 29

36 Brief Instructions for Operation Vacuum Press to open the Vacuum window. Activating start vacuum The factory setting for the start vacuum is 16 kpa. Press to activate the start vacuum for aspiration of the Vaco electrodes. 30

37 Brief Instructions for Operation Vacuum Activating vacuum The vacuum unit is active when the start vacuum is activated. The display in the lower status bar switches from Ready to Active. The bar graph shows the value of the start vacuum and the remaining time is shown in seconds. Setting vacuum The vacuum is adjusted using the right and left arrow keys adjacent to the therapy window. 31

38 Brief Instructions for Operation Vacuum Vacuum screen After setting the vacuum, the bar graph shows the current vacuum value. End of vacuum Once the time has lapsed, an acoustic signal indicates the end of the therapy, the clock shows 00:00, the vacuum value is automatically set to zero and the bar graph display disappears. The display in the bottom status bar switches from Active to Ready. 32

39 Brief Instructions for Operation Vacuum Activating the time Press to activate the time after the end of therapy. Note: Because the vacuum unit is in most cases used in combination with electrostimulation, the pause button is not active in single mode. 33

40 Brief Instructions for Operation Electrotherapy Combined with Vacuum Note: Until the therapy screen, the procedure is identical to that described in Section 5.1 Electrostimulation. Open vacuum menu Activate the field to open the vacuum menu. 34

41 Brief Instructions for Operation Electrotherapy Combined with Vacuum Activating start vacuum The factory setting for the start vacuum is 16 kpa. Press to activate the start vacuum for aspiration of the Vaco electrodes. The vacuum unit is active when the start vacuum is activated. The start vacuum value is displayed in the bar graph. Select vacuum Set vacuum using the two keys. After setting the vacuum the bar graph shows the current vacuum value. 35

42 Brief Instructions for Operation Electrotherapy Combined with Vacuum Start electrostimulation therapy The intensity regulator to the left changes the display in the lower status bar from Ready to Active and the therapy proceeds. The bar graph shows the actual current flow and the remaining therapy time is shown in seconds. End electrostimulation Therapy Once the therapy time has lapsed, an acoustic signal indicates the end of the therapy, the clock shows 00:00, the intensity is automatically set to zero and the bar graph display disappears. The display in the lower status line switches from Active to Ready. Note: The vacuum must be terminated manually after completion of treatment with Start/Stop key. 36

43 Brief Instructions for Operation Electrotherapy Combined with Vacuum Deactivating vacuum Press to deactivate the vacuum. Activating the time Press to activate the therapy time again at the end of therapy. 37

44 Brief Instructions for Operation Note on VacoP Operation Draining water separator Important! VacoP is integrated into the stand and has an integrated water separator, which collects moisture from the sponges and protects the vacuum unit from calcification. Before draining the water separator, remove one of the Vaco electrodes from the tube. Drain the water separator by opening the drain valve. The drain valve is on the bottom of the VacoP. After draining the unit, close the valve again. Important! After draining the unit, make sure that the drain valve is at an angle of 90 to the direction of flow (see Fig.). It is recommend to drain the water separator daily. Important! VacoP and DuoStim separate mode In the DuoStim separate mode, a twin-circuit vacuum application is not possible. In the DuoStim separate mode, only Channel 1 is active for the vacuum application. Channel 2 cannot be used with vacuum application. 38

45 Selection Key Description in the Navigation Bars 6. Note! All descriptions below are based on the factory settings. Settings Click the key to open the settings menu. The options are described in detail in Section 4. Immediate Start Click the key to open the start screen. Favourites Click the key to open the favourites list. Programs Click the key to open the Electrostimulation programs list. 39

46 Selection Key Description in the Navigation Bars 6. Indications Click the key to open the indications menu. Two options are available: - select indication by body part - select indication by the alphabetical keyboard When the key is clicked, indication selection by body part is activated. Alphabet Click the key to open the indication selection by alphabetical keyboard menu. Body Parts Click the key to open the Indication selection by body parts menu. Memory Click the key to open the Program Memory screen. 40

47 Selection Key Description in the Navigation Bars 6. Channel Click the key to open the channel mode. 1. When the key is clicked, different channel mode selection options can be selected. 2. The channel mode can be changed again by clicking on the key from the therapy screen. Mode Group Activates MonoStim, 1-channel therapy. Exceptions are pre-programmed 2-channel currents, e.g. interference currents. Activates TwinStim, 2-channel therapy. The same 1-channel current form runs on both channel 1 and channel 2. Activates DuoStim, 2-channel therapy. Different 1-channel current forms run on channel 1 and channel 2. Channel Group In MonoStim mode, channel 1 or channel 2 can be activated for the next therapy. Activates channel 1, channel 1 is active. Activates channel 2, channel 2 is active. Click the key to switch from channel 1 to channel 2 and vice versa. Can only be activated from the therapy screen. 41

48 Selection Key Description in the Navigation Bars 6. Synchronisation Group The surge is defined here for TwinStim and DuoStim modes. Alternating activation: The current forms are started and stopped simultaneously on both channels. The surges are counter-phase. Parallel activation: The current forms are started and stopped simultaneously on both channels. The surges are simultaneous. Separate activation: The current forms are started and stopped separately on both channels. The surges are independent of one other. Can only be activated in DuoStim mode. Click the key to select a different current form for channel 1. Can only be activated from the therapy screen. Click the key to select a different current form for channel 2. Can only be activated from the therapy screen. 42

49 Selection Key Description in the Navigation Bars 6. Save Click the key to open the screen to save a program. Can only be activated from the therapy screen. Back Click the key to go back one screen. Can only be activated from the therapy screen. Home Click the key to return to the home screen. Edit Click the key - to open the memory programs for editing - to open the favouites list for editing - to open the diagnostic memory for editing Diagnostic Click the key to open the diagnostic memory. 43

50 Selection Key Description in the Navigation Bars 6. Insert Click the key - to open the program selection or the box to enter the program name - to import the program into the favourites list Overwrite Click the key to overwrite a saved program. Move Click the key to move the sequence up. Move Click the key to move the sequence down. Delete Click the key to delete the selected program from the list. 44

51 Selection Key Description in the Navigation Bars 6. Electrostimulation Click the key to open the electrostimulation programs list. SonoSwing Click the key to open the ultrasound therapy programs list. Combined Click the key to open the combined therapy programs list. Vacuum Click the key to open the vacuum for solo mode screen. Note: This key is only visible when a vacuum unit is connected. 45

52 Selection Key Description in the Navigation Bars 6. Scroll Click the key to scroll down the list. Scroll Click the key to scroll up the list. OK Click the key to accept changes. Cancel Click the key to reject changes. 46

53 Electrostimulation Screenshots 7. MonoStim TwinStim 47

54 Electrostimulation Screenshots 7. DuoStim alternating DuoStim parallel 48

55 Electrostimulation Screenshots 7. DuoStim separate 49

56 Electrostimulation Screenshots 7. Note: The Parameter, Surge and Vacuum elements become keys after activation. Title bar The title bar shows the channel mode and the name of the 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, hyperemia, relaxation and strengthening of the current form. Note: If the waveform parameters (pulse time or pulse pause) are changed, the effects of the current form also change. The window is therefore no longer visible after a change. 50

57 Electrostimulation Display Description Therapy time Indicates the total therapy time from therapy start Indicates the remaining time after therapy start Bar Graph of Intensity Indicates the currently specified intensity In CC mode: display in ma eff or peak. In CC mode: display in V peak. 51

58 Electrostimulation Display Description Vacuum 1. Signals the connection of the vacuum unit in the therapy screen. 2. Opens after activation of the vacuum settings and vacuum home screen, in which parameters can be changed, and vacuum solo and combination therapy with electrostimulation can be started. Note: This key is only visible when a vacuum unit is connected. 52

59 Electrostimulation Parameter Key Description Note: If the parameters key is activated during therapy, the therapy will be interrupted and the intensity returns to zero. The therapy time is stopped. The therapy is restarted for the remaining time by adjusting the intensity. Parameters 1. Sets the parameters of the current therapy program. 2. Activates Parameters of Current Form. For a detailed description see Section Frequency display 1.2 Graphic view of waveform 1.3 Polarity 1.4 CC / CV 1.5 Galvanic component Note: Modes 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 2 frequencies with animated display of the current intermediate frequency as a bar. 53

60 Electrostimulation Parameter Key Description 1.2 Waveform Graphic view of waveform. 1.3 Polarity Display of the polarity - positive only - negative only - polarity switches automatically Note: If the polarity switches automatically, the first polarity switch is factory-set for 45 seconds 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 galvanic component - 0%, 20%, 50% 54

61 Electrostimulation Surge Key Description Surge activated Indicates that a surge is activated and shows the parameters of the current surge rise time and hold time of the surge phase in seconds pause in the surge phase in seconds After activation of the surge window the surge parameters can be modified separately. For a detailed description see Section 8.5. Note: If the parameters key is activated during therapy, the therapy will be interrupted and the intensity will be set to zero. The therapy time is stopped. The therapy is restarted for the remaining time by adjusting the intensity. Surge deactivated When the surge is deactivated, the surge window is shown in minimised form. After activation of the surge window, a surge can be activated and the surge parameters can be set separately. For a detailed description see Section 8.5. Note: If there is no factory setting for a surge in a program, this window is not shown. 55

62 Electrostimulation Surge Key Description Surge inactive When the therapy is inactive, the surge is shown completely in blue. Surge active During therapy, the surge is animated to indicate the surge position. Surge mode alternating Alternating In two-channel mode, the alternating surge mode is shown by two arrows in the top left corner. Surge mode parallel Parallel In two-channel mode, the parallel surge mode is shown by two arrows in the top left corner. 56

63 Electrostimulation Modifying the Current Form Parameters Note: Only the parameters that are shown in the parameter window can be modified. Activating parameter key When the parameters window is activated, the Parameters of Current Form window is opened. Parameters of current form Adjustable parameters can be modified by the user here: 1. Pulse and pulse pause time of current form and resulting frequency 2. Polarity 3. CC / CV 4. Galvanic component The adjustable parameters are shown in blue and the fixed parameters are grey. 57

64 Electrostimulation Modifying the Current Form Parameters Parameter selection The parameter is selected by using the arrow keys. The parameter highlighted in blue can be modified. The Pulse time, in this case Note: Modifying parameters Modifications to the pulse and pulse hold time also modify the frequency. Use the arrow keys to increase or decrease the value within the limits specified in the current form definition. 58

65 Electrostimulation Modifying the Current Form Parameters Modifying polarity Click the key to modify the polarity of the current form. Switch CC / CV mode Click the key to switch the current form from CC/CV mode and vice versa. Galvanic component Click the key to reinforce the current form with a galvanic component or eliminate the galvanic component. 59

66 Electrostimulation Modifying the Current Form Parameters Save parameters Click the key to save the modified parameters. Cancel changes Click the key to reject changes. 60

67 Electrostimulation Modifying the Surge Parameters Activating surge key When the surge window is activated, the surge parameters window is opened. Surge parameters The surge parameters can be modified as follows by the user: Surge rise time shortest rise time longest rise time shortest hold time longest hold time rise time is constant shortest off time longest off time = 0 s: surge off : 0.5 s : 60 s : 0 s : 60 s : 0.5 s : 0.5 s : 60 s The rise time is constant at 0.5 s except for the currents for Russian stimulation (0.2 s). 61

68 Electrostimulation Modifying the Surge Parameters The duration of the surge phase is calculated from the duration of the rise time, hold time and down time. Select parameters The parameters that are to be modified are selected with the keys. 1. Rise time (2.0 s here) 2. Hold time (3.5 s here) 3. Off time (6.0 s here) The parameter highlighted in blue can be modified. Rise time in this case Modify parameters Use the keys to increase or decrease the value within the limits specified in the surge parameters definition. 62

69 Electrostimulation Modifying the Surge Parameters Save parameters Click the key to save the modified parameters. Cancel changes Click the key to reject changes. 63

70 Electrostimulation Interference Display and Key Description 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 modified 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 adjustment option of the intensity ratio of channel I and channel II (90% here). Adjustable from 0 100% in 5% steps. Note: The intensity is shown simultaneously for both circuits by using the intensity regulator knob to the left. 64

71 SonoSwing 9. Ultrasound Screenshots Thermal effect Mechanical effect 65

72 SonoSwing Ultrasound Display Description Title bar The title bar shows the channel mode and the identification 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. Mode 1. Displays data from the current transducer. 2. Opens the Ultrasound Mode window. For a detailed description see Section Transducer and size of transducer 1.2 Operating mode / pulse time / pulse frequency 66

73 SonoSwing Ultrasound Display Description 1.1 Transducer Graphic view of active transducer Large transducer 1.2 Operating mode Pulse time Pulse frequency Display of continuous operating mode or pulsed operating mode showing the pulse time (2 ms here) and the pulse frequency (50 Hz here) Depth effect The bar graph shows the current frequency ratio of 0.8 MHz to 2.4 MHz as a percentage. In this example: 50% 2.4 MHz 50% 0.8 MHz 67

74 SonoSwing Ultrasound Display Description Coupling The coupling is displayed graphically in different colors depending on the coupling value and 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 and when the coupling is sufficient the therapy will continue. Bar graph Thermal effect Mechanical effect Indicates the currently specified intensity. Display in W/cm² eff Display in W/cm² peak 68

75 SonoSwing Ultrasound Display Description Note: Dosing Thermal effect Mechanical effect The US 00 US 03 and US 09 programs output continuous ultrasound and therefore have a thermal effect. In the therapy screen, only the thermal effect graph is shown and it must be metered there. The thermal effect and the mechanical effect can be selected individually with the pulsed programs depending on whether the thermal effect or the mechanical effect is preferred in the ultrasound therapy. Activation of bar graph Activate the desired bar graph in the bar graph display to change the factory-set ratio. Bar graph activated The bar at the bottom of the bar graph display indicates that the bar graph is activated (thermal effect in this case). 69

76 SonoSwing Ultrasound Mode Key Description Note: Note: Activating mode key If the mode key is activated during therapy and parameters are modified, the therapy will be interrupted and the intensity will be set to zero. The therapy time is paused. The therapy is restarted for the remaining time by adjusting the intensity and pressing the start button. Only the parameters that are shown in the parameter window can be modified. When the mode window is activated, the Ultrasound Mode window is opened. Ultrasound mode The current transducer and the ultrasound modes can be selected. Note: If only one transducer is connected, the field for the second transducer is deactivated and shaded grey. 70

77 SonoSwing Mode Key Description Selecting transducer The desired transducer is selected directly in the display. Selecting mode The desired mode is selected directly in the display. Four different modes with the following pulse times and pulse frequencies can be selected: 71

78 SonoSwing Mode Key Description Save mode Click the key to save the modified parameters. Cancel modifications Click the key to reject modifications. 72

79 SonoSwing Depth Effect Key Description Adjusting treatment depth The frequency ratio is adjusted from 0.8 MHz to 2.4 MHz to adjust the treatment depth using the two arrow keys to the right of the treatment depth display window. 73

80 Combined Therapy Screenshot 11. Note: The keys and functions on the Simultaneous therapy screen are exactly the same as those in the Electrostimulation and SonoSwing therapy screens and have been described in the previous sections. This makes it unnecessary to describe this therapy screen in detail. 74

81 Vacuum Screenshot 12. Vacuum 75

82 Vacuum Display Description Title bar The title bar indicates the active operating mode. Status bar The status bar displays information on the current status. If the vacuum is not active, it shows the word Ready. If it is active, it shows the word Active. Pulse Indicates the current operating mode, continuous or pulsed. For a detailed description see Section

83 Vacuum Display Description Start vacuum Indicates the default start vacuum. Vacuum Indicates the specified vacuum. Bar graph Indicates the currently specified intensity during operation. 77

84 Vacuum Display Description Modifying start vacuum A start vacuum of 16 kpa for suction of the Vaco electrodes is set at the factory. The start vacuum can be increased or reduced to 12 kpa using the arrow keys to the left and right of the Start Vacuum window. Continuous mode The factory setting is continuous mode. Pulse mode The pulse duration is set using the arrow keys in the Pulse window. The pulse time can be set from 1.0 s to 8.0 s. Vacuum The vacuum is set using the arrow keys to the right and left of the Therapy window. 78

85 Electrotherapy Combined with Vacuum 13. Screenshot Note: The electrostimulation displays and keys have been described in detail in the preceding sections and only the vacuum displays and button are described in this section. Electrostimulation combined with vacuum 79

86 Electrotherapy Combined with Vacuum Display Description Vacuum Signals the connection of the vacuum unit in the therapy screen. Parameters Displays the parameters of the factory settings. 1. View of start vacuum as bar graph 2. Operating mode, continuous in this case 3. Numeric display of start vacuum Start vacuum activated Display in the bar graph indicates activation of start vacuum. 80

87 Electrotherapy Combined with Vacuum Modifying Combination Parameters Modifying vacuum parameters Click the key to open the vacuum input window for setting the vacuum parameters. Continuous mode The factory setting is continuous mode. Pulse mode The pulse duration is set using the arrow keys in the Pulse window. 81

88 Electrotherapy Combined with Vacuum Modifying Combination Parameters Modifying start vacuum The start vacuum is increased or decreased using the arrow keys to the left and right of the Start Vacuum window. Vacuum The vacuum is set using the arrow keys to the right and left of the Therapy window. 82

89 Electrotherapy Combined with Vacuum Modifying Combination Parameters Save parameters Click the key to save the modified parameters. Cancel modifications Click the key to cancel the modifications. Both keys close the parameter window when clicked and open the vacuum start screen. 83

90 Indication Selection By Body Region The Indication menus help you to select the therapy. The indication can be selected using the body region menu or the alphabetical keyboard. Indications Click the key to open the Selection by body region window. Selection by body region Click on a blue circle to select a body region. 84

91 Indication Selection By Body Region Indication selection After selecting the desired body region (shoulder in this example), the Indications window opens displaying various indications in the shoulder region. The indications are selected by clicking on the relevant row. Shoulder-arm syndrome in this case. Selection of detailed indications After selection of the indications another window opens showing detailed indications. The detailed indications are selected by clicking on the relevant row (subacute pain status in this example). 85

92 Indication Selection By Body Region Therapy information After selection of the detailed indications another window opens showing detailed therapy information and a suggested program. Selecting therapy program Click the key to open the therapy screen with the program. 86

93 Indication Selection By Alphabetical Keyboard Indications Click the key to open the window to make the selection by alphabetical keyboard. Input indications The indications are input using the keyboard (epicondylitis in this example). The indications are shown above the keyboard. Note: The indications can also be selected by clicking on the line above the keyboard. 87

94 Indication Selection By Alphabetical Keyboard Indication selection The indications are selected by clicking on the row. Selecting detailed therapy After selection of the indications another window opens showing detailed therapies. The detailed therapy is selected by clicking on the relevant row (pain treatment in this example). 88

95 Indication Selection By Alphabetical Keyboard Therapy information After selection of the detailed therapy another window opens showing detailed therapy information and a suggested program. Selecting therapy program Click the key to open the therapy screen with the program. 89

96 Saving a Modified Program 15. As described in the previous sections, the program parameters can be modified separately and saved. Note: The save procedure is similar for all types of therapy. Saving an electrostimulation program is described below. Select program and open therapy screen Parameter modified The change is shown in the title bar. 90

97 Saving a Modified Program 15. Open memory Click the key to open the memory. Select memory place The desired memory place is selected by clicking on the relevant row. 91

98 Saving a Modified Program 15. Input program Click the key to open the program name input box. Naming program Two options are available for naming a program. 1. Accept the program name in the input box. 2. Enter a specific program name. Enter your own program name using the keyboard. 92

99 Saving a Modified Program 15. Input program Click the key to save the program in the memory list. Add program to favourites When the program is saved in the memory, it can also be added to the favourites. Adds the program to the favourites list. Program is saved in the memory only. Cancels the procedure. 93

100 Favourite Program List Creating Favourite Program List A customised list of programs can be created. Twenty places are available. Note: Programs that have been added to the memory are also listed here. Open favourites Click the key to open the favourites list. Edit favourites Click the key to open the screen to add a program. 94

101 Favourite Program List Creating Favourite Program List Select memory place The desired memory place is selected by clicking on the relevant row. Insert Click the key to open the Currents Group screen. Select currents group Select current form The currents group is selected by clicking on the desired row. The current form is selected by clicking on the desired row. 95

102 Favourite Program List Creating Favourite Program List Add current form to favourites list When the current form is selected it is automatically added to the favourites list. Close edit window Click the key to close the favourites window. Therapy The desired therapy program is selected by clicking on the desired row. 96

103 Favourite Program List Editing Favourite Program List Programs can be added, deleted, overwritten and re-arranged here. Adding a program is described in detail in the previous section. Edit favourites Click the key to open the screen to edit a program in the favourites. Select program The program to be edited is selected by clicking on the desired row. 97

104 Favourite Program List Editing Favourite Program List Insert Click the key to add a new program to an occupied memory place. The original program is moved to the next free memory place. Overwrite Click the key to overwrite the old program with a new program. The original program is deleted. Change sequence Click the arrow keys to move the sequence up or down. 98

105 Favourite Program List Editing Favourite Program List Delete program Click the key to delete the saved program. Prompt Delete program? Delete program. Do not delete program. Cancels the procedure. 99

106 Memory Run The saved programs are listed in the memory. From here they can be: 1. retrieved for therapy or 2. edited (sequence changed and deleted). Select memory Click the key to open the memory. Therapy The desired therapy program is selected by clicking on the desired row. 100

107 Memory Edit Edit memory Click the key to open the Memory screen. Select program The program to be edited is selected by clicking on the desired row. Change sequence Click the arrow keys to move the sequence up or down. 101

108 Memory Edit Delete program Click the key to delete the saved program. Prompt Delete program? Delete program. Do not delete program. Cancels the procedure. 102

109 Sequence Programs 18. Sequence programs are a compilation of up to three therapy programs that can be run in sequence. Various programs are factory-defined in the Currents programs for sports rehabilitation. They generally consist of warmup, training, strengthening and relaxation phases. A freely programmable program is also available. Therapy screen pre-programmed program Sequence list Displays the three phases of the sequence program. The active phase is shown in blue. Therapy Time A therapy time is specified for all three phases. The upper time shows the remaining time for the current phase. The lower time shows the total remaining time. 103

110 Sequence Programs 18. Note: Because different pulse shapes and frequencies mean different sensitivity to current, the intensity surges are defined for the various sequences prior to therapy. Define intensities Sequence 1 Warm-up phase Sequence 1 is highlighted in blue, meaning that it is active. Define the intensity for sequence 1 using the two intensity regulators. Sequence 2 General muscle strengthening Sequence 2 is selected by clicking in the list. Sequence 2 is highlighted in blue, meaning that it is active. Define the intensity for sequence 2 using the two intensity regulators. 104

111 Sequence Programs 18. Sequence 3 Stretching phase Sequence 3 is selected by clicking in the list. Sequence 3 is highlighted in blue, meaning that it is active. Define the intensity for sequence 3 using the two intensity regulators. Note: After defining the intensities, the therapy time runs through the various sequences. When the next sequence is activated, the predefined intensity of the prior sequence is automatically saved. Activate sequence 1 When the intensities of all three sequences have been defined, sequence 1 in the list is activated. At the same time, the therapy time is reset to the predefined value and the start key becomes active. 105

112 Sequence Programs 18. Start of treatment Click the key to start the therapy. The three sequences run in succession. The change of sequence is signalled by an acoustic signal. End of treatment When the therapy time has finished, an acoustic signal sounds. 106

113 Sequence Programs Programming An individual sequence program can be defined under selection SR 07 in the Currents for sports rehabilitation programs. Note: Sequence programs can be defined in MonoStim and TwinStim mode. The freely definable sequence program is defined in MonoStim mode at the factory. TwinStim must be activated in channel mode to program a TwinStim program. Define sequence program Select sequence The factory setting is that the first sequence is active when the program is selected. The desired sequence is selected by clicking on the desired row and is highlighted in blue after activation. The Current form groups screen opens when the sequence for programming is selected. 107

114 Sequence Programs Programming Select current form group Select current form Sequence 1 Selection of the desired current form group. Selection of the desired current form. When the desired current form is selected, it is added to the sequence program and saved at the activated sequence slot. Define sequence 2 and 3 Sequence 2 and 3 are defined using the same procedure. Freely definable sequence training screen Note: The definition of intensities and therapy initiation are described in detail in the previous section. 108

115 Paralysis Diagnostic and Therapy Overview 19. PhySys includes special programs for diagnostics and therapy of paresis and flaccid paralysis. The diagnostic programs provide indications for assessment of the severity of a flaccid paralysis and make it easy to individually define the parameters for treatment of the specific patient. Diagnostic programs PA 00 Medium frequency innervation test according to Lange PA 01 Neofaradic test PA 02 Chronaxie and accommodation quotient PA 03 I/T curve PA 15 Fischgold test Various programs with all the pulse shapes required for paralysis therapy are available. The parameters can be modified for the patient depending on the medical history. Therapy programs PA 04 Therapy of flaccid paralysis PA 05 Paralysis treatment with bidirectional currents PA 06 Paralysis treatment with triangular impulse currents (alternating) PA 07 Paralysis, moderate degeneration PA 08 Paralysis, slight degeneration PA 09 Functional muscle stimulation (biphasic) PA 10 Intention exercises (biphasic) PA 11 Muscle rehabilitation for strength (biphasic) PA 12 Muscle rehabilitation for endurance (biphasic) PA 13 Muscle rehabilitation for strength and endurance (biphasic) PA 14 Therapy of spastic paralysis 109

116 Paralysis Diagnostic Programs Medium Frequency Test according to Lange The Lange medium frequency test gives a general indication of whether a muscle is partially or totally denervated. The electrodes are positioned on the muscle for testing. Screenshot Process Set an appropriate intensity and trigger a single pulse. Then the test is repeated on healthy muscle. If the two muscles have approximately the same excitability to the single pulse, the muscle in question is innervated. If there are significant differences in the reaction of the muscles to high excitation intensities, the muscle in question is partially denervated. 110

117 Paralysis Diagnostic Programs Neofaradic Test The neofaradic test indicates whether a muscle is normally innervated. A muscle is normally innervated if it reacts with a contraction equal in length to an excitation time of one minute. An innervation disorder can be assumed if no contraction or only a short contraction is observed. View of the screen Process The excitation time is started at one minute by regulating the intensity. 111

118 Paralysis Diagnostic Programs Chronaxie and Accommodation Quotients This program is used to conduct a simple and quick diagnosis. It consists of three steps that measure the rheobase, chronaxie and accommodation threshold, from which the accommodation quotient is calculated. After measurement, the values can be saved in the diagnostic memory for later analysis. Screenshot Rheobase Surge current magnitude for triggering a minimum muscle twitch with a square-wave pulse of 1000 ms. Process Calculating rheobase Step 1 : Step 2 : Set an appropriate low intensity. Trigger single pulse. Repeat steps 1 and 2 with increasing intensity until a minimum muscle twitch is observed. The rheobase value is calculated using the first minimum muscle twitch. 112

119 Paralysis Diagnostic Programs Chronaxie and Accommodation Quotients Step 3 : Accept rheobase value. When the calculated pulse is accepted, the intensity is automatically set to double the rheobase value. The intensity cannot be modified in this step. Chronaxie Pulse duration for triggering a minimum muscle twitch at a surge current strength that is double the rheobase value. Calculating chronaxie Step 1 : Increase pulse time in stages (if applicable, also reduce). Step 2 : Trigger single pulse. Repeat steps 1 and 2 until a minimum muscle twitch is observed. The chronaxie value is calculated using the first minimum muscle twitch. 113

120 Paralysis Diagnostic Programs Chronaxie and Accommodation Quotients Step 3 : Accept chronaxie value. Accommodation threshold Accommodation quotient DIC RIC Surge current magnitude for triggering a minimum muscle twitch with a triangular pulse of 1000 ms. Surge intensity (ma) of the DIC at 1000ms Surge intensity (ma) of the RIC at 1000ms (rheobase) triangular pulse characteristic rectangular pulse characteristic Calculate accommodation threshold Step 1 : Step 2 : Set an appropriate low intensity. Trigger single pulse. Repeat steps 1 and 2 with increasing intensity until a minimum muscle twitch is observed. The accommodation threshold is calculated using the first minimum muscle twitch. Step 3 : Accept accommodation threshold value. 114

121 Paralysis Diagnostic Programs Chronaxie and Accommodation Quotients Accommodation quotient When the value of the accommodation threshold is accepted, the accommodation quotient is automatically calculated. The calculated values are shown in a window. Evaluation of chronaxie < 0.05 ms Hyperexcitability ms Normal excitability 1 20 ms Partial degeneration > 20 ms Complete degeneration Normal chronaxie values (Edel) Anterior muscles (front of body) Proximal: ms Distal: ms Posterior muscles (back of body) Proximal: ms Distal: ms Evaluation of the accommodation quotient according to Edel 6 3: normally functioning neuromuscular system 3 2: slight or partial degeneration 2 1: severe or total degeneration 115

122 Paralysis Diagnostic Programs Calculating I / T Curves The I/T curve is a diagnostic program used to determine the current strength for minimum muscle twitch. It is used to determine how severe the muscle damage is and the pulse with which it can be treated. The measurement is conducted in two phases: In phase 1 the threshold current strength for triggering a minimum muscle twitch is measured using a rectangular pulse. The pulse duration is 1000 ms and can be reduced as defined by the user. Measurement phase 1 Step 1 : Regulate intensity. Step 2 : Trigger single pulse. Repeat steps 1 and 2 with increasing intensity until a minimum muscle twitch is observed. The rheobase value is calculated using the first visible muscle twitch. Step 3 : Accept rheobase value. 116

123 Paralysis Diagnostic Programs Calculating I / T Curves The rheobase value is shown above the graph. When the rheobase value is accepted into the graph, the next shortest pulse time is selected. Note: The required measurement point and the required pulse time can also be manually selected using the arrow keys. Repeat steps 1 and 2 for each required pulse time until a minimum muscle twitch is observed. Step 1 again: Step 2 again: Adjust intensity, and Trigger single pulse. Accept the value when the minimum muscle twitch is observed. It may be necessary to reduce the intensity again to check that it is actually the minimum muscle twitch. 117

124 Paralysis Diagnostic Programs Calculating I / T Curves The current strength required to trigger a minimum muscle twitch is entered above the corresponding pulse duration and connected by a continuous line once the measured value is accepted. The measurements are continued until the chronaxie value has been calculated. The chronaxie value is shown above the graph. 118

125 Paralysis Diagnostic Programs Calculating I / T Curves In phase 2 the threshold current strength for triggering a minimum muscle twitch is determined using a triangular pulse. The pulse duration is 1000 ms and can be reduced as defined by the user. Activation of measurement phase 2 The diagnostic screen for measurement phase 2 is activated from the parameter window. The following window opens: Measurement phase 2 Step 1 : Step 2 : Regulate intensity. Trigger single pulse. Repeat steps 1 and 2 with increasing intensity until a minimum muscle twitch is observed. The accommodation quotient is determined using the first visible muscle twitch. 119

126 Paralysis Diagnostic Programs Calculating I / T Curves Step 3 : Accept measured value. The accommodation quotient is shown above the graph. After acceptance of the accommodation quotient the next shortest pulse time is automatically selected. Note: The required measurement point can also be manually selected using the arrow keys. Step 4 : Trigger single pulse. Reduce the intensity with a stronger muscle twitch and trigger single pulses until the same muscle twitch is achieved. Select new measurement point and conduct the measurement as described. Run measurement until the lowest measurement point of the curve is reached. 120

127 Paralysis Diagnostic Programs Calculating I / T Curves The base point of the triangular pulse characteristic is reached at this pulse duration. A triangular pulse whose duration corresponds to the base point is used for therapeutic stimulation. 121

128 Paralysis Diagnostic Programs Comparing I / T Curves Monitor characteristic Two I/T curves can be compared for a better monitoring of the curve s characteristics. Two options are available: - compare I/T curves from the diagnostic memory - compare I/T curves immediately after saving them Note: Note: The curves must be saved before the characteristics can be monitored. Saving an I/T curve is a similar process to that of other programs and is described in detail in previous sections. Comparing curves from diagnostic memory 1. Open memory and select diagnostics. 2. Select curve. 122

129 Paralysis Diagnostic Programs Comparing I / T Curves 3. Click the Open key and select the curve you want to compare in the memory. To compare specific points directly the cursor can be moved using the arrow keys. The measurements are shown in different colours to distinguish them. 123

130 Paralysis Diagnostic Programs Comparing I / T Curves Comparing curves after saving them Immediately after saving an I/T curve and closing the memory menu, the curve that has just been saved can be compared with another curve from the memory. Screenshot Compare performance 1. Click the key to open the screen in which the curves can be selected for comparison. 124

131 Paralysis Diagnostic Programs Comparing I / T Curves 2. Click the Open key and select the curve you want to compare in the memory. New measurement Click the key to open the screen in which a new I/T curve can be added. 125

132 Paralysis Diagnostic Programs Deleting I / T Curves Prompt delete I / T curve To prevent accidental deletions, a prompt appears before a curve can be deleted. 126

133 Paralysis Diagnostic Programs Fischgold Test This program is used to conduct a simple and quick diagnosis. The measurement is conducted in two phases: In phase 1, the intensity I1 of the first muscle twitch is calculated for a square-wave pulse of 1 ms pulse duration. In phase 2, the intensity I2 of the first muscle twitch is calculated for a square-wave pulse of 100 ms. The quotient FGq = I1 / I2 is shown as the result. Screenshot Conducting measurement phase 1 Step 1 : Step 2 : Set an appropriate intensity. Trigger single pulse. Repeat steps 1 and 2 with increasing intensity until a minimum muscle twitch is observed. Step 3 : Accept measured value. After acceptance of the measured value, the parameters for measurement phase 2 are automatically accepted. 127

134 Paralysis Diagnostic Programs Fischgold Test Conducting measurement phase 2 Conduct measurement phase 2 in the same way as phase 1. After the measurement, the calculated values are shown at the top right of the screen. Evaluation of quotients < 1.7: normally functioning neuromuscular system > 1.7: partial degeneration If one of the two intensities cannot be calculated, the degeneration is complete. 128

135 Paralysis Therapy Programs Flaccid Paralysis Therapy Program PA 04 The table below is used to select suitable current parameters for different degrees of flaccid paralysis. Brief overview of the severity of lesions Degree of lesion Pulse duration Pause duration most severe degeneration (-1000) 5000 severe degeneration moderate degeneration Screenshot Activate parameter window Activate the parameter window to set the therapy parameters. Screenshot of activated parameter window The pulse duration is selected after activation of the parameter window. 129

136 Paralysis Therapy Programs Flaccid Paralysis Therapy Program PA 04 Use the arrow keys to select rise time, pulse duration and pause duration. Process Step 1 : Set the pulse duration calculated from the I/T curve or taken from the tables. Step 2 : Select pause time and set the desired pause duration. Close the parameter window. Step 3 : Select intensity and trigger single pulse. Note: If single pulse therapy is not desired, and if the pulses are to be automatically triggered over a specific period, the time must be activated before the intensity is set. 130

137 Paralysis Therapy Programs 21.2 Flaccid Paralysis Therapy with the Average Value Method according to Steuernagel Program PA The Steuernagel average method is suitable for fast orientation and calculation of the therapeutically required pulse instead of using the I/T curve. However, an I/T curve is essential at the start of treatment. An I/T curve should also be created to monitor the progress of the treatment over longer intervals, about once a month, during the process of reinnervation. The average method is a time-saving and accurate method for calculating therapy pulses. Activate parameter window Activate the parameter window to set the therapy parameters. Screenshot of activated parameter window The pulse duration is selected after activation of the parameter window. 131

138 Paralysis Therapy Programs 21.2 Flaccid Paralysis Therapy with the Average Value Method according to Steuernagel Program PA Process Step 1 : Set desired pulse duration. Close parameter window. Step 2 : Select intensity and trigger single pulse until a clearly visible twitch of the paralysed muscle is seen. Do not modify current strength. Step 3 : Activate parameter window again. Select rise time. Step 4 : Reduce rise time in stages and the triangular pulse changes to become a trapezoid pulse. Close parameter window. Step 5 : Trigger single pulses until the healthy muscle twitches at an equivalent intensity. 132

139 Paralysis Therapy Programs 21.2 Flaccid Paralysis Therapy with the Average Value Method according to Steuernagel Program PA Steuernagel average calculation The rise time is subtracted from the pulse duration and yields the hold time. The hold time is halved and the result subtracted from the total pulse duration. Now the optimum rise time is calculated. Process Step 6 : Activate parameter window. Set the calculated rise time. Step 7 : Step 8 : Select pause duration. Set the desired pause duration. Close parameter window. Set therapy time and stimulation of the muscles using the parameters starts. Therapy duration The ideal therapy time depends on the status of the muscles (2 10 minutes). If the contractions diminish prematurely, the session must be terminated early (muscular fatigue). 133

140 Indications 22. Indications - Functional circulation disorders - Angioneuropathy - Acrocyanosis - Arterial occlusive disease (stage I / II a) - Sudeck's syndrome (stage III) - Treatment of facial nerves (as pre-treatment) - Widespread myalgia - Neuralgia - Neuritis - Polyneuropathy - Radicular syndrome - Nerve compression syndrome - Polyarthralgia - Chronic polyarthritis - Tendinitis and tendovaginitis - Venous ulcers - Neurotrophic ulcers - Delayed wound healing - Osteoporosis - Delayed bone healing - Muscular weakness - Arbitrary innervation weakness - Lack of muscular feeling - Musculature overload - Painful muscle spasms - Myofascial pain syndrome - Posttraumatic stress syndrome - Excess sweating on the hands and feet (palmar-plantar hyperhidrosis) 134

141 Contraindications 23. Relative contraindications Additional contraindications - Acute inflammation (local, systemic) - Arterial occlusive disease from stage IIb according to Fontaine - Suppurative processes - General infections - Malignant and benign tumours - Thrombophlebitis, phlebothrombosis - Risk of embolism - Cardiac pacemakers and other implanted electronic devices - Transcardial flow - Metallic implants in the current region when using galvanic or unipolar currents - Psychoses Muscular treatment with surged pulse groups is contraindicated with: - unconsciousness, disorientation - reflectory inhibition (e.g. in fractures) - muscular inflammation - if the stimulation current therapy triggers lasting pain - babies, toddlers - if spasticity increases - pregnancy Precautions with specific current forms Diadynamic current, Träbert's current: - careful dosage in cases of perception disorders Electroacupuncture: - no needle acupuncture with coagulation disorders 135

142 Symbol Explanation 24. Symbol Explanation In the Instructions for Use, PhySys, this symbol stands for danger. Follow instructions in the Instructions for Use, PhySys at all times.! In the Instructions for Use, PhySys, this symbol stands for Caution with regard to possible material damage. BF device type (as per IEC 601-1): Degree of protection from electric shock. Application on the heart is prohibited. The device is protection Class II (IEC) double-insulated. 136

143 Warnings 25. Please observe under all circumstances: Never connect two patients to the device in one treatment session! Electrotherapy For patients with implants or implanted electronic devices, only perform stimulation current treatment after clarifying the absence of risk. The Combined connection of the patient to a high frequency surgical device is not permissible. This can lead to burns beneath the stimulation current electrodes. The operation of the stimulation current device in close proximity of strong electromagnetic fields (e.g. tomographs, X-ray or diathermia devices) may trigger fluctuations in the output value of the stimulation current device. Please maintain a safety distance of several meters For currents presenting a corrosive hazard (e.g. galvanic current, diadynamic currents), the recommended current density is 2 ma eff/cm² electrode surface. If the current density of 2 ma eff/cm² is exceeded, the user should be increasingly cautious 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.! Note: The same warnings as above apply to vacuum application. If the intensity regulator is adjusted high, currents above 10 ma eff. can flow or voltages above 10 V may be present at the output sockets. 137

144 Warnings 25. Ultrasound therapy For patients with implants or implanted electronic devices, only perform treatment after clarifying the absence of risk. The simultaneous connection of the patient to a high frequency surgical device is not permissible. This can cause burns. The operation of the ultrasound device in close proximity of strong electromagnetic fields (e.g. tomographs, X-ray or diathermia devices) may disturb the operation of the unit. Please maintain a safety distance of several meters. Handle the ultrasound transducer carefully; rough treatment can change its properties. Do not bring the ultrasound transducer in contact with sharp or pointed objects, as the aluminium transducer is sensitive to scratching. Clean the ultrasound transducer with commercially available detergents after use. The use of other coupling means other than SonoPlus from Zimmer MedizinSysteme can damage the ultrasound transducer. Vacuum For patients with a tendency for haematoma, only perform treatment once the absence of risk has been clarified. This unit is exclusively for use by medical specialists. This unit can induce functional faults or disturb the operation of devices in its close proximity. It may be necessary to take suitable precautions, such as repositioning, reconfiguration of the unit or shielding. 138

145 Technical Information General Operating voltage VacoP operating voltage Power consumption VacoP power consumption Protection class Mains fuse Application part Dimensions PhySys with Syscart PhySys Syscart Weight PhySys with Syscart and VacoP PhySys with Syscart without VacoP Syscart and VacoP PhySys Syscart VacoP Transport Operation Storage V / Hz 230 V / 50 Hz max. 150 VA max. 120 VA II 2 x 1.6 A T BF type H 138 x W 53 x L 52 cm H 30 x W 35 x L 20 cm H 109 x W 53 x L 52 cm 13.2 kg 11.2 kg 7.8 kg 5.4 kg 5.8 kg 2.2 kg in original packaging only +10 C to + 40 C, 30% 75% relative humidity, kpa -10 C to + 50 C, 10% 90% relative humidity, kpa 139

146 Technical Information Stimulation Current Delivered power (max.) up to 500 ohm Galvanisation (ma eff) 80 Diadynamic currents (ma eff) 20 High voltage currents (ma peak / ma eff) Medium frequency currents (ma peak / ma eff) Interference currents (ma peak / ma eff) Micro- currents (ma peak / ma eff) Low-frequency rectangular currents (ma peak / ma eff) 120 / / / / / 50 Accuracy < ± 30 % (This value represents the legally permissible value required by law, and not the actual accuracy for each unit) Note: Please note that with rising patient impedance, the delivered current intensities decrease. See the bar graph. 140

147 Technical Information Ultrasound US Transducers Frequency Small US transducer Maximum output Intensity stages Large US transducer Maximum output Intensity stages 0.8 and 2.4 MHz 1 cm², ERA = 0.93 cm² at 0.8 MHz, 0.64 cm² at 2.4 MHz 0.9 W at 0.8 MHz, 0.9 W at 2.4 MHz 0.1 to 1 W/cm² eff. in steps of 0.1 W/cm² 5 cm², ERA = 2.58 cm² at 0.8 MHz, 2.89 cm² at 2.4 MHz 7 W at 0.8 MHz, 8 W at 2.4 MHz 0.1 to 3 W/cm² eff. in steps of 0.1 W / cm² Accuracy < ± 20 % Ultrasound modes Replacement parts 1. Continuous 2. Pulsed, adjustable pulse frequencies 20 Hz, 50 Hz, 100 Hz Pulse duty factor 1:10...9:10 US Transducers are factory-calibrated and can be easily replaced. 141

148 Technical Information Vacuum Negative pressure Pulse mode kpa Period duration adjustable from 1 to 8 s in steps of 0.5 seconds, Pulse duty factor 1 : 1 Accuracy < ± 20 % 142

149 Cleaning Disinfection 27. Housing Clean housing with standard alcohol-free plastic cleaner. Disinfect housing with standard alcohol-free disinfectant suitable for plastic. Display Clean display with standard alcohol-free plastic cleaner. Disinfect housing with standard alcohol-free disinfectant suitable for plastic. US Transducers Clean US transducers with tap water. Disinfect transducers with standard alcohol-free disinfectant suitable for plastic.! Do not use cleaning agents containing alcohol. 143

150 Electrode Handling 28. All electrodes customary in electrotherapy can be connected to PhySys by means of insulated cable clips. The well proven single-use electrodes are especially well suited. Single-use electrodes offer the advantage of simple, rapid, accurate and hygienic application. Apart from the single-use electrodes, plate and rubber electrodes are also available for applications over especially large surfaces. Sponge pockets prevent bare electrodes lying on the skin. The sponge pockets must be moistened well during treatment, at best with warmed tap water. Fastening by means of rubber bands or Velcro tapes. Please note that rubber electrodes can lose their conductivity rapidly in use with polarised currents. Introduce the electrodes into the sponge pockets fully and attach with slight pressure, until they lie perfectly on the body. The fastening tapes should not leave any furrows behind. Electrical connection just as for the single-use electrode - with the clips of the electrode cables. Fasten the clips to the plate electrodes inserted fully in the sponge pocket. After every treatment rinse out the sponge pockets well with water. Cleaning the sponges: - Thermal disinfection, laundering at 95 C. - Sterilization in the autoclave. Do not apply electrodes onto skin injuries. Even small cracks or fissures usually cause burning and the current intensity is incorrectly assessed by the patient. If this cannot be circumvented, use zinc ointment for covering. 144

151 Declaration of Conformity 29. This product bears the CE marking CE 0123 in accordance with EU Medical Devices Directive 93/42/EEC and meets the essential requirements of Annex I to this Directive. The product is rated as Class IIb according to Annex IX of the Directive. PhySys has been developed, manufactured and tested in accordance with the ISO quality management system. 145

152 Delivery Scope Accessories 30. Contents on delivery PhySys complete, consisting of: Electro-ultrasound unit, VacoP and Syscart 2 patient cables 1 pair electrode cables grey, incl. 1 black and 1 red alligator clip 1 pair electrode cables white, incl. 1 black and 1 red alligator clip 1 variable frequency US transducer 0.8 and 2.4 MHz, white, ø 28 mm 1 pair Vaco electrode tubes red, m long 1 pair Vaco electrode tubes black, 1.60 m long 2 pairs Vaco self-closing electrodes, ø 90 mm, with sponges 2 pairs Vaco self-closing electrodes, ø 60 mm, with sponges 1 accessory shelf for column 2 touch pens 1 mains cable angled Scope of supply PhySys desktop unit complete, consisting of: Electro ultrasound therapy unit 2 patient cables 1 pair electrode cables grey, incl. 1 black and 1 red alligator clip 1 pair electrode cables white, incl. 1 black and 1 red alligator clip 1 variable frequency US transducer 0,8 and 2.4 MHz, white, ø 28 mm 2 touch pens 1 mains cable angled 146

153 Delivery Scope Accessories 30. Contents on delivery PhySys SysCart 1 accessory tray 3 removable shelves Contents on delivery VacoP available as insertion unit in SysCart only 1 pair Vaco electrode tubes red, m long 1 pair Vaco electrode tubes black, 1.60 m long 2 pairs Vaco self-closing electrodes, ø 90 mm, with sponges 2 pairs Vaco self-closing electrodes, ø 60 mm, with sponges 147

154 Delivery Scope Accessories 30. Use device only with accessories that are verified as being technically safe. Accessories Art.No.* Swivel base Touch pen 117 Mains cable angled, 3 m Electro therapy 122 Patient cable pair electrode cables grey, incl. 1 black and 1 red alligator clip, 70 cm pair electrode cables white, incl. 1 black and 1 red alligator clip, 70 cm 127 Clip red 128 Clip black 21 Single-use electrodes 135 pairs small (1 pack) 22 Single-use electrodes 90 pairs medium (1 pack) 23 Single-use electrodes 45 pairs large (1 pack) 43 Plate electrode 9 x 12 cm made of pure tin 96 Iontophoresis sponge 212 Pack of membrane foil for iontophoresis Pack: 1000 pieces, 180 x 120 mm 44 Rubber electrode 50 x 50 mm, 1 pair 97 Sponge pocket for # 44, 1 pair 46 Rubber electrode 100 x 50 mm, 1 pair 98 Sponge pocket for # 46, 1 pair 232 Rubber band 60 cm gel., with button 233 Rubber band 120 cm gel., with button 230 Velcro strap 60 cm long, 10 cm wide 231 Velcro strap 120 cm long, 10 cm wide 148

155 Delivery Scope Accessories 30. Accessories Ultrasound therapy Art.No.* 1100XX Variable frequency US transducer 0.8 and 2.4 MHz, white, ø 28 mm 1500XX Variable frequency US transducer 0.8 and 2.4 MHz, grey, ø 13 mm US transducer holder made of Plexiglas 6 Sono plus gel 1 bottle VacoP 95 Viscose sponge large for # Viscose sponge small, for # Vaco electrode, ø 90 mm, self-closing 71 Vaco electrode, ø 60 mm, self-closing 164 Vaco electrode tube, red, 1.60 m long 165 Vaco electrode tube, black, 1.60 m long Column Syscart Accessories tray Shelf above Shelf middle Shelf below Castor, 75 mm Castor, 75 mm with brake Rights reserved to make changes. 149

156 Device Combinations 31. PhySys can be combined with VacoP. The party that combines and uses the devices as a medical system is responsible for the correct assembly of the devices. 150

157 Safety and Maintenance 32. PhySys is manufactured according to the safety regulations EN (VDE 0750 Part 1). Zimmer MedizinSysteme can consider itself responsible as manufacturer for safety and reliability only - if the unit is operated at a socket with protective contact according to the regulations and the electrical installation corresponds to DIN VDE 0100 Part if the unit is operated in agreement with the Instructions for Use, PhySys - if extensions, readjustments or changes are performed only by persons who are authorized by Zimmer MedizinSysteme. - The user has to convince himself about the functional safety and correct condition before use of the unit. - Before every use check the US transducer, the cable and the connectors for damage that could impair the safety of the unit (e.g. cracks). - The unit may be operated only by correspondingly trained personnel. - Immediately disconnect the unit from the power supply if liquids penetrate into it. The unit contains no parts that can be maintained by the operator. 151

158 Automatic Functional Test 33. PhySys runs a self-test that checks all internal components automatically after it is switched on. An error message is shown in case of faults. An extended function test can also be run as follows in all three operating modes. These tests should be run once a month or if there is any doubt about the operational reliability of the device. Stimulation current Ultrasound Vacuum Select program GA 00. Short-circuit patient cable. The display in the bar graph must be completely full at maximum intensity. Run the test consecutively with both channels. Select transducer and cover the transducer with gel. The coupling display must show over 90% at low power and at the start of therapy. Run the test consecutively using both transducers. Then clean transducers. Select vacuum and establish start vacuum. Short-circuit Vaco electrodes and set maximum vacuum. The bar graph must be completely full in continuous mode. 152

159 Safety Checks 34. Please observe any national regulations for recurrent checks. General information Store Instructions for Use, PhySys manual so that it is accessible to operators of the device at all times. Access must be available for inspection authorities at any time. 153

160 Error Messages Troubleshooting Disposal 35. Cable check Means in stimulation current therapy in the constant current mode: Interruption of the patient circuit. As a rule this message indicates electrodes dropped off, dirty electrode terminals, defective patient cable or a defective patient fuse. Delete the message by pressing OK key. Excess current This is understood to mean an increase over the maximum permissible current. Excessive current in the constant mode indicates, as a rule, a defect in the unit, whereas excessive current in the constant voltage mode can occur due to change of the patient s resistance (e.g. moist skin). Delete the message by pressing OK key. If the error message appears again, please notify customer service. 154

161 Error Messages Troubleshooting Disposal 35. VacoP If VacoP does not reach the specified set vacuum, there may be a leak in the system. Check that the Vaco electrodes are correctly applied to the patient. Check also that the drainage valve has been closed after drainage. Important! After closing, the drainage valve must be at 90 to the direction of flow. 155

162 Error Messages Troubleshooting Disposal 35. Error The display 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 is reached through your sales representative or by contacting the headquarters in Neu-Ulm, Germany. Headquarters Zimmer MedizinSysteme GmbH Junkersstraße 9 D Neu-Ulm Tel Fax export@zimmer.de Disposal The device must be disposed of by an approved disposal company and must not be discarded with household or special waste. 156