Bedienung Soleo Galva SonoStim GB · Paralysis diagnostics and therapy overview 90 19.1 Lange medium frequency test 91 19.2 ... The compact design saves room in the practice and is

Operating Instructions

Soleoline

Soleo SonoStim, Soleo Galva, Soleo VacoS

GB

Soleo SonoStim / Soleo Galva Front view of device

Fig. 1

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. 2

Screen readouts

8 Status bar 10 Title bar 9 Navigation bar 11 Buttons on the screen

1 2

3

4

5

4

7

10

9 11

8

3

6

Fig. 3

Soleo SonoStim / Soleo Galva Rear view of device

Switch and connector sockets

12 Connector for mains cable 16 Socket for electrode cable channel II 13 Fuse drawer for mains fuse 17 Socket for 0.8/2.4 MHz ultrasound head 14 On/off switch 18 Socket for electrode cable channel I 15 Socket without function in Soleoline

12

13

15

14

16 17 18

VacoS Front view of device

Fig. 4

Connector sockets

Circuit I 1 Connector socket Vaco electrode sleeve, black, cathode 2 Connector socket Vaco electrode sleeve, red, anode Circuit II 3 Connector socket Vaco electrode sleeve, black, cathode 4 Connector socket Vaco electrode sleeve, red, anode

1

2 4

3

VacoS Rear view of device

Fig. 5


5 On/off switch 9 Socket for electrode cable Channel II 6 Connector for mains connector cable 10 Socket for connecting cable with

SonoStim I Galva channel II 7 Connector for mains cable 11 Socket for electrode cable channel I 8 Fuse holder for mains fuse 12 Socket for connecting cable with

SonoStim I Galva channel I

5

6

7 8 9 10 11 12

Soleo SonoStim/Soleo Galva and VacoS

Side view Fig. 6

13 Connector valve for water separator

13

Contents

Soleo SonoStim / Soleo Galva

Front view of device Selection and control elements/screen readouts

Rear view of device


VacoS Front view of device Connector sockets Rear view of device Switch and connector sockets

Soleo SonoStim / Soleo Galva and VacoS Side view

Page

1. Soleoline – Summary 1

2. Fitting the cables, starting the system 2.1 Soleo SonoStim / Soleo Galva 2 2.2 VacoS 3

3. Configuration 3.1 General 6 3.2 Electrotherapy 12 3.3 Ultrasound therapy 14 3.4 Maintenance 16

4. Soleo SonoStim – Quick operating instructions 4.1 Electrotherapy 17 4.2 Ultrasound therapy 21 4.2.1 Water bath treatment 25 4.3 Combination therapy 27

5. Soleo Galva – Quick operating instructions 31

6. Soleo SonoStim / Soleo Galva Quick operating instructions for electrotherapy with VacoS

32

7. General instructions – VacoS/SD card 36

Contents

8. Description of the selection buttons 37

9. Electrotherapy – Screenshots of the various therapy screens 43

10. Electrotherapy 10.1 Description of the screen elements 45 10.2 Description of the parameter button 47 10.3 Description of the surge button 49 10.4 Change current form parameters 51 10.5 Change surge parameters 55 10.6 Description of the screen elements and the interference button 58

11. Ultrasound therapy – Screenshot of the therapy screen 59

12. Ultrasound therapy 12.1 Description of screen elements 60 12.2 Description of the parameter button 63 12.3 Description of the treatment depth button 66

13. Combination therapy – Screenshot of the therapy screen 67

14. Electrotherapy with VacoS – Screenshot of the therapy screen 68 14.1 Description of the screen elements 69 14.2 Changing parameters 70

15. Indications menu 73

16. Saving a modified programme 76 16.1 Favourites 78 16.2 Memory 79

17. Retrieving and editing favourites and memory 17.1 Retrieving favourites 80 17.2 Editing favourites 81 17.3 Retrieving and editing memory 83

18. Sequence programmes 84

19. Paralysis diagnostics and therapy overview 90 19.1 Lange medium frequency test 91 19.2 Neofaradic test 92 19.3 Chronaxia/accommodation quotient 93 19.4 Fischgold test 97

Contents

20. Indications 99

21. Contraindications 103

22. Explanation of symbols 105

23. Warnings 106

24. General technical information Soleo SonoStim / Soleo Galva

108

25. General technical information – VacoS 109

26. Specific technical Information 26.1 Stimulation current 110 26.2 Ultrasound 111 26.3 VacoS 112

27. Cleaning, disinfection 113

28. Electrodes 28.1 Use and care 114 28.2 Information about the use of various electrode types 115

29. CE Marking 117

30. Contents on delivery, accessories 30.1 Soleo SonoStim 118 30.2 Soleo Galva 119 30.3 VacoS 120

31. Device combinations 121

32. Safety and maintenance 122

33. Functional test 123

34. Safety checks 124

35. Error messages, Troubleshooting, Disposal 125

36. Manufacturer's EMC declaration 130

Valid for Soleo SonoStim, Soleo Galva and VacoS devices.

These Operating 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 05.01.2010.

1

Soleoline – Summary

1

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 with the option of attaching a vacuum unit. Soleo Galva An ultramodern and innovative electrotherapy device with the option of attaching a vacuum unit. Soleo Sono An ultramodern and innovative ultrasound therapy device.

Note: The operation of Soleo Sono is described in a separate set of instructions. What does the Soleoline do?

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.

What are the advantages of Soleoline?

A clear contemporary colour screen showing all parameters necessary for therapy as well as modern touch control. Individual programme start configuration and clear, simple menu navigation make operation of the device easy and comfortable for users.

The combination of electrotherapy and ultrasound therapy in a single system enables the use of the established combination therapy.

The compact design saves room in the practice and is highly suited for use in home visits.

The use of the vacuum unit ensures comfortable electrode application and also provides a pleasant massage effect for patients.

Innovations in Soleoline?

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.

Note: The device should only be used by medical specialists (e.g. doctors, therapists

and health paraprofessionals).

2

Fitting the cables Starting the system 2.1 Soleo SonoStim / Soleo Galva

2

Note: The following description of fitting the cables refers to the operation of Soleo

SonoStim / Soleo Galva without VacoS.

Note: There are green arrows on the cables as guides for correct connection with the

device.

Electrotherapy 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

Plug the mains cable into the appropriate socket (12) on the device and then plug into the mains socket.

Switching on the device

Switch on the device using the rocker switch (14).

Note: All buttons, menus and submenus are activated directly on the screen by

touching it or using the touch pen.

3

Fitting the cables Starting the system 2.2 VacoS

2

Note: VacoS is controlled and operated via Soleo SonoStim/Soleo Galva. Stand-

alone operation is not possible.

Preparation Place Soleo SonoStim / Soleo Galva on VacoS so that the devices are flush on

top of one another. The connector sockets for the Vaco electrode sleeves must be at the front of the device (Fig. 4).

Connecting VacoS with SonoStim / Galva

When fitting the connection cable ensure that the green arrow is pointing downwards when connecting the cable to Soleo SonoStim / Soleo Galva (18). When fitting the connection cable ensure that the green arrow is pointing upwards when connecting the cable to VacoS (12). Channel I Plug the connecting cable into the appropriate sockets on Soleo SonoStim / Soleo Galva (18) and on VacoS (12).

Channel II Plug the connecting cable into the appropriate sockets on Soleo SonoStim / Soleo Galva (16) and on VacoS (10).

4


2

Note: If Soleo SonoStim / Soleo Galva is operated in connection with VacoS, the

electrode cable is connected to VacoS. The installation is described below. Fitting the electrode cable

Ensure when connecting the electrode cable to VacoS that the green arrow is pointing upwards when being plugged in.

Plug the electrode cable for channel I into the appropriate socket (11) on

VacoS. Plug the electrode cable for channel II into the appropriate socket (9) on VacoS. Attach the red alligator clip to the red connector on the electrode cable. Attach the black alligator clip to the black connector on the electrode cable.

Installation of Vaco electrode sleeves

Plug the black Vaco electrode sleeve into the appropriate socket (1) on the front of VacoS here:

I - Plug the red Vaco electrode sleeve into the appropriate socket (2) on the front of VacoS here:

I + Plug the black Vaco electrode sleeve into the appropriate socket (3) on the front of VacoS here:

II - Plug the red Vaco electrode sleeve into the appropriate socket (4) on the front of VacoS here:

II + Plug the Vaco electrodes with the connector on the free end of the Vaco electrode sleeves.

5


2

Fitting the Vaco electrodes

Connect a Vaco electrode to each of the 4 Vaco electrode sleeves.

Connecting to the mains

Plug the short mains connecting cable into the appropriate sockets on VacoS (6) and Soleo SonoStim / Soleo Galva (12).

Connecting the mains cable

Plug the mains cable into the appropriate socket on VacoS (7) and then plug the cable into the mains power wall socket.

Switching on VacoS Switch on VacoS using the rocker switch (5).

Note: Press this icon to activate VacoS.

The window is only active if VacoS is switched on and the devices are connected to one another as described.

6

Configuration 3.1 General

3

Note: The following descriptions always refer to therapy using a single channel and

are based on the factory default settings.

Note: Changes to the default settings can only be made from the start screen.

Start screen After switching on the device and the self-test, the start screen opens.

Selecting configuration

Press the button to open the configuration menu.

7


3

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 arrow key to open the

drop-down menu to select the language.

The language is selected by pressing on the appropriate row.

8


3

Start settings Configuration options for the programme start settings:

Press the arrow key to open the drop-down menu to select the programme start configurations.

The options are selected by pressing on the appropriate row.

Start screen Option to choose between 2 start screens:

Press the arrow key to open the drop-down menu to select the start screen.

The start screen is selected by pressing on the appropriate row.

9


3

Sound To switch the signal sound on and off when activating the control fields:

Press the arrow key to open the drop-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 arrow key to open the window to adjust the volume. The volume is adjusted using both arrow keys.

Brightness Option to adjust the screen brightness in steps from 0 to 10:

The brightness is adjusted using both arrow keys.

10


3

Screen saver Option to configure the start of the screen saver after 0 to 20 minutes:

The time is selected using both arrow keys.

Note: While therapy is running the screen saver function is deactivated.

Welcome message Option to configure an individual welcome message.

Activate the Welcome message field

to open the screen keyboard to enter a welcome message.

11


3

Setting defaults

Press the button to reset the factory standard settings.

Version

Press the button to open the window with information about the current software version.

Press the OK button to close the window.

12

Configuration 3.2 Electrotherapy

3

Electrotherapy settings

Activate the menu

to open the ‘Electrostimulation 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

programmes.


Polarity cycle Option to adjust the polarity reversal time from 10 to 120 seconds.


13

Configuration

3.2 Electrotherapy

3

Frequency Option to adjust the base frequency to 2500 Hz, 4000 Hz and 8000 Hz:

The frequency is selected using both arrow keys.

Note: The device is preset with a base frequency of 8000 Hz. If you modify the base

frequency in this menu, the name of programmes MF00 to MF11 will remain with 8000Hz. The programmes themselves will work with the frequency selected in this menu.

14

Configuration 3.3 Ultrasound therapy

3

Note: Activation of the ‘Ultrasound Therapy’ menu and the associated settings is

only possible in the Soleo SonoStim version.

Ultrasound therapy settings

Press the menu

to open the ‘Ultrasound therapy configuration’ screen.

The settings required for therapy can be adjusted here.

Coupling signal Option to adjust (50 to 95%) the threshold for coupling:

The threshold is adjusted using both arrow keys.

15

Configuration 3.3 Ultrasound therapy

3

Units Option to configure the units for intensity in a bar graph:

Press the arrow

button to open the drop-down menu to select the desired units for power.

The unit is selected by pressing on the appropriate row.

16

Configuration

3.4 Maintenance

3

Updates

Activate the menu

/ to open the ‘Maintenance’ screen.

The maintenance programmes 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 technicians or technicians trained by Zimmer MedizinSysteme only.

17

Soleo SonoStim Quick operating instructions 4.1 Electrostimulation

4

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 programme

Press the button to open the ‘Programme’ screen. The programme is selected here.

SonoStim programme

There are 3 different programmes available in SonoStim. - Electrotherapy - Ultrasound therapy - Combination therapy

18

Soleo SonoStim Quick operating instructions 4.1 Electrotherapy

4

Selecting electrotherapy

Electrotherapy is selected by pressing on the appropriate row.

The following description refers to the electrotherapy programme.

Selecting current forms group

Select the current forms group by pressing on the appropriate row (here monophasic rectangular current).

19

Soleo SonoStim Quick operating instructions 4.1 Electrotherapy

4

Selecting current form

Select the current form by pressing on the appropriate row (here LF 00).

Therapy screen After selecting the current form, the therapy screen opens automatically for

channel I.

20

Soleo SonoStim Quick operating instructions

4.1 Electrotherapy

4

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.

Note:

The Vacuum icon is only visible if VacoS is connected to Soleo SonoStim / Soleo Galva and switched on as described in Chapter 2.2.

21

Soleo SonoStim Quick operating instructions 4.2 Ultrasound therapy

4



Selecting ultrasound therapy

Ultrasound therapy is selected by pressing on the appropriate row.

22


4

Selecting the programme

Select the desired ultrasound therapy programme by pressing on the appropriate row (here US 01).

Therapy screen After selecting the ultrasound therapy programme, the therapy screen opens.

Note: Check that the information shown on the Parameter button (here 5 cm2)

matches the ultrasound head connected before starting therapy.

23

Soleo SonoStim Quick operating instructions 4.2. Ultrasound therapy

4

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 dose set is shown in the bar graph and the therapy time counts down in seconds. The coupling display is active.

24


4

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.

25

Soleo SonoStim Quick operating instructions 4.2.1 Water bath treatment

4

Note:

If the ultrasound therapy is done in a water bath, the ultrasound head temperature monitoring must be changed before starting the therapy.

Implementation

Press the ‘Parameters’

button to open the ‘Ultrasound Parameters’ window.

Pressing ‘Water bath’ button

By pressing the ‘Water bath’

button and confirming with OK, the ultrasound head temperature monitoring is modified for therapy in a water bath.

26

Soleo SonoStim Quick operating instructions 4.2.1 Water bath treatment

4

If at the end of the therapy an additional treatment with the same ultrasound programme will be carried out, after adjusting the intensity, the following message appears:

If, at the end of therapy, the programme will be changed, the function of the water bath button is automatically deactivated.

Continuing therapy in the water bath

Press the button

Ending therapy in the water bath

Press the button

Note: Once therapy in the water bath is complete, the temperature of the ultrasound

head may be too high for treatment outside the water bath. This is shown in the status bar by the message ‘Ultrasound head temperature adjustment’. The ultrasound head cannot be used while this is happening. Once the temperature adjustment of the ultrasound head is complete, the message disappears and the therapy can be continued.

27

Soleo SonoStim Quick operating instructions 4.3 Combination therapy

4



Selecting combination therapy

Select combination therapy by pressing on the appropriate row.

28


4


Select the desired combination therapy programme by pressing on the appropriate row.

Therapy screen After selecting the combined therapy programme, the therapy screen opens.

29


4

Setting intensity of the ultrasound

Adjust the intensity using the intensity controller on the left.

Starting therapy Combination 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 combination therapy, always ensure that the conducting electrode

cable (anode) is only active on channel I. The second electrode is then the ultrasound head.

30


4

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.

31

Soleo Galva Quick operating instructions

5


Press the button to open the ‘Programme’ screen.

Selecting current forms group

Select the current forms group by pressing on the appropriate row (here monophasic rectangular current).

Note: The additional steps required to carry out the therapy are described in more detail in Section 4.1.

32

Soleo SonoStim / Soleo Galva Quick operating instructions Electrotherapy with VacoS

6

Note: Up to the therapy screen, the procedure is analogous to that described in

Section 4.1 Electrotherapy.

Note: If a vacuum unit is not attached, the ‘Vacuum’ button is not displayed.

This is also the case if data transmission or the connection of the vacuum unit to Soleo SonoStim / Soleo Galva is broken or interrupted.

Opening the Vacuum menu

Press the

button to open the Vacuum menu.

33


6

Activating base vacuum

A base vacuum of 16 kPa is set at the factory.

Press the button to activate the base vacuum for intake of the Vaco electrodes.

By activating the base vacuum, the vacuum is active. In the bar graph the value of the base vacuum is shown.

Note: The factory setting is continuous mode.

Press the ‘Mode’ button to open the input window ‘Vacuum’ to set the pulsed operating mode. A detailed description can be found in Section 14.2.

Selecting vacuum

Set the intensity of the vacuum using both the arrow keys.

In the bar graph the current value of the vacuum is now shown.

34


6

Starting electrotherapy

By adjusting the intensity using the intensity controller on the left, the display in the lower status bar changes from ‘Ready’ to ‘Active’ and the therapy starts. The effective current is shown in the bar graph and the therapy time counts down in seconds.

Ending electrotherapy

At the end of the therapy time, an acoustic signal indicates that the therapy has ended, the clock is reset to 00:00, the intensity automatically returns to zero and the bar graph display disappears. The display in the bottom status bar changes from ‘Active’ to ‘Ready’. The therapy time is automatically reset at the end of the therapy.

35


6

Note: The vacuum must be ended manually using ‘Stop’ after expiry of the time.

The ‘Stop’ button changes to ‘Start’.

Deactivating the vacuum

Deactivate the vacuum using the button.

36

General information VacoS SD card

7

VacoS Note:

VacoS contains an integrated water separator that collects the moisture collected in the sponges and protects the vacuum unit from limescale. If the water separator is full, the message ‘Empty water separator’ appears on the screen.

If the water separator is not emptied, therapy cannot be started. Empty the water separator as described in Section 35.

SD card User-defined settings and the indications list are saved on the SD card.

Note: If the SD card is not inserted, the message ‘No SD card found’ appears when

the Indications, Favourites and Memory buttons are pressed. Deactivate the message as described in Section 35.

37

Description of the selection buttons

8

Note: The following descriptions are all based on the factory settings.

Configuration

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.

Favourites

Press the button • to open Favourites for editing • to add the programme to Favourites in memory mode.

Programmes

Press the button to open the Programmes window.

38


8

Indications

Press the button to open the indications menu.

Memory

Press the button • to open the memory list for editing • to add the programme 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.

39


8

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. Alternate activation: The current forms are started and stopped simultaneously on both channels. The surges are alternate.

Parallel activation: The current forms are started and stopped simultaneously on both channels. The surges are simultaneous.

Separate activation: The current forms are started and stopped separately on both channels. The surges are independent of one another. Can only be activated in Duostim mode.

40


8

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: Both buttons are highlighted in channel mode and can only be activated in

Duostim mode.

Saving

Press the button to open the screen to save a programme. The ‘Save’ button can only be pressed from the therapy screen.

Back

Press the button to go back one screen.

Editing

Press the button • to open the ‘Memory’ screen to edit the memory list • to open the ‘Favourites’ screen to edit Favourites

41


8

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 to delete the selected programme from the list.

Scrolling forwards

Press the button to scroll one page down the list.

Scrolling backwards

Press the button to scroll one page up the list.

42


8

Close

Press the button to close the Favourites and Memory programmes.

Cancel

Press the button to reject the changes made.

OK

Press the button to confirm the changes in the selected list.

OK

The changes are applied by pressing the button.

43

Electrotherapy Screenshots of the various therapy screens

9

Monostim

Example: Programme LF00 on one channel (I).

Twinstim

Example: Programme LF00 on both channels (I and II).

44

Electrotherapy Screenshots of the various therapy screens

9

Duostim alternating

Duostim parallel

Duostim separate

45

Electrotherapy

10.1 Description of the screen elements

10

Note: The ‘Parameter’, ‘Surge’ and ‘Vacuum’ buttons turn into control panels once

an electrotherapy programme 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 pulse pause) are changed, the

effects of the current form may also change. The window is therefore no longer visible after a change.

46

Electrotherapy

10.1 Description of the screen elements

10

Therapy time

Shows the total therapy time from the start of therapy.

After starting therapy the remaining time is displayed.

Bar graph of intensity

Shows the currently specified intensity. In CC mode:

display in mA eff or peak. In CV mode:

display in V peak.

Vacuum

1 Indicates on the therapy screen that the vacuum unit is connected .

2 Opens after activation of the vacuum settings and start screen. The

parameters can be set and the vacuum unit started here.

Note: If a vacuum unit is not connected, this button is not visible.

47

Electrotherapy

10.2 Description of the parameters button

10

Parameters

1. Presents the parameters of the current therapy programme. 2. Activates ‘ Parameters of Current Form’ for modification. A detailed description can be found in Section 10.4. 1.1 Frequency display 1.2 Graphic view of waveform 1.3 Polarity 1.4 CC / CV 1.5 Galvanic component

Note: Modes 1.3–1.5 cannot be used with all current forms and are therefore not

always displayed.

1.1 Frequency display The frequency modes are shown differently depending on the current form,

e.g.: • single frequency (base frequency)

• variable frequency

Two frequencies with an animated display of the current intermediate frequency as a bar.

48

Electrotherapy

10.2 Description of the parameters button

10

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

Electrotherapy

10.3 Description of the surge button

10

Surge active

Indicates that a surge is activated and shows the parameters of the effective surge.

6.0 / 12.0 s 6.0 - rise time and retention time of the surge phase in seconds 12.0 - pause of the surge phase in seconds

After activation of the surge window, the surge parameters can be set separately. For a detailed description see Section 10.5.

Note: If the Surge icon is activated during therapy, the therapy will be interrupted and the intensity will be set to zero. The therapy time is stopped. The therapy is restarted for the remaining time by adjusting the intensity.

Surge deactivated

When the surge is deactivated, the surge window is shown in minimised form.

After activation of the surge window, the surge can be activated and the surge parameters can be set separately. For a detailed description see Section 10.5.

Note: If there is no factory setting for a surge in a programme, this window is not shown.

50

Electrotherapy

10.3 Description of the surge button

10

Surge inactive

When the therapy is inactive, the surge is shown completely in blue.

Surge active

During therapy, the surge is shown as an animation showing the surge position.

Synchronisation mode alternated

Alternating

In two-channel mode the alternating surge mode is shown by the two opposing arrows in the top left corner.

Synchronisation mode parallel

Parallel

In two-channel mode the parallel surge mode is shown by the two parallel arrows in the top left corner.

51

Electrotherapy

10.4 Change current form parameters

10

Note: Only the parameters that are shown in the parameter window can be

changed. Note: 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

Electrotherapy


10

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: Changes to the pulse and pulse hold time also change the frequency.

Changing parameters

Use the arrow keys

to increase or decrease the value within the limits specified in the current form definition.

53

Electrotherapy


10

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

Electrotherapy 10.4 Change current form parameters

10

Saving parameters

Press the

button to save the modified parameters.

Cancelling changes

Press the

button to reject changes.

55

Electrotherapy 10.5 Change surge parameters

10

Note: If the Surge 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 Surge button

When the Surge button is activated, the ‘Surge Parameters’ window is opened.

Surge parameters

The surge parameters can be modified as follows by the user:

Surge rise time: 0 s: surge off Shortest rise time: 0.5 s Longest rise time: 60 s Shortest hold time: 0 s Longest hold time: 60 s Shortest fall time: 0.2 s Longest fall time: 5 s Shortest pause time: 0.2 s Longest pause time: 60 s

56


10

The duration of the surge phase is calculated from the duration of the rise time, hold time and down time.

Selecting parameters

Select the parameters to be changed using the

arrow keys. 1. Rise time (1.5 s here) 2. Hold time (4.0 s here) 3. Pause time (12 s here)

The parameter highlighted in blue can be changed (rise time here).

Changing parameters

Use the

arrow keys to increase or decrease the value within the limits specified in the surge parameters definition.

57


10

Saving parameters

Press the


Cancelling changes

Press the

button to reject changes.

58

Electrotherapy

10.6 Description of the screen elements and the interference button

10

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

Ultrasound therapy Screenshot of the therapy screen

11

60

Ultrasound therapy 12.1 Description of the screen elements

12

Title bar

The title bar shows the channel mode and the name of the current ultrasound therapy programme.

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 programme parameters.

2. Opens the ‘Parameters’ window.

A detailed description can be found in Section 12.2. 1.1 Ultrasound head and size of ultrasound head 1.2 Operating mode / pulse frequency / pulse ratio

61

Ultrasound therapy 12.1 Description of the screen

elements

12

1.1 Ultrasound head Graphic view of the active ultrasound head (large ultrasound head here).

1.2 Operating mode

Pulse ratio Pulse frequency

Graphic view of the operating mode continuous

or pulsed

Pulsed operating mode showing the pulse ratio (1:3 here) and the pulse frequency (50 Hz here).

Depth effect The bar graph shows the current frequency ratio of 0.8 MHz (800 kHz) to 2.4

MHz as a percentage. In this example: 75% 2.4 MHz 25% 0.8 MHz (800 kHz)

62

Ultrasound therapy 12.1 Description of the screen

elements

12

Coupling Important:

The coupling is shown digitally as a percentage.

The most beneficial coupling value is 100%. If the coupling is below the preset value (factory setting 75%), an acoustic signal sounds and the therapy time is paused. In this case: Set a new coupling value and when the coupling is sufficient the therapy will continue.

Bar graph

Shows the currently specified intensity.

63

Ultrasound therapy 12.2 Description of the parameter

button

12

Note:

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.

Note: Only the parameters that are shown in the parameter window can be

changed.

Activating the parameter button

When the ‘Parameter’ window is activated, the ‘Ultrasound Parameters’ window is opened.

Ultrasound parameters

The ultrasound mode can be selected here and the ultrasound head can be switched to therapy in a water bath.

64


button

12

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

Selecting the frequency

Press the two arrow buttons

to select the desired frequency. Frequencies: 20 Hz, 50 Hz and 100 Hz.

Water bath Press the

button to switch the ultrasound head temperature monitoring to therapy in a water bath.

65


button

12

Saving Press the


Cancelling changes

Press the

button to reject changes made.

66

Ultrasound therapy 12.3 Description of the treatment

depth button

12

Note:

If the Treatment Depth 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.

Adjusting treatment depth

Press the ‘Depth of treatment’ button

to open the treatment depth screen.

Adjust the frequency ratios 0.8 MHz to 2.4 MHz using both arrow keys.

67

Combination therapy Screenshot of the therapy screen

13.

Note: The buttons and functions on the ‘Combination’ therapy screen correspond

exactly to the therapy screens for ‘Electrostimulation’ and ‘Ultrasound therapy’ as described in the previous sections. An extensive description of the therapy screen will not be given here.

68

Electrotherapy with VacoS Screenshot of the therapy screen

14

Note: The ‘Electrotherapy’ displays and buttons have been described in detail in the

preceding sections and only the displays and buttons that are also active when using VacoS will be described in this section.

Electrotherapy combined with VacoS

Note: The Vacuum button can only be activated from the therapy screen of a

programme in the Electrotherapy group.

69

Electrotherapy with VacoS 14.1 Description of the screen

elements

14

Vacuum

Signals the connection of the vacuum unit in the therapy screen.

Note: If a vacuum unit is not attached, the ‘Vacuum’ button is not displayed.

This is also the case if data transmission or the connection of the vacuum unit to SonoStim / Soleo Galva is broken or interrupted.

Parameters The display shows the parameters of the factory settings.

1. View of base vacuum as bar graph

2. Operating mode (continuous here)

3. Numeric display of base vacuum

Activation of the base vacuum

The bars in the bar graph show the activation of the base vacuum.

70

Electrotherapy with VacoS

14.2 Changing parameters

14

Changing vacuum parameters

Press the button

to open the vacuum menu to set the vacuum parameters.

Continuous mode

The factory setting is continuous mode.

Pulse mode

Adjust the pulse duration using both arrow keys. The pulse time can be set from 0.5 s to 8.0 s.

71

Electrotherapy with VacoS 14.2 Changing parameters

14

Changing base vacuum

Increase or decrease the base vacuum using the arrow keys to the left and right of the ‘Base Vacuum’ window.

Note: If the base vacuum is set higher than 16 kPa, the vacuum must be increased

first. An increase in the base vacuum above 16 kPa is then possible.

Vacuum

Adjust the vacuum using both arrow keys next to the ‘Vacuum’ window.

72

Electrotherapy with VacoS 14.2 Changing parameters

14

Saving parameters

Press the button

to save the changed parameters and to return to the ‘Vacuum’ start screen.

Cancelling changes

Press the button

to reject the changes and to return to the ‘Vacuum’ start screen.

73

Indications menu

15

The Indications menu helps you to select the therapy. Indications

Press the button

to open the Indications menu.

Selecting by body region

Select a body region by touching a blue circle.

74

Indications menu

15

Selecting by symptoms

After selecting the desired body region (shoulder in this example) the Indication window opens showing various symptoms in the shoulder region. Select the symptoms by clicking on the relevant row (shoulder-arm syndrome in this example).

Selecting by detailed symptoms

After selecting the symptoms another window opens showing detailed symptoms. Select the detailed symptoms by clicking on the relevant row (subacute pain status in this example).

75

Indications menu

15

Therapy information After selecting the detailed symptoms another window opens showing

detailed therapy information and a suggested programme.

Selecting the therapy programme

Press the button

to open the therapy screen with the programme.

76

Saving a modified programme

16

As described in the previous sections, the programme parameters can be

separately modified and saved. Note: The procedure for saving is similar for all therapy forms. The save procedure

for an electrotherapy programme is described below. Selecting the programme

Changing the parameters

The change is shown in the title bar (LF 01 – modified).

77

Saving a modified programme

16

Opening the memory list

Press the button

to open the screen to enter the programme name.

Naming the programme

Two options are available for naming a programme.

1. Accept the programme name in the input field. 2. Enter a custom programme name. If using a custom name, use the

keyboard to enter the programme name.

Note: When entering a custom programme name, the name in the input field must first be deleted.

78

Saving a modified programme 16.1 Favourites

16

Saving a programme in Favourites Press the button to open Favourites.

Adding the programme to Favourites

Press the button to add the programme to Favourites.

The programme is automatically saved in the first free space in the list. F: Favourites 00: Programme number in the list

79

Saving a modified programme 16.2 Memory

16

Saving a programme in the Memory Press the button to open the Memory.

Adding the programme to the Memory

Press the button to add the program to the Memory.

The programme is automatically saved in the first free space in the list. S: Memory 00: Programme number in the list

80

Retrieving and editing favourites and memory 17.1 Retrieving favourites

17

The individual saved programmes are listed in Favourites.

From here they can be: 1. retrieved for therapy or 2. edited (sequence changed or deleted).

Selecting Favourites

Press the

button to open Favourites.

Selecting therapy Select the desired programme by pressing on the appropriate row.

81

Retrieving and editing favourites and memory 17.2 Editing favourites

17

Editing Favourites

Press the

button to open the ‘Edit Favourites’ screen.


Select the program to be edited by clicking on the appropriate row.

Changing sequence Activate the appropriate arrow keys to move the programme up or down in

the sequence.

82

Retrieving and editing favourites and memory 17.2 Editing favourites

17

Deleting a programme

Pressing the

button triggers the security question ‘Delete’.

Press the button to delete the saved program.

Press the button to keep the saved program.

83

Retrieving and editing favourites and memory 17.3 Retrieving and editing memory

17

Selecting Memory

Press the

button to open the Memory.

Selecting therapy Select the desired programme by pressing on the appropriate row. Editing Memory Note:

The following steps to edit the Memory correspond exactly to those used to edit Favourites that were described in detail in the preceding section.

84

Sequence programmes

18

Sequence programmes are a compilation of up to three electrotherapy

programs that can be automatically started in sequence. Various programmes are factory-defined in the ‘Currents’ programmes for sports rehabilitation. They generally consist of warm-up, training and relaxation phases.

Therapy screen for a preset programme

Sequence display

The currently active sequence (1 to 3)

is shown in a field.

Therapy time

A therapy time is specified for all three phases. The top number shows the remaining time for the current phase. The bottom number shows the total remaining time.

85

Sequence programmes

18

Note: Because different pulse shapes and frequencies entail different sensitivities

to current, the intensity surges are defined for the individual sequences before starting the therapy.

Activating the sequence window

Press the field

to open the ‘Sequences’ window.

Before starting the sequence therapy, the intensity surges are defined here for the individual sequences.

Defining intensities Sequence 1 Warm-up phase

Sequence 1 is highlighted in blue and is active. Confirm sequence 1 with OK. Define the intensity for sequence 1 using the two intensity buttons.

86

Sequence programmes

18

Sequence 2 General muscle strengthening

Press the field


Select sequence 2 by clicking on the row. It is highlighted in blue after activation. Confirm sequence 2 with OK. Define the intensity for sequence 2 using the two intensity buttons.

87

Sequence programmes

18

Sequence 1 Relaxation phase

Press the field


Select sequence 3 by clicking on the row. It is highlighted in blue after activation. Confirm sequence 3 with OK. Define the intensity for sequence 3 using the two intensity buttons.

Note: After defining the intensities, the therapy time runs through the various sequences. When the next sequence is selected, the predefined intensity of the previous sequence is automatically saved.

88

Sequence programmes

18

Activating sequence 1

Press the field


Activate sequence 1 by directly pressing on the row and confirm with OK.

By activating sequence 1, the therapy time is reset to the predefined value

and the start button becomes active.

89

Sequence programmes

18

Starting therapy

Click the button to start the therapy.

The three sequences run in succession. The change of sequence is indicated by an acoustic signal.

Ending therapy When the therapy time has finished an acoustic signal sounds.

90

Paralysis diagnostics and therapy overview

19

Soleo SonoStim / Soleo Galva include special programmes for diagnostics

and therapy of paresis and flaccid paralysis. The diagnostic programmes 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 programmes

PA 00 Lange medium frequency innervation test PA 01 Neofaradic test PA 02 Chronaxia / accommodation quotient PA 03 Fischgold test

Various programmes with all the pulse shapes suitable for paralysis therapy

are available. The parameters can be modified for the patient depending on the medical history.

Therapy programmes

PA 06 Paralysis treatment with triangular impulse currents (alternating) PA 07 Paralysis, moderate degeneration PA 08 Paralysis, slight degeneration PA 10 Intention exercises (biphasic) PA 11 Muscle rehabilitation for strength (biphasic) PA 12 Muscle rehabilitation for endurance (biphasic)

91

Paralysis diagnostics 19.1 Lange medium frequency test

19

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

Note: By regulating the intensity the Pulse button becomes active..

Implementation

Trigger a single pulse by setting an appropriate intensity and pressing the

button.

Then the test is repeated on healthy muscle. If the two muscles have

approximately the same excitability to the single pulse, the muscle in question is innervated. If there are significant differences in the reaction of the muscles to high excitation intensities, the muscle in question is partially denervated.

92

Paralysis diagnostics 19.2 Neofaradic test

19

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.

Screenshot

Implementation The excitation time is started at one minute by regulating the intensity.

93

Paralysis diagnostics 19.3 Chronaxia/accommodation

quotient

19

This programme is used to conduct a simple and quick diagnosis.

It consists of three steps that measure the rheobase, chronaxia and accommodation threshold, from which the accommodation quotient is calculated.

Screenshot

Rheobase

Surge current magnitude for triggering a minimum muscle twitch with a square-wave pulse of 1000 ms.

Implementation Calculating rheobase

Step 1: Set an appropriate low intensity. Step 2: Trigger a single pulse. Repeat steps 1 and 2 with increasing intensity until a minimum muscle twitch is observed. The rheobase value is calculated using the first minimum muscle twitch.

94


quotient

19

Step 3: Accept rheobase value. By accepting the calculated pulse, 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 chronaxia

Step 1: Increase pulse time in stages (or reduce if required)

Step 2: Trigger a single pulse. Repeat steps 1 and 2 until a minimum muscle twitch is observed. The chronaxie value is calculated using the first minimum muscle twitch.

95


quotient

19

Step 3: Accept chronaxia value.

Accommodation threshold

Surge current magnitude for triggering a minimum muscle twitch with a triangular pulse of 1000 ms.

Surge intensity (mA) of the TPC at 1000ms Accommodation quotient

Surge intensity (mA) of the RPC at 1000ms (rheobase) TPC triangular pulse characteristic

RPC rectangular pulse characteristic

Calculating accommodation threshold

Step 1: Set an appropriate low intensity Step 2: Trigger a single pulse Repeat steps 1 and 2 with increasing intensity until a minimum muscle twitch is observed. The accommodation threshold is calculated using the first minimum muscle twitch.

Step 3: Accept accommodation threshold value

96


quotient

19

Accommodation quotient

By accepting the value of the accommodation threshold, the accommodation quotient is automatically calculated. The calculated values are shown in a window.

Evaluation of the chronaxia

< 0.05 ms Hyperexcitability 0.05–1 ms Normal excitability 1–20 ms Partial degeneration > 20 ms Complete degeneration

Normal chronaxia values (according to Edel) Anterior muscles (front of body)

Proximal: 0.08–0.16 ms Distal: 0.16–0.32 ms

Posterior muscles (back of body) Proximal: 0.16–0.32 ms Distal: 0.44–0.72 ms

Evaluation of the accommodation quotient according to Edel 6–3: normally functioning neuromuscular system

3–2: slight/partial degeneration 2–1: severe/total degeneration

97

Paralysis diagnostics 19.4 Fischgold test

19

This programme 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: Set an appropriate low intensity Step 2: Trigger a single pulse Repeat steps 1 and 2 with increasing intensity until a minimum muscle twitch is observed. Step 3: Accept measured value By accepting the measured value the parameters for measurement phase 2 are automatically accepted.

98

Paralysis diagnostics 19.4 Fischgold test

19

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 the quotients

< 1.7: normally functioning neuromuscular system > 1.7: partial degeneration

If one of the two intensities cannot be calculated, the degeneration is

complete.

99

Indications 20.1 Electrotherapy

20

Therapy to stimulate blood flow

• Functional circulation disorders • Angiopathy in diabetes mellitus • Angioneuropathy (Raynaud’s syndrome) • Acrocyanosis • Arterial occlusive disease (stage I/IIa) • Venous vascular diseases • Chronic venous insufficiency • Sympathetic reflex dystrophy • Sudeck's syndrome (stage II) • Trophic disorder • Lymphoedema • Treatment of facial nerves (as pre-treatment) • Chronically tense muscles • Peripheral joint disease (chronic) • Radicular syndrome in spinal diseases (subacute and chronic) • Ligament ruptures • Tendovaginitis • Bursitis

Analgesic therapy • Distortions, contusions, muscular, tendon and joint sprains

• Widespread myalgia • Polyarthralgia • Joint diseases, inflammatory • Chronic polyarthritis (rheumatoid arthritis), treatment during low inflammation

periods • Diffuse pain in periarthropathy, arthritis, Bechterew’s disease • Tendinitis, tendovaginitis • Local and pseudoradicular spinal syndromes • Nerve root lesion • Intervertebral disc surgery • Inflammatory spinal diseases, chronic • Chronic pain, chronic pain disease • Pelvipathy (adnexitis) • Pelvipathy (prostatitis) • Neuralgias

100

Indications 20.1 Electrostimulation

20

• Neuritis

• Polyneuropathy • Radicular syndrome • Nerve compression syndrome • Allodynia • Causalgia

Trophic stimulation therapy

• Venous ulcers • Neurotrophic ulcers • Decubitus ulcers • Delayed wound healing • Osteoporosis • Delayed bone healing • Ligament ruptures

Muscle toning therapy • Muscular weakness

• Arbitrary innervation weakness • Lack of muscular feeling

Muscle detoning therapy

• Musculature overload • Painful muscle spasms • Myofascial pain syndrome • Tendon and muscle ruptures • Contractures

Other indications • Periarthropathy and insertion tendinopathy (acute, subacute)

• Periarthropathy and insertion tendinopathy (chronic) • Peripheral joint disease (acute, subacute) • Posttraumatic stress disorders (haematoma, oedema) • Excessive sweating on the hands and feet (palmar-plantar hyperhidrosis) • Acquired curvature of the spine: posttraumatic, post-inflammatory,

degenerative • Curvature of the spine in children and adolescents • Spinal fractures, spondylodesis • Joint surgery, arthroscopy, arthrotomy • Congenital defects, deformities or misalignment of the musculoskeletal

system for treatment in childhood

101

Indications 20.1 Electrotherapy

20

• Faecal incontinence

• Urinary incontinence • Intestinal motility disorder • Chronic constipation • Secondary lymphoedema and lymph stasis • Pelvipathy • Polyneuropathy • Anterior horn cell disease of the spinal cord • Peripheral paralysis, plexus paralysis • Non-local, generalised spinal cord diseases • Spasticity • Spastic paralysis • Flaccid paralysis

102

Indications 20.2 Ultrasound therapy

20

Indications from orthopaedics, surgery, traumatology, rheumatology Other indications

• Vertebral pain syndrome, e.g., cervical syndrome • Anyklosing spondylitis (only during inflammation-free periods) • Joint diseases • Rheumatoid arthritis (if heat treatment is indicated) • Joint degeneration • Periarthropathy • Epicondylopathy • Tendinosis, periostitis, heel spurs • Achillodynia • Scars, contractures, Dupuytren’s contracture • Posttraumatic disorders • Fractures (particularly with delayed callus formation) • Bronchial asthma • Rhinopathy • Persistent cervical spine complaints after whiplash injuries with repetitive

blocking • Headaches • Earaches • Postherpetic neuralgia • Functional disorders of the stomach and duodenum • Pelvipathy • Functional complaints of the pelvis minor

103

Contraindications 21. 1 Electrotherapy

21

General contraindications

• Acute inflammation (local, systemic) • Arterial occlusive disease from stage IIb according to Fontaine • Suppurative processes • Fever • General infections • Malignant and benign tumours • Thrombophlebitis • Phlebothrombosis with risk of embolism • Cardiac pacemakers and other implanted electronic devices • Transcardial current flow • Metallic implants in the current region when using galvanic or unipolar

currents with pulse durations greater than 1 ms • Psychoses

Must also be heeded for TENS therapy

• The underlying cause of the pain • Predominantly psychogenic pain (TENS therapy is ineffective) • Central pain syndrome, e.g., thalamic pain syndrome

Additional contraindications

Muscular treatment with surged pulse groups (surging currents) is contraindicated with: • unconsciousness, clouding of consciousness • reflex inhibition (such as with fractures) • muscular inflammation • mimetic facial muscles • if the electrostimulation therapy triggers sustained pain • babies, toddlers • if spasticity increases • pregnancy

Precautionary measures for specific current forms

Diadynamic current, Träbert's current: • Cautious electrode technique is necessary to avoid possible skin damage

due to the high galvanic component of the diadynamic currents. • Cautious dosing with sensitivity disorders Electroacupuncture: • No needle acupuncture with coagulation disorders

104

Contraindications 21.2 Ultrasound therapy

21

General contraindications

• Diseases in which heat should not be applied, e.g., acute inflammatory diseases

• Diseases in which mechanical forces are contraindicated, e.g., phlebothrombosis, haemorrhagic diathesis

• Do not apply ultrasound higher than C3 • Do not apply ultrasound to parenchymatous or heat-sensitive organs

(testes, eyes, pregnant uterus, liver, kidney, etc.) • Anaesthetised skin areas • Temperature regulation disorders • After treatment with ionising radiation • Epiphyseal plates and lines • Tumours • Do not use over electronic pacemakers Metal implants and endoprostheses There are no longer any concerns about dynamic ultrasound application in low doses.

105

Explanation of symbols

22

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.

106

Warnings

23

Please note: Never connect two patients to the device in one session!

Do not use the device in wet rooms (hydrotherapy) or balneotherapy rooms. Do not leave patients unattended during treatment.

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.

! Note:

The above warnings also apply for electrotherapy in combination with the vacuum unit.

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.

107

Warnings

23

Ultrasound therapy 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. The use of coupling agents other than the special ultrasound gel Sono plus may damage the ultrasound head. We recommend Sono plus by Zimmer MedizinSysteme.

Vacuum Do not conduct treatment on patients with a tendency to haematoma unless

the risk has been assessed and found to be negligible.

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.

108

General technical information Soleo SonoStim / Soleo Galva

24

Operating voltage 100–240 V, 220 V / 50/ 60 Hz Power consumption max. 60 VA Protection class II Mains fuse 2 x 3.15 A T

Applied part Type BF Dimensions 322 mm x 234 mm x 130 mm

Weight 2.1 kg

Transport in original packaging only Operational environment

+10°C to + 40°C, 30% to 75% rel. humidity, 700–1060 hPa

Storage +10°C to + 50°C, 10% to 90% rel. humidity,

700–1060 hPa

109

General technical information VacoS

25

Operating voltage 100–120 V or 230–240 V, 220 V / 50/ 60 Hz

(see manufacturing plate) Power consumption max. 50 VA Protection class II Mains fuse 2 x 0.5 A T Applied part Type BF Dimensions 322 mm x 234 mm x 130 mm

Weight 3.0 kg

Transport in original packaging only Operational environment

+10°C to + 40°C, 30% to 75% rel. humidity, 700–1060 hPa

Storage +10°C to + 50°C, 10% to 90% rel. humidity,

700–1060 hPa

110

Specific technical Information 26.1 Stimulation current

26

Power emitted 200 Ω 500 Ω 1000 Ω 2000 Ω Galvanisation GA xx

CC 80 mA 80 mA 80 mA 80 mA CV 14 V 40 V 60 V 60 V

Diadynamic currents DD xx


High voltage currents HV xx

CC 250 mApeak 250 mApeak 250 mApeak 250 mApeak CV 40 Vpeak 140 Vpeak 200 Vpeak 200 Vpeak

Medium frequency currents MF xx


Interference currents IF xx

CC 56 mA 56 mA 56 mA 56 mA CV - V - V - V - V

Microstimulation currents MI xx

CC 1 mApeak 1 mApeak 1 mApeak 1 mApeak CV 0.3 Vpeak 0.6 Vpeak 1 Vpeak 2 Vpeak

Low frequency rectangular currents NF xx

CC 10 mApeak 80 mApeak 80 mApeak 80 mApeak CV 12 Vpeak 40 Vpeak 80 Vpeak 160 Vpeak

111

Specific technical Information 26.2 Ultrasound

26

Ultrasound heads Frequency 800 kHz (0.8 MHz) and 2.4 MHz

Small ultrasound head 1 cm² , ERA = 1.1 cm² at 800 kHz (0.8 MHz), 0.5 cm² at 2.4 MHz Maximum output 1 W at 800 kHz (0.8 MHz), 0.5 W at 2.4 MHz Intensity steps 0.1 to 1 W/cm² eff. in steps of 0.1 W / cm²

Large ultrasound head 5 cm² , ERA = 2.3 cm² at 800 kHz (0.8 MHz), 4 cm² at 2.4 MHz Maximum output 7 W at 800 kHz (0.8 MHz), 10 W at 2.4 MHz Intensity steps 0.1 to 3 W/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 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

Replacement parts Ultrasound heads are factory-calibrated and can be easily replaced.

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Specific technical Information 26.3 VacoS

26.

Negative pressure 12–60 kPa

Pulse operation Period duration adjustable from 1 to 8 s in steps of 0.5 seconds, duty factor

1:1

Accuracy < ± 20 %

(This value represents the legally permissible value required by law, and not the actual accuracy level for each device)

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Cleaning Disinfection

27

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.

Vaco electrodes Clean the suction cups with tap water with standard cleaners (detergent)

added. Any residue on the electrodes can be removed with the help of a hard brush if needed. Disinfect the electrodes with standard alcohol-free disinfectant suitable for plastic.

Sponge holders Rinse 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.

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Electrodes 28.1 Use and care

28

All standard electrodes for electrotherapy can be connected to Soleo SonoStim / Soleo

Galva using insulated cable terminals. Reliable disposable electrodes are particularly suitable. Disposable electrodes offer the advantage of simple, fast, accurate and hygienic application. Flat and rubber electrodes are also available for particularly large scale applications in addition to disposable electrodes. Sponge holders are used to prevent uncovered electrodes from making contact with the skin. The sponge holders must be kept thoroughly moist during treatment, preferably with warm tap water. Attach them with rubber bands or Velcro®. Please note that rubber electrodes may quickly lose conductivity when used with monophase currents. Insert the electrodes fully into the sponge holders and apply to the body with light pressure, ensuring complete contact. The fasteners should not leave any marks. The electrical connection to the electrical cable terminals is similar to that with disposable electrodes. Attach terminals to the plate electrode which is fully inserted into the sponge holder. Rinse sponge holders well with water after every treatment. Cleaning sponges: • thermal disinfection, wash at 95°C • sterilisation in autoclave 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.

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Electrodes 28.2 Information about the use of

various electrode types

28

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 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.

Tin plate electrodes For therapy with purely galvanic current (galvanisation, iontophoresis) large tin

plate electrodes are suitable.

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Electrodes 28.2 Information about the use of

various electrode types

28

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.

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CE Marking

29

The products bear the CE marking

in accordance with EU Medical Devices Directive 93/42/EEC and meets the essential requirements of Annex I to this Directive. The product Soleo SonoStim is rated in Class IIb according to Annex IX of the Directive. The product Soleo Galva is rated in Class IIa according to Annex IX of the Directive. The product VacoS is rated in Class IIa according to Annex IX of the Directive. Soleo SonoStim / Soleo Galva / VacoS have been developed, manufactured and tested under the ISO 13485 quality management system.

118

Contents on delivery Accessories 30.1 Soleo SonoStim

30

Contents on delivery Soleo SonoStim 2 pairs of electrode cables, incl. 2 red and 2 black alligator clips, 2.90 m

long 1 variable frequency ultrasound head 0.8 and 2.4 MHz, ø 28 mm 1 storage tray, right 1 storage tray, left 1 mains cable 2 touch pens

Accessories Item No. 65800410 Touch pen 118 Mains cable 65910320 Storage tray, right 65910310 Storage tray, left Electrotherapy 153 2 pairs of electrode cables, incl. 2 red and 2 black alligator clips

68910111 1 pair electrode cables, 2.90 m

31100146 Alligator clip red 31100147 Alligator clip black 21 Disposable electrodes, 135 pairs, small (1 package) 22 Disposable electrodes, 90 pairs, medium (1 package) 23 Disposable electrodes, 45 pairs, large (1 package) 43 Plate electrodes 9 x 12 cm, pure tin 96 Iontophoresis sponge 212 Membrane foil for iontophoresis (1 package)

Package: 1000 units, 180 x 120 cm 44 Rubber electrode 50 x 50 mm, 1 pair 97 Sponge holder for #44, 1 pair 46 Rubber electrode 50 x 100 mm, 1 pair 98 Sponge holder for #46, 1 pair 232 Rubber band, 60 cm gel, with button 233 Rubber band, 120 cm gel, with button 230 Velcro® tape, 60 cm long, 10 cm wide 231 Velcro® tape, 120 cm long, 10 cm wide Ultrasound therapy 4100XXX Variable frequency ultrasound head 0.8 and 2.4 MHz, ø 28 mm 4101XXX Variable frequency ultrasound head 0.8 and 2.4 MHz, ø 13 mm 6 Sono plus, 1 bottle

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Contents on delivery Accessories 30.2 Soleo Galva

30

Contents on delivery Soleo Galva 2 pairs of electrode cables, incl. 2 red and 2 black alligator clips, 2.90 m

long 1 storage tray, right 1 storage tray, left 1 mains cable 2 touch pens

Accessories Item No. 153 2 pairs of electrode cables, incl. 2 red and 2 black alligator clips

68910111 1 pair electrode cables, 2.90 m 31100146 Alligator clip red 31100147 Alligator clip black 21 Disposable electrodes, 135 pairs, small (1 package) 22 Disposable electrodes, 90 pairs, medium (1 package) 23 Disposable electrodes, 45 pairs, large (1 package) 43 Plate electrodes 9 x 12 cm, pure tin 96 Iontophoresis sponge 212 Membrane foil for iontophoresis (1 package)

Package: 1000 units, 180 x 120 cm 44 Rubber electrode 50 x 50 mm, 1 pair 97 Sponge holder for #44, 1 pair 46 Rubber electrode 50 x 100 mm, 1 pair 98 Sponge holder for #46, 1 pair 232 Rubber band, 60 cm gel, with button 233 Rubber band, 120 cm gel, with button 230 Velcro® tape, 60 cm long, 10 cm wide 231 Velcro® tape, 120 cm long, 10 cm wide 65800410 Touch pen 118 Mains cable 65910320 Storage tray, right 65910310 Storage tray, left

120

Contents on delivery Accessories 30.3 VacoS

30

Contents on delivery VacoS 1 pair of Vaco electrode sleeves, red, 1.60 m long

1 pair of Vaco electrode sleeves, black, 1.60 m long 2 pairs of Vaco self-sealing electrodes, 90 mm diameter, with sponges 2 pairs of Vaco self-sealing electrodes, 60 mm diameter, with sponges 2 connecting cables for Soleo SonoStim / Soleo Galva 1 mains connecting cable, short 4 sorting racks for Vaco electrode sleeves 1 water bottle

Accessories Item No. 95 Viscose sponge, large for #72

94 Viscose sponge, small for #71 72 Vaco electrode, ø 90 mm, self-sealing 71 Vaco electrode, ø 60 mm, self-sealing 164 Vaco electrode sleeves, red, 1.60 m long 165 Vaco electrode sleeve, black, 1.60 m long 68910210 Connecting cable for Soleo SonoStim / Soleo Galva 119 Mains connecting cable, short 65350110 Sorting rack 95920000 Water bottle

121

Device combinations

31

Soleo SonoStim and Soleo Galva can be combined with VacoS. The party

that combines and uses the devices as a medical system is responsible for correct assembly of the devices.

122

Safety and maintenance

32

Soleo SonoStim / Soleo Galva are produced in accordance with the safety

requirements of EN 60601-1.

Zimmer MedizinSysteme 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 and the

electrical installation conforms to DIN VDE 0100 Part 710 • if the device is operated in accordance with the Operating Instructions • if extensions, reconfigurations or modifications are implemented only by

persons authorised by Zimmer MedizinSysteme • users must ensure that the device is operating correctly and is in good

repair before using it • before every use check the ultrasound head, cables and connectors for

damage (such as cracks) that could adversely affect the safety of the device

• the device must be operated by appropriately 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.

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Functional test

33

Soleo SonoStim / Soleo Galva 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 Select program GA 00. Insert test adapter (test Patient).

The display in the bar graph must be completely full at maximum intensity. Run the test consecutively with both channels.

Ultrasound Select ultrasound head and cover the ultrasound head with gel. The coupling

display must show over 90% at low power and at the start of therapy. Run the test consecutively using both ultrasound heads. Then clean ultrasound heads.

Vacuum Select vacuum and establish start vacuum. Short-circuit Vaco electrodes and

set maximum vacuum. The bar graph must be completely full in continuous mode.

Vaco electrodes Turn the Vaco electrodes to the outside so that the electrode surface is no

longer enclosed by the rubber lip and generate the vacuum. VacoS must have steady suction.

124

Technical safety checks

34

National laws and regulations must be observed when installing and

operating the therapy devices Soleo SonoStim and Soleo Galva.

General information

Store the Operating Instructions so they are accessible to operators of the device at all times. Access must be available for inspection authorities at any time.

125

Error messages Troubleshooting Disposal

35

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.

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35

No SD card found

If the SD card is not inserted, the message ‘No SD card found’ appears when the Indications, Favourites and Memory buttons are pressed. Insert the card and confirm with OK.

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35

VacoS No suction

If VacoS does not achieved the specified suction, there may be a leak in the system. In this case: • Check that all four Vaco electrode sleeves are attached and connected

with a Vaco electrode. • Check that the Vaco electrodes are correctly applied to the patient.

Vacuum button deactivates

If the Vacuum button deactivates, there may be a transmission error. In this case:

• Check if Soleo SonoStim / Soleo Galva are correctly placed on VacoS.

• Check if Soleo SonoStim / Soleo Galva are correctly attached to VacoS via the connecting cable.

• Check if VacoS is switched on.

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VacoS Water separator full

If the water separator is full the message ‘Empty water separator’ appears on the screen.

Note:

If the water separator is not emptied, therapy cannot be started. The water separator is emptied by using a water bottle which is supplied with VacoS. The connector valve to empty the water separator is found on the right side of the VacoS.

Connecting the bottle

On the hose of the water bottle, there is a quick-release fastener that is attached to the valve on the device.

Empty the water separator

Squeezing the bottle creates suction which is used to empty the water separator. Under some circumstances repeatedly creating suction is necessary to completely empty the water separator.

Disconnecting the bottle

The bottle is removed from the connector valve by squeezing on the side of the quick-release fastener on the tube of the water bottle and simultaneously withdrawing the connector. The lid of the bottle is removed by twisting so that the bottle can be emptied. We recommend emptying the water separator every day. Finally, confirm the message ‘Empty water separator’ with OK.

Note: VacoS and Duostim separate mode

In ‘Duostim separate’ mode, dual cycle vacuum application is not possible. In ‘Duostim separate’ mode only channel I is active for the vacuum application. Channel II cannot be operated with vacuum application.

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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 your authorised sales representative or by contacting the head office in Neu-Ulm, Germany.

The device must be sent to the factory in the original packaging only.

Head office Zimmer MedizinSysteme GmbH Junkersstraße 9 89231 Neu-Ulm, Germany Tel. +49 731. 9761-291 Fax +49 731. 9761-299 www.zimmer.de

Disposal The device must be disposed of by an approved disposal company and must

not be discarded with household or special waste.

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Manufacturer's EMC declaration

36

Medical electrical devices such as Soleo SonoStim / Soleo Galva are subject to special precautions regarding electromagnetic compatibility (EMC) and must be installed and put into service according to the EMC information provided in these operating instructions for use and any accompanying documents.

Portable and mobile RF communications devices (such as mobile telephones) may interfere with medical electrical devices.

Soleo SonoStim / Soleo Galva should only be operated with the original mains cable specified in the list of contents delivered. The use of accessories other than those specified may result in increased emissions or decreased immunity of the device.

Guidance and manufacturer's declaration – electromagnetic emissions

The Soleo SonoStim / Soleo Galva is intended for use in one of the electromagnetic environments specified below. The customer or the user of the Soleo SonoStim / Soleo Galva device should ensure that the device is used in such an environment.

Emissions tests Compliance Electromagnetic environment – guidance

RF emissions CISPR 11 Group 2 The Soleo SonoStim / Soleo Galva device must emit electromagnetic energy in order to perform its intended function. Nearby electronic equipment may be affected.

RF emissions CISPR 11 Class B

Harmonic emissions IEC 61000-3-2 Class A

Voltage fluctuation emissions and flicker IEC 61000-3-3

Complies

The Soleo SonoStim / Soleo Galva device is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Table 201 as per EN 60601-1-2:2006-10

The device should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the device should be monitored to verify normal operation in the configuration in which it will be used.

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Guidance and manufacturer's declaration – electromagnetic immunity


Immunity tests IEC 60601 test level Compliance level Electromagnetic environment - Guidance

Electrostatic discharge (ESD) IEC 61000-4-2

± 6 kV contact ± 8 kV air

± 6 kV contact ± 8 kV air

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

Electrical fast transient/burst IEC 61000-4-4

± 2 kV for mains power lines ± 1 kV for input/output lines

± 2 kV for mains power lines Not applicable

The quality of the supply voltage should correspond to a typical business or hospital environment.

Surge IEC 6100-4-5

± 1 kV differential mode ± 2 kV common mode

± 1 kV differential mode ± 2 kV common mode



<5% UT (>95% dip in UT for 0.5 cycle) 40% UT (>60% dip in UT for 5 cycles) 70% UT (>30% dip in UT for 25 cycles) <5% UT (>95% dip in UT for 5 sec)

<5% UT (>95% dip in UT for 0.5 cycle) 40% UT (>60% dip in UT for 5 cycles) 70% UT (>30% dip in UT for 25 cycles) <5% UT (>95% dip in UT for 5 sec)

Mains power quality should be that of a typical commercial or hospital environment. If the user of the Soleo SonoStim / Soleo Galva requires continued operation during power mains interruptions, it is recommended that the Soleo SonoStim / Soleo Galva be powered from an uninterruptible power source.

Power frequency (50/60 Hz) magnetic field IEC 61000-4-8

3 A/m 3 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

Note: UT is the AC mains voltage prior to application of the test level.

Table 202 as per EN 60601-1-2:2006-10

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Fundamental performance characteristics of the Soleo SonoStim / Soleo Galva (stimulation current only) are: interference-free output of stimulation current and ultrasound, and in combination with the Vaco vacuum unit also of suction, with the specified parameters and interference-free operation of all functions.

Guidance and manufacturer's declaration – electromagnetic immunity


Immunity tests

IEC 60601 test level

Compliance level Electromagnetic environment – Guidance

Conducted RF IEC 61000-4-6 Radiated RF IEC 61000-4-3

3 Vrms 150 kHz to 80 MHz 3 V/m 80 MHz to 2.5 GHz

3 Vrms 150 kHz to 80 MHz 10 V/m 80 MHz to 2.5 GHz

Portable and mobile RF communications equipment should be used no closer to any part of Soleo SonoStim / Soleo Galva, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance: d= 1.17 √P d= 0.35 √P for 80 MHz to 800 MHz d= 0.7 √P for 800 MHz to 2.5 GHz where P is the maximum output power rating of the transmitter in Watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site surveya, should be less than the compliance level in each frequency rangeb. Interference may occur in the vicinity of equipment which is marked with the following symbol:

NOTE 1 At 80 Hz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

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a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast, cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location where the device Soleo SonoStim / Soleo Galva is used exceeds the applicable RF compliance level above, the device Soleo SonoStim / Soleo Galva should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the device Soleo SonoStim / Soleo Galva. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

Recommended separation distances between portable and mobile RF telecommunications equipment and the Soleo SonoStim / Soleo Galva device

The Soleo SonoStim / Soleo Galva device is intended for use in an environment in which radiated RF disturbances are controlled. The customer or user of the Soleo SonoStim / Soleo Galva device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF telecommunications equipment (transmitters) and the Soleo SonoStim / Soleo Galva device, as recommended below, according to the maximum output power of the communications equipment.

Separation distance according to frequency of transmitter m

Rated maximum output power of transmitter W

150 kHz to 80 MHz d= 1.17 √P

80 MHz to 800 MHz d= 0.35 √P

800 MHz to 2.5 GHz d= 0.7 √P

0.01 0.12 0.04 0.07

0.1 0.37 0.11 0.22

1 1.17 0.35 0.7

10 3.70 1.11 2.21

100 11.67 3.5 7.0

For transmitters rated at a maximum output power which is not listed above, the recommended separation distance d in metres (m) can be determined using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in Watts (W) according to the transmitter manufacturer. NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

We reserve the right to make changes.

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Zimmer MedizinSysteme GmbHJunkersstraße 9D-89231 Neu-UlmTel. +49 731. 97 61-291Fax +49 731. 97 [email protected] www.zimmer.de

Operating Instructions

Documents

Bedienung Soleo Galva SonoStim GB · Paralysis diagnostics and therapy overview 90 19.1 Lange medium frequency test 91 19.2 ... The compact design saves room in the practice and is