User Manual

Soleoline

Soleo SonoStim, Soleo Stim

USA
 Soleo SonoStim / Soleo Stim
Front view of device

5
Fig. 1

4 4

3 3

1 2
7
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

10
Fig. 2

11
9

Screen readouts
8 Status bar 10 Title bar
9 Navigation bar 11 Buttons on the screen
 Soleo SonoStim / Soleo Stim
Rear view of device

Fig. 3

16 17
15 18
14

12

13

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
 Contents

Soleo SonoStim / Soleo Stim

Front view of device
Selection and control elements/screen readouts

Rear view of device

Switch and connector sockets

Page

1. Indications
1.1 Electrotherapy 1
1.2 Ultrasound therapy 2

2. Contraindications, Cautions 3
2.1 Electrotherapy 4
2.2 Ultrasound therapy 5

3. Warnings
3.1 General 6
3.2 Electrotherapy 7
3.3 Ultrasound therapy 8

4. Soleoline – Summary 9
5. Fitting the cables, starting the system
5.1 Soleo SonoStim / Soleo Stim 10

6. Configuration
6.1 General 11
6.2 Electrotherapy 17
6.3 Ultrasound therapy 19
6.4 Maintenance 21

7. Soleo SonoStim – Quick operating instructions

7.1 Electrotherapy 22
7.2 Ultrasound therapy 26
7.2.1 Water bath treatment 30
7.3 Combined therapy 32

8. Soleo Stim – Quick operating instructions 36

9. General information –SD card 37

 Contents
Page

10. Description of the selection buttons 38

11. Electrotherapy – Screenshots of the various therapy screens 44

12. Electrotherapy
12.1 Description of the screen elements 46
12.2 Description of the parameter button 48
12.3 Description of the On/Off time button 50
12.4 Change current form parameters 52
12.5 Change On/Off time parameters 56
12.6 Description of the screen elements and the interference button 59

13. Ultrasound therapy – Screenshot of the therapy screen 60

14. Ultrasound therapy

14.1 Description of screen elements 61
14.2 Description of the parameter button 64
14.3 Description of the Frequency button 67

15. Combined therapy – Screenshot of the therapy screen 68

16. Indications menu 69

17. Saving a modified programme 72

17.1 Fast Path 74
17.2 Memory 75

18. Retrieving and editing fast path and memory

18.1 Retrieving fast path 76
18.2 Editing fast path 77
18.3 Retrieving and editing memory 79

19. Explanation of symbols 80

20. General technical information 81

Soleo SonoStim / Soleo Stim

21. Specific technical Information

21.1 Stimulation current 82
21.2 Ultrasound 83

22. Cleaning, Disinfection 84

23. Electrodes
23.1 Use and care 85
23.2 Information about the use of various electrode types 86
 Contents
Page

24. Contents on delivery, Accessories

24.1 Soleo SonoStim 87
24.2 Soleo Stim 88

25. Safety and maintenance 89

26. Functional test 90

27. Technical safety checks 91

28. Error messages, Troubleshooting, Disposal 92

29. Manufacturer's EMC declaration 94

Valid for Soleo SonoStim, Soleo Stim.
These Operating Instructions are an integral part of the device.
They must be stored with the device and kept accessible at all times for anyone authorised to operate
this device.
These Operating Instructions are valid from 16.07.2012

U.S.A. Federal Law restricts this device to sale by or on the order of a practitioner licensed by the law of
the State in which he/she practices to use or order the use of the device.
 Indications 1

1.1 Electrotherapy
Indications for use

Indications for Pain

Management

IFC, Premodulated, • Symptomatic relief or management of chronic, intractable pain

Microcurrent, • Post-traumatic acute pain
Biphasic Currents • Post-surgical acute pain

Indications for • Relaxation of muscle spasm

• Increasing local blood circulation
Medium Frequency, • Prevention or retardation of disuse atrophy
Monophasic Currents, • Maintaining or increasing range of motion
Biphasic Symmetric • Muscle re-education
Currents and High • Immediate postsurgical stimulation of calf muscles to prevent venous
Voltage thrombosis

1
 Indications 1

1.2 Ultrasound therapy

Indications for use • Relief of pain, muscle spasms and joint contractures
• Relief of pain, muscle spasms and joint contractures that may be
associated with:
o Adhesive capsulitis
o Bursitis with slight calcification
o Myositis
o Soft tissue injuries
o Shortened tendons due to past injuries and scar tissues
• Relief of pain, muscle spasms and joint contractures resulting from:
o Capsular tightness
o Capsular scarring

2
 Contraindications, Cautions 2

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

Caution
Text with “Caution” indicator will explain possible safety infractions that could
have the potential to cause minor to moderate injury or damage to equipment.

Warning
Text with “Warning” indicator will explain possible safety infractions that will
potentially cause serious injury and equipment damage.

3
 Contraindications, Cautions 2

2.1 Electrotherapy
Contraindications • Powered muscle stimulators should not be used on patients with cardial
demand pacemakers.
• Other contraindications are patients suspected of carrying serious
infectious disease and or disease where it is advisable, for general
medical purposes, to suppress heat or fevers.
• Caution should be used for patients with suspected or diagnosed heart
problems.
• Caution should be used for patients with suspected or diagnosed
epilepsy.
• Caution should be used in the presence of the following:
o When there is a tendency to hemorrhage following acute trauma or
fracture;
o Following recent surgical procedures when muscle contraction may
disrupt the healing process;
o Over the menstruating or pregnant uterus; and
• Over areas of the skin which lack normal sensation.
• This device should not be used for symptomatic local pain relief unless
etiology is established or unless pain syndrome has been diagnosed.

Cautions • Safety of powered muscle stimulators for use during pregnancy has not
been established.
• Some patients may experience skin irritation or hypersensitivity due to
the electrical stimulation or electrical conductive medium. The irritation
can usually be reduced by using an alternate conductive medium, or
alternate electrode placement.
• Electrode placement and stimulation settings should be based on the
guidance of the prescribing practitioner.
• Powered muscle stimulators should be kept out of the reach of children.
• Powered muscles stimulators should be used only with the leads and
electrodes recommended for use by the manufacturer.
• The effectiveness of TENS waveforms is highly dependent upon patient
selection by a person qualified in pain management.
• Inspect patient cables and associated connectors before each use

Adverse Effects • Skin irritation and burns beneath the electrodes have been reported with
the use of powered muscle stimulators.
• Potential adverse effects with TENS are skin irritation and electrode
burns.

4
 Contraindications, Cautions 2

2.2 Ultrasound therapy

Contraindications • This device should not be used on any patient with obtuned reflexes or
any area that has significant diminished pain sensitivity or heat
sensitivity.
• This device should not be used for symptomatic local pain relief unless
etiology is established or unless pain syndrome has been diagnosed.
• This device should not be used over or in a region of tumor/malignancy.
• This device should not be used when open wounds are present in the
treatment area.
• This device should not be used directly over the portion of the spinal
cord that is no longer protected by bone following a laminectomy.
• This device should not be used on patients suspected of carrying
serious infectious disease and or disease where it is advisable, for
general medical purposes, to suppress heat or fevers.
• This device should not be used over or near bone growth centers until
bone growth is complete.
• This device should not be used over a healing fracture.
• This device should not be used over the thoracic area of any patient that
has a cardiac pacemaker of any kind.
• This device should not be used over the reproductive organs.
• This device should not be used over or applied to the eye.
• This device should not be used over the abdomen, pelvic or lumbar
regions of pregnant or potential pregnant patient.
• This device should not be used on ischemic tissues in individuals with
vascular disease where the blood supply would be unable to follow the
increase in metabolic demand and tissue necrosis might result.

Metal implants and endoprostheses

There are no longer any concerns about dynamic ultrasound application in

low doses.

Cautions • Before each use, inspect the ultrasound heads for cracks, which may
allow the ingress of conductive fluid
• Over an area of the spinal cord following:
o Laminectomy, i.e., when major covering tissues have been
removed
o Over anesthetic areas
o On patients with hemorrhagic diatheses

5
 Warnings 3

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

U.S.A. Federal Law restricts this device to sale by or on the order of a

practitioner licensed by the law of the State in which he/she practices to use
or order the use of the device.

Do not use the device in wet rooms (hydrotherapy) or balneotherapy rooms.

Do not leave patients unattended during treatment.

This device is exclusively for use by qualified medical personnel. This device
may cause malfunctioning in or may interfere with the operation of devices in
its vicinity. It may be necessary to take action to avoid interference such as
using a different alignment, moving the device or shielding it.

Make certain that the unit is grounded by connecting only to a grounded

electrical service receptacle conforming to the applicable national and local
electrical codes.

Before administering any treatment to a patient you should become

acquainted with the operating procedures for each mode of treatment
available, as well as the indications, contraindications, warning and
precautions. Consult other resources for additional information regarding the
application of electrotherapy and ultrasound therapy.

To prevent electrical shock, disconnect the unit from the power source before
attempting any maintenance or cleaning procedure

Handle the ultrasound head carefully as rough treatment may alter its
properties. Do not bring the ultrasound head into contact with sharp or pointed
objects as the aluminium head is easily scratched.

Handle, clean and dispose of components and accessories that have come in
contact with body fluids according to national, local and facility rules,
regulations and procedures

6
 Warnings 3

3.2 Electrotherapy
Electrotherapy • Do not conduct electrotherapy treatment on patients with implants or any
other implanted electronic device unless the risk has been assessed and
found negligible.
• Patients must not be connected to a radio-frequency surgical device at
the same time. This may cause burns under the electrotherapy
electrodes.
Operation of the electrotherapy device in the vicinity (e.g., within 1 m) of
strong electromagnetic fields (e.g., tomographs, X-ray or diathermy
devices) may cause oscillations in the output values of the
electrotherapy device.
• Please maintain a safe distance of several metres.
• The recommended maximal current density for currents that could cause
burns (e.g., galvanic current, diadynamic currents, current with a
galvanic component) is 2 mA eff/cm² electrode surface.
• If the current density exceeds 2 mA eff/cm², users must be extremely
vigilant during treatment.
• Positioning the electrodes in the vicinity of the chest may increase the
risk of cardiac fibrillation.
• When using different electrodes, note that a smaller electrode surface
area may result in a higher current density.
• The long-term effects of chronic electrical stimulation are unknown.
• Stimulation should not be applied over the carotid sinus nerves,
particularly in patients with a known sensitivity to the carotid sinus reflex.
• Stimulation should not be applied over the neck or mouth. Severe
spasm of the laryngeal and pharyngeal muscles may occur and the
contractions may be strong enough to close the airways or cause
difficulty in breathing.
• Stimulation should not be applied transthoracically in that the
introduction of electrical current into the heart may cause cardiac
arrhythmias.
• Stimulation should not be applied transcerebrally.
• Stimulation should not be applied over swollen, infected, or inflamed
areas or skin eruptions, e.g., phlebitis, Thrombophlebitis, varicose veins,
etc.
• Stimulation should not be applied over, or in proximity to, cancerous
lesions.

If the intensity control is increased, there may be currents greater than

10 mA eff and voltages greater than 10 V may apply at the outlet
sockets.

7
 Warnings 3

3.3 Ultrasound therapy

Ultrasound therapy • Caution: Use of controls or adjustments or performance of procedures
other than those specified herein may result in hazardous exposure to
ultrasonic energy.
• Do not conduct ultrasound therapy on patients with implants or any other
implanted electronic device unless the risk has been assessed and found
to be negligible.
• Patients must not be connected to a radio-frequency surgical device at
the same time. This may result in burns.
• Operation of the ultrasound device in the vicinity (e.g., within 1 m) of
strong electromagnetic fields (e.g., tomographs, X-ray or diathermy
devices) may interfere with the operation of the device. Please maintain a
safe distance of several metres.
• Handle the ultrasound head carefully as rough treatment may alter its
properties. Do not bring the ultrasound head into contact with sharp or
pointed objects as the aluminium head is easily scratched.
• Disinfect the ultrasound head with standard disinfectants after use.
• Use a coupling agent which is intended for ultrasound treatment and has
high electrical conductivity.
• Use a coupling agent which is a cleared medical device on the US
market.

8
 Soleoline – Summary 4

What is Soleoline? An ultramodern and innovative range of products with 3 different devices
available.

Soleo SonoStim
An ultramodern and innovative combination device for electrotherapy and
ultrasound therapy.
Soleo Stim
An ultramodern and innovative electrotherapy device.
Soleo Sono
An ultramodern and innovative ultrasound therapy device.

Note: The operation of Soleo Sono is described in a separate set of instructions.

What does the Output of monophasic, biphasic and medium frequency currents for nerve
Soleoline do? stimulation and muscle therapy for mono channel and dual channel operation
as well as output of therapeutic ultrasound.

What are the A clear contemporary colour screen showing all parameters necessary for
advantages of therapy as well as modern touch control.
Soleoline? Individual programme start configuration and clear, simple menu navigation
make operation of the device easy and comfortable for users.
The combination of electrotherapy and ultrasound therapy in a single system
enables the use of the established Combined therapy.
The compact design saves room in the practice and is highly suited for use in
home visits.

Innovations in SonoSwing, the innovation in the field of ultrasound therapy:

Soleoline? • 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).

9
 Fitting the cables 5
Starting the system

5.1 Soleo SonoStim / Soleo Stim

Note: The following description of fitting the cables refers to the operation of Soleo
SonoStim / Soleo Stim.

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

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

Note: All buttons, menus and submenus are activated directly on the screen by
touching it or using the touch pen.

10
 Configuration 6

6.1 General
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.

11
 Configuration 6

6.1 General
Configuration menu In the configuration menu the factory settings can be changed and individually
set. After activation of the configuration menu the ‘Select configuration’ screen
is active.

Saving settings
Press the button to save the new settings.

Quitting the
configuration menu
Press the button to return to the start screen.

General settings

The setting options are outlined below.

In the factory the default settings are pre-programmed as shown on the
screen.

Language
Press the arrow key to open the
drop-down menu to select the language.

The language is selected by pressing on the appropriate row.

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 Configuration 6

6.1 General
Start settings Configuration options for the program start settings:

Press the arrow key to open the

drop-down menu to select the program start configurations.

The options are selected by pressing on the appropriate row.

Note: This section will determine what screen the unit defaults to when ‘Start’ is
pressed from the ‘Start Display’ screen.

Start display Option to choose between 2 start display screens:

Press the arrow key to open the

drop-down menu to select the start screen.

The selection is made by pressing on the appropriate row.

13
 Configuration 6

6.1 General
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 buttons to

open the window to adjust the volume.

The volume is adjusted using both arrow keys.

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

Press the arrow buttons to adjust the screen brightness.

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 Configuration 6

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

Press the arrow buttons to set the time until the screen saver is enabled.

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

Welcome message Option to configure an individual welcome message.

Activate the Welcome message field

to open the screen keyboard to enter a welcome message.

Note: Press for upper case letters and additional symbols.

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 Configuration 6

6.1 General
Setting defaults

Press the button to reset the unit to the factory default settings.

Version

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

Press the OK button to close the window.

16
 Configuration 6

6.2 Electrotherapy
Electrotherapy Activate the menu
settings

to open the ‘Electrotherapy configuration’ screen.

The settings required for therapy can be adjusted here.

Time Option to configure a uniform therapy time of 1 to 60 minutes for all programs.

Use the arrow buttons to adjust time to desired setting.

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

Use the arrow buttons to adjust time to desired setting.

17
 Configuration 6

6.2 Electrotherapy
Frequency Option to adjust the default carrier frequency to 2500 Hz, 4000 Hz or 8000 Hz:

The frequency is selected using both arrow keys.

Note: The device is preset with a default carrier frequency of 8000 Hz. If you modify
the carrier frequency in this menu, the name of programs MF00 to MF04 and
PM00 to PM06 will remain with 8000Hz. The programs themselves will work
with the frequency selected in this menu.

18
 Configuration 6

6.3 Ultrasound therapy

Note: Activation of the ‘Ultrasound Therapy’ menu and the associated settings is
only possible in the Soleo SonoStim version.

Ultrasound therapy Press the tab

settings

to open the ‘Ultrasound therapy configuration’ screen.

The settings required for therapy can be adjusted here.

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

Note: The threshold is adjusted using both arrow keys.

When coupling drops below the set percentage, an acoustic signal sounds
and therapy will pause. The unit’s default setting is 75%.

19
 Configuration 6

6.3 Ultrasound therapy

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

Press the arrow

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

The unit is selected by pressing on the appropriate row.

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 Configuration 6

6.4 Maintenance
Updates Press the tab

to open the ‘Maintenance’ screen.

The maintenance programs are protected by passwords. Use the keyboard to

insert the password.

To open the update menu, enter the password ‘armin’.

Software can be updated using the updates menu.
You will receive the latest information about updating software when an
update is planned.

For servicing other passwords are necessary. Servicing is permissible by

Zimmer MedizinSystems technicians or technicians trained by
Zimmer MedizinSystems only.

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 Soleo SonoStim 7
Quick operating instructions

7.1 Electrotherapy
Note: The following note applies to all therapy forms available in the system.

Changing the therapy time can result in a modification of the effects and the
patient must be carefully monitored during treatment.

Starting the program

Press the button to open the ‘Program’ screen. The program is

selected here.

SonoStim There are 3 different programmes available in SonoStim.

program
- Electrotherapy
- Ultrasound therapy
- Combined therapy

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 Soleo SonoStim 7
Quick operating instructions

7.1 Electrotherapy
Selecting Electrotherapy is selected by pressing on the appropriate row.
electrotherapy

The following description refers to the electrotherapy program.

Selecting Select the current forms group by pressing on the appropriate row (here
current forms group Neuromuscular Electrical Stimulation (NMES)).

23
 Soleo SonoStim 7
Quick operating instructions

7.1 Electrotherapy
Selecting current form Select the current form by pressing on the appropriate row (here AB 00).

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

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 Soleo SonoStim 7
Quick operating instructions

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

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

The therapy time is automatically reset at the end of the therapy.

25
 Soleo SonoStim 7
Quick operating instructions

7.2 Ultrasound therapy

Starting the program

Press the button to open the ‘Program’ screen. The program is

selected here.

Selecting ultrasound Ultrasound therapy is selected by pressing on the appropriate row.

therapy

26
 Soleo SonoStim 7
Quick operating instructions

7.2 Ultrasound therapy

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

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

Note: Check that the information shown on the Parameter button (here 5 cm2)
matches the ultrasound head connected before starting therapy.

27
 Soleo SonoStim 7
Quick operating instructions

7.2 Ultrasound therapy

Setting intensity Adjust the intensity using the intensity controller on the left.

Starting therapy Press the button to start the therapy.

The display in the bottom status bar changes from ‘Ready’ to ‘Active’ with the
start of therapy and the ‘Start’ button changes to ‘Stop’. The intensity setting
is shown in the bar graph and the therapy time counts down in seconds. The
coupling display is active once the treatment is started.

28
 Soleo SonoStim 7
Quick operating instructions

7.2 Ultrasound therapy

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

The therapy time is automatically reset and the ‘Stop’ button changes to ‘Start’
at the end of the therapy.

29
 Soleo SonoStim 7
Quick operating instructions

7.2.1 Water bath treatment

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’ By pressing the ‘Water bath’

button

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

30
 Soleo SonoStim 7
Quick operating instructions

7.2.1 Water bath treatment

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

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

Continuing therapy in Press the button

the water bath

If the next therapy treatment will be with a water bath.

Ending therapy in the Press the button

water bath

If the next therapy treatment will not be with a water bath.

Note: Once therapy in the water bath is complete, the temperature of the ultrasound
head may be too high for treatment outside the water bath.

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

31
 Soleo SonoStim 7
Quick operating instructions

7.3 Combined therapy

Starting the program

Press the button to open the ‘Program’ screen. The program is

selected here.

Selecting Combined Select Combined therapy by pressing on the appropriate row.

therapy

32
 Soleo SonoStim 7
Quick operating instructions

7.3 Combined therapy

Selecting the Select the desired Combined therapy program by pressing on the appropriate
program row.

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

33
 Soleo SonoStim 7
Quick operating instructions

7.3 Combined therapy

Setting intensity of the Adjust the intensity using the intensity controller on the left.
ultrasound

Starting therapy Combined therapy is activated by adjusting the intensity using the intensity
controller on the right.

Setting intensity of
stimulation current

The display in the bottom status bar changes from ‘Ready’ to ‘Active’. In the
left bar graph, the adjusted ultrasound dose is shown and the coupling display
is active. In the right bar graph, the actual current flow is shown. The therapy
time counts down in seconds.

Note: With Combined therapy, always ensure that the conducting electrode cable
(anode) is only active on channel I. The second electrode is then the
ultrasound head.

34
 Soleo SonoStim 7
Quick operating instructions

7.3 Combined therapy

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

The therapy time is automatically reset at the end of the therapy.

35
 Soleo Stim 8
Quick operating instructions

Starting the program

Press the button to open the ‘Program’ screen.

Selecting current Select the current forms group by pressing on the appropriate row (here
forms group Neuromuscular Electrical Stimulation (NMES)).

Note: The additional steps required to carry out the therapy are described in more
detail in Section 7.1.

36
 General information 9

SD card
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, Fast Path and Memory buttons are pressed.

Deactivate the message as described in Section 28.

37
 Description of the selection buttons 10

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.

Fast Path Press the button

• to open Fast Path for editing

• to add the program to Fast Path in memory mode.

Programs Press the button to open the Programs window.

Indications Press the button to open the indications menu.

38
 Description of the selection buttons 10

Memory Press the button

• to open the memory list for editing

• to add the program to the memory list in memory mode.

Channel Press the button to open the channel mode.

When the button is pressed different channel mode options can be selected.

Mode Group

Activates Monostim, 1-channel therapy.

The exceptions are pre-programmed dual channel currents, e.g. interference
currents.

Activates Twinstim, 2-channel therapy.

The same 1-channel current form runs on channel 1 and channel 2.

Activates Duostim, 2-channel therapy.

Different 1-channel current forms run on channel 1 and channel 2.

Note: Twinstim and Duostim will use one user-defined treatment timer with
independent intensity settings.

39
 Description of the selection buttons 10

Channel Group In Monostim mode, channel 1 or channel 2 can be activated for the desired
therapy.

Activates channel I, channel I is active.

Activates channel II, channel II is active.

Synchronisation group The surge output is defined here for the Twinstim and Duostim modes.

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

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

Independent activation:
The current forms are started and stopped separately on both channels.
The surges are independent of one another.

Note: Independent activation can only be activated in Duostim mode.

40
 Description of the selection buttons 10

Press the button to select a different current form for channel I.

Press the button to select a different current form for channel II.

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

Saving Press the button to open the screen to save a program.

The ‘Save’ button can only be pressed from the therapy screen.

Back Press the button to go back one screen.

Editing Press the button

• to open the ‘Memory’ screen to edit the memory list

• to open the ‘Fast Path’ screen to edit Fast Path

41
 Description of the selection buttons 10

Moving Press the button to move the order of the list upwards by one position.

Moving Press the button to move the order of the list downwards by one position.

Deleting Press the button when in the ‘Edit’ screen to delete the highlighted program
from the list.

Note: You will be asked if you really want to delete the highlighted program.

Scrolling forwards Press the button to scroll one page down the list.

Scrolling backwards Press the button to scroll one page up the list.

42
 Description of the selection buttons 10

Close Press the button to close the Fast Path and Memory programs.

Cancel Press the button to reject the changes made.

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

OK The changes are applied by pressing the button.

43
 Electrotherapy 11

Screenshots of the various therapy

screens
Monostim

Example: Program AB 00 on one channel (I).

Twinstim

Example: Program AB 00 on both channels (I and II).

44
 Electrotherapy 11

Screenshots of the various therapy

screens
Duostim
reciprocating

Duostim
co-contract

Duostim
independent

45
 Electrotherapy 12

12.1 Description of the screen

elements
Note: The ‘Parameter’ and ‘On/Off Time’ buttons turn into control panels once an
electrotherapy program has been selected.

Title bar

The title bar shows the channel mode and the name of the effective current
form.

Status bar

The status bar shows information on the current status of the therapy. If the
therapy is not active, it shows the word ‘Ready’. During therapy, it shows the
word ‘Active’.

Effects

Gives an overview of the associated medical effects of analgesia,

hyperaemia, relaxation and strengthening of the current form.

Note: If the waveform parameters (pulse time or pause) are changed, the effects of
the current form may also change. The window is therefore no longer visible
after a change.

46
 Electrotherapy 12

12.1 Description of the screen

elements
Therapy time

Shows the total therapy time from the After starting therapy the remaining
start of therapy. time is displayed.

Bar graph
of intensity

Shows the currently specified intensity.

In CC mode: In CV mode:
display in mA eff or peak. display in V peak.
(eff = rms)

47
 Electrotherapy 12

12.2 Description of the parameters

button
Parameters

1. Presents the parameters of the current therapy program.

2. Activates ‘Parameters of Current Form’ for modification.

A detailed description can be found in Section 9.4.

1.1 Frequency display

1.2 Graphic view of waveform
1.3 Polarity
1.4 CC / CV
1.5 Galvanic component

Note: Parameters 1.3–1.5 cannot be used with all current forms and are therefore
not always displayed.

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 12

12.2 Description of the parameters

button
1.2 Waveform Graphic view of waveform.

1.3 Polarity Display of polarity:

• only positive
• only negative
• polarity reverses automatically

Note: If the polarity reverses automatically, the first polarity reversal is for 45
seconds (factory setting) or the time set in the configuration menu.

1.4 CC / CV Indication of constant current or constant voltage.

• constant current

• constant voltage

1.5 Galvanic Indication of the galvanic component:

component
• 0%
• 20%
• 50%

49
 Electrotherapy 12

12.3 Description of the On/Off Time

button
On/Off Time active

Indicates that a On/Off Time is activated and shows the parameters of the
effective On/Off Time.

6.0 / 12.0 s

6.0 - rise time and retention time of the On/Off Time phase in seconds
12.0 - pause of the On/Off Time phase in seconds

After activation of the On/Off Time window, the On/Off Time parameters can
be set separately. For a detailed description see Section 10.5.

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

On/Off Time
deactivated

When the On/Off Time is deactivated, the On/Off Time window is shown in
minimised form.

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

Note: If there is no factory setting for a On/Off Time in a program, this window is not
shown.

50
 Electrotherapy 12

12.3 Description of the On/Off Time

button
On/Off Time inactive

When the therapy is inactive, the On/Off Time is shown completely in blue.

On/Off Time active

During therapy, the On/Off Time is shown as an animation showing the On/Off
Time position.

Synchronisation mode Reciprocating

reciprocating

In two-channel mode the alternating reciprocating On/Off Time mode is shown

by the two opposing arrows in the top left corner.

Synchronisation mode Co-contract

Co-contract

In two-channel mode the co-contract On/Off Time mode is shown by the two
parallel arrows in the top left corner.

51
 Electrotherapy 12

12.4 Change current form

parameters
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 Adjustable parameters can be changed by the user here:

form
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 12

12.4 Change current form

parameters

Selecting the The parameters that are to be changed are selected with the
parameters

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 12

12.4 Change current form

parameters
Galvanic Press the
component

arrow keys to reinforce the current form with a galvanic component or to

eliminate the galvanic component.

Switching CC / CV Press the

mode

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 12

12.4 Change current form

parameters
Saving Press the
parameters

button to save the modified parameters.

Cancelling Press the

changes

button to reject changes.

55
 Electrotherapy 12

12.5 Change On/Off Time parameters

Note: If the On/Off Time button is activated during therapy, the therapy will be
interrupted, the intensity returns to zero and the therapy time is set to the
standard value.

Activating When the On/Off Time button is activated, the ‘On/Off-Time Parameters’
On/Off-Time button window is opened.

On/Off-Time
parameters

The On/Off Time parameters can be modified as follows by the user:

Surge rise time: 0 s: surge off
Shortest rise time: 0.5 s
Longest rise time: 60 s
Shortest On-Time: 0s
Longest On-Time: 60 s
Shortest fall time: 0.2 s
Longest fall time: 5s
Shortest Off-Time: 0.2 s
Longest Off-Time: 60 s

56
 Electrotherapy 12

12.5 Change On/Off Time parameters

The duration of the On/Off-Time phase is calculated from the duration of the
rise time, On-Time and down time.

Selecting Select the parameters to be changed using the

parameters

arrow keys.

1. Rise time (1.5 s here)

2. On-Time (4.0 s here)
3. Off-Time (12 s here)

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

Changing parameters Use the

arrow keys to increase or decrease the value within the limits specified in the
On/Off Time parameters definition.

57
 Electrotherapy 12

12.5 Change On/Off Time parameters

Saving Press the
parameters

button to save the modified parameters.

Cancelling Press the

changes

button to reject changes.

58
 Electrotherapy 12

12.6 Description of the screen

elements and the interference button
Interference This parameter window shows the maximum effect.
parameter window 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 Adjustable parameters can be changed by the user here:

form
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 13

Screenshot of the therapy screen

60
 Ultrasound therapy 14

14.1 Description of the screen

elements
Title bar

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

Status bar

The status bar shows information on the current status of the therapy. If the
therapy is not active, it shows the word ‘Ready’. During therapy, it shows the
word ‘Active’.

Parameters

1. Displays data from the connected ultrasound head and the program
parameters.
2. Opens the ‘Parameters’ window.

A detailed description can be found in Section 12.2.

1.1 Ultrasound head and size of ultrasound head

1.2 Operating mode / pulse frequency / duty cycle

61
 Ultrasound therapy 14

14.1 Description of the screen

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

1.2 Operating mode Graphic view of the operating mode

Duty Cycle
Pulse frequency continuous

or

pulsed

Pulsed operating mode showing the pulse ratio (1:3 here) and the pulse
frequency (20 Hz here).

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

In this example: 75% 2.4 MHz

25% 0.8 MHz (800 kHz)

62
 Ultrasound therapy 14

14.1 Description of the screen

elements
Coupling The coupling is shown digitally as a percentage.

Important:
The most beneficial coupling value is 100%.
If the coupling is below the preset value (factory setting 75%), an acoustic
signal sounds and the therapy time is paused.

In this case:
Set a new coupling value and when the coupling is sufficient the therapy will
continue.

Bar graph Shows the current specified intensity.

63
 Ultrasound therapy 14

14.2 Description of the parameter

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

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

64
 Ultrasound therapy 14

14.2 Description of the parameter

button
Selecting the mode Press the two arrow buttons

to select the desired mode.

Modes:
• continuous
• pulsed with duty cycles of 1:2, 1:3, 1:5 and 1:10

Note: The duty cycle of 1:10 only provides comfort heating.

Selecting the Press the two arrow buttons

frequency

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
 Ultrasound therapy 14

14.2 Description of the parameter

button
Saving Press the

button to save the modified parameters.

Cancelling Press the

changes

button to reject changes made.

66
 Ultrasound therapy 14

14.3 Description of the frequency

button
Note: If the Frequency button is activated during therapy, the therapy will be
interrupted, the intensity returns to zero and the therapy time is set to the
standard value.

Adjusting treatment Press the ‘Frequency’ button

depth

to open the Frequency screen.

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

67
 Combined therapy 15

Screenshot of the therapy screen

Note: The buttons and functions on the ‘Combined’ therapy screen correspond
exactly to the therapy screens for ‘Electrotherapy’ and ‘Ultrasound therapy’ as
described in the previous sections.

An extensive description of the therapy screen will not be given here.

68
 Indications menu 16

The Indications menu helps you to select the therapy.

Indications Press the button

to open the Indications menu.

Selecting by body Select a body region by touching a blue circle.

region

69
 Indications menu 16

Selecting by After selecting the desired body region (shoulder in this example) the
indication Indication window opens showing various indications in the shoulder region.

Select the indication by clicking on the relevant row (Pain Management

(Acute) in this example).

70
 Indications menu 16

Therapy information After selecting the detailed indications another window opens showing
detailed therapy information and a suggested program.

Selecting the therapy Press the button

program

to open the therapy screen with the programme.

71
 Saving a modified program 17

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

separately modified and saved.

Note: The procedure for saving is similar for all therapy forms. The save procedure
for an electrotherapy program is described below.

Selecting the
program

Changing the The change is shown in the title bar (AB 00 – modified).
parameters

72
 Saving a modified program 17

Opening the memory Press the button

list

to open the screen to enter the program name.

Naming the Two options are available for naming a program.

program
1. Accept the program name in the input field.
2. Enter a custom program name. If using a custom name, use the keyboard
to enter the program name.

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

73
 Saving a modified program 17

17.1 Fast Path

Saving a program in
Fast Path

Press the button to open Fast Path.

Adding the program

to Fast Path
Press the button
to add the program to Fast Path.

The program is automatically saved in the first free space in the list.

F: Fast Path
00: Program number in the list

74
 Saving a modified program 17

17.2 Memory
Saving a program in
the Memory
Press the button to open the Memory.

Adding the program

to the Memory
Press the button to add the program to the Memory.

The program is automatically saved in the first free space in the list.

S: Memory
00: Program number in the list

75
 Retrieving and editing Fast Path and 18
memory

18.1 Retrieving Fast Path

The individual saved programmes are listed in Fast Path.

From here they can be:

1. retrieved for therapy or

2. edited (sequence changed or deleted).

Selecting Fast Path

Press the button to open Fast Path.

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

76
 Retrieving and editing Fast Path and 18
memory

18.2 Editing Fast Path

Editing Fast Path

Press the button to open the ‘Edit Fast Path’ screen.

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

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

77
 Retrieving and editing Fast Path and 18
memory

18.2 Editing Fast Path

Deleting a program

Pressing the button triggers the security question ‘Delete’.

Press the button to delete the saved program.

Press the button to keep the saved program.

78
 Retrieving and editing Fast Path and 18
memory

18.3 Retrieving and editing memory

Selecting Memory

Press the button to open the Memory.

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

Editing Memory The following steps to edit the Memory correspond exactly to those used to edit
Note: Fast Path that were described in detail in the preceding section.

79
 Explanation of symbols 19

In the Operating Instructions, this symbol stands for danger.

Follow directions in the Operating Instructions at all times.

! In the Operating Instructions this symbol stands for

‘Caution’ with regard to possible damage to property.

Follow operating instructions

Manufacturer

Serial number

Type BF (as per IEC 601-1):

Degree of protection against electric shock.
Use on hearts is prohibited.

The device is Class II (IEC) or double-insulated.

80
 General technical information 20

Soleo SonoStim / Soleo Stim

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

Power consumption max. 60 VA

Protection class II

Mains fuse 2x2AT

Applied part Type BF

Dimensions 12.7 in x 9.2 in x 5.1 in (322 mm x 234 mm x 130 mm)

Weight 4.6 lbs (2.1 kg)

Transport in original packaging only

Operational 50°F to 104°F (+10°C to + 40°C), 30% to 75% rel. humidity,

environment 700–1060 hPa

Storage 50°F to 122°F (+10°C to + 50°C), 10% to 90% rel. humidity,

700–1060 hPa

Regulatory IEC/EN 60601-1

Compliance IEC/EN 60601-1-2
IEC/EN 60601-2-5
IEC/EN 60601-2-10

81
 Specific technical Information 21

21.1 Stimulation current

Monophasic Amplitude: 0-50mA
Phase duration: 200µs-1.5ms
Pause: 0.5ms-10s
Polarity: Positive, negative or alternating

High Voltage Amplitude: 0-180V

Frequency: 0-1667Hz
Polarity: Positive, negative or alternating

Micro current Amplitude: 0-1mA

Frequency: 0.1-1000Hz
Polarity: Positive, negative or alternating

Biphasic rectangular Amplitude: 0-100mA

symmetric Phase duration: 100µs-1ms
Pause: 0.5ms-10s
Frequency: 0-1667Hz
Burst Frequency: 1-200Hz

Middle Frequency Amplitude: 0-100mA

Carrier Frequency: 2000-8000Hz

Premodulated Amplitude: 0-100mA

Carrier Frequency: 2000-8000Hz
Beat Frequency: 1-200Hz
Sweep low frequency: 1-100Hz
Sweep high frequency: 10-200Hz

Interferential Amplitude: 0-100mA

Carrier Frequency: 2000-8000Hz
Beat Frequency: 1-200Hz
Sweep low frequency: 1-60Hz
Sweep high frequency: 30-200Hz

82
 Specific technical Information 21

21.2 Ultrasound
Ultrasound heads

Frequency 0.8 MHz (800 kMHz) and 2.4 MHz

Small ultrasound head 1 cm² , ERA = 1.1 cm² at 0.8 MHz (800 kMHz), 0.5 cm² at 2.4 MHz

Maximum output 1 W at 0.8 MHz (800 kMHz), 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 head5 cm² , ERA = 2.3 cm² at 0.8 MHz (800 kMHz), 2.4 cm² at 2.4 MHz

Maximum output 6.9 W at 0.8 MHz (800 kMHz), 7.1 W at 2.4 MHz

Intensity steps 0.1 to 3 W/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

Note: Duty cycle 1:10 only provides comfort heating

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

83
 Cleaning 22
Disinfection

Housing Clean housing with standard alcohol-free plastic cleaner.

Disinfect housing with standard alcohol-free disinfectant suitable for plastic.

Screen Clean the screen with standard alcohol-free plastic cleaner.

Disinfect the screen with standard alcohol-free disinfectant suitable for plastic.

Ultrasound heads Clean the ultrasound heads with tap water.

Disinfect the ultrasound heads with standard alcohol-free disinfectant suitable

for plastic.

Sponge holders Rinse sponge holders well with water after every treatment.

Disinfect by washing at 95°C or sterilising in an autoclave.

! Do not use cleaning agents containing alcohol.

84
 Electrodes 23

23.1 Use and care

All ordinary electrodes that are used in electrotherapy can be connected to the
Soleoline by using isolated lead clips. Most successful are the disposable
electrodes from Zimmer MedizinSystems. These electrodes are simple, quick,
exact and hygienic.

Plate electrodes and rubber electrodes are also available in addition to the
disposable electrodes for large surface application. In order to avoid placing the
bare plate electrodes directly onto the skin, the electrodes are surrounded by
sponge pockets. The sponge pockets must be kept wet at all times during the
therapy. Lukewarm tap water is most suitable. To attach the sponge pockets,
use the rubber bands. The electrodes need to cling to the body surface with a
slight pressure, however pressure marks should not be left by the rubber
bands.

Electrically, plate electrodes are connected like disposable electrodes, using

the electrode lead clips. The clips are connected to the plate electrodes which
have been previously placed inside the sponge pockets. After the therapy
session, the sponges should be cleaned well with water or with a disinfecting
solution.

Do not place electrodes on skin injuries. Even minor cracks or injuries are likely
to cause burns and the patient will feel the current intensity differently. If this
cannot be avoided, use zinc cream to cover sensitive areas.

85
 Electrodes 23

23.2 Information about the use of

various electrode types
General note Select and apply electrodes with care. In constant current operation, a good,
even skin contact must be ensured. A reduction in the contact area may result
in paraesthesia in patients.

Before starting the treatment, the skin must be inspected and cleaned if
necessary, e.g., if the patient is sweaty or has applied any cream. Inflamed
skin, small wounds or scratches are covered with Vaseline or zinc cream.
Particular caution is also advised for recent scarring.

Disposable Self-adhering disposable electrodes allow comfortable and quick application.

electrodes 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.

Sponge holders and Both rubber and zinc plate electrodes must always have a moist intermediate
sponges layer placed underneath. It is recommended to use sponge holders for rubber
electrodes and sponges, which should be at least 1 to 2 cm thick, for zinc plate
electrodes. Tap water is recommended to moisten the sponges; distilled water
is not suitable as it is a poor conductor.

Unlike the comfortable self-adhesive disposable electrodes, rubber and zinc

plate electrodes must be fixed in place. Velcro or perforated rubber bands are
suitable.

86
 Contents on delivery 24
Accessories

24.1 Soleo SonoStim

Contents on delivery Soleo SonoStim
Item No.

5340 1 Soleo SonoStim device

154 2 electrode cables, incl. 2 red and 2 black alligator clips,
2.90 m long, incl. magnetic clip
4200 1 variable frequency ultrasound head 0.8 and 2.4 MHz, ø 28 mm
65910320 1 storage tray, right
65910310 1 storage tray, left
67250130 1 mains cable
65800410 2 touch pens
65920310 2 test resitances

Accessories
Item No.

65800410 Touch pen

67250130 Mains cable
65910320 Storage tray, right
65910310 Storage tray, left
65920310 Test resistance
Electrotherapy
154 2 electrode cables, incl. 2 red and 2 black alligator clips,
2.90 m long, incl. magnetic clip
68910111 1 pair electrode cables, 2.90 m
31100146 Alligator clip red
31100147 Alligator clip black
16 Disposable electrodes, 135 pairs, small (1 package)
17 Disposable electrodes, 90 pairs, medium (1 package)
18 Disposable electrodes, 45 pairs, large (1 package)
25 Disposable electrodes, 50 pairs, round (1 package)

Ultrasound therapy
4200 Variable frequency ultrasound head 0.8 and 2.4 MHz, ø 5 cm2 (28 mm)
4220 Variable frequency ultrasound head 0.8 and 2.4 MHz, ø 5 cm2 (13 mm)

87
 Contents on delivery 24
Accessories

24.2 Soleo Stim

Contents on delivery Soleo Stim
Item No.

5350 1 Soleo Stim device

154 2 electrode cables, incl. 2 red and 2 black alligator clips,
2.90 m long, incl. magnetic clip
65910320 1 storage tray, right
65910310 1 storage tray, left
67250130 1 mains cable
65800410 2 touch pens
65920310 2 test resitances

Accessories
Item No.
154 2 electrode cables, incl. 2 red and 2 black alligator clips,
2.90 m long, incl. magnetic clip
68910111 1 pair electrode cables, 2.90 m
31100146 Alligator clip red
31100147 Alligator clip black
16 Disposable electrodes, 135 pairs, small (1 package)
17 Disposable electrodes, 90 pairs, medium (1 package)
18 Disposable electrodes, 45 pairs, large (1 package)
25 Disposable electrodes, 50 pairs, round (1 package)
65800410 Touch pen
67250130 Mains cable
65910320 Storage tray, right
65910310 Storage tray, left
65920310 Test resistance

88
 Safety and maintenance 25

Soleo SonoStim / Soleo Stim are produced in accordance with the safety
requirements of IEC 60601-1.

Zimmer MedizinSystems as the manufacturer can be responsible for the safety

and reliability only in the following circumstances:

• if the device is operated from an approved earthed wall socket

• if the device is operated in accordance with the Operating Instructions

• if extensions, reconfigurations or modifications are implemented only by

persons authorised by Zimmer MedizinSystems

• users must ensure that the device is operating correctly and is in good
repair before using it

• before every use check the ultrasound head, cables and connectors for
damage (such as cracks) that could adversely affect the safety of the
device

• the device must be operated by appropriately trained personnel only

• disconnect the device from the power supply immediately if it is exposed to

liquids

• The unit is not designed for use in explosive or inflammable environments

The device does not contain any parts that must be maintained or repaired by
the operator.

89
 Functional test 26

Soleo SonoStim / Soleo Stim runs a self-test that checks all internal
components after it is switched on.

An error message is shown in case of faults.

An extended functional test can also be run in all three operating modes as
described below.

These tests should be run once a month or if there is any doubt about the
operational reliability of the device.

Stimulation current Select program DC 00. Insert test adapter (test Patient).
The display in the bar graph must be completely full at maximum intensity. Run
the test consecutively with both channels.

Ultrasound Select ultrasound head and cover the ultrasound head with gel. The coupling
display must show over 90% at low power and at the start of therapy.
Run the test consecutively using both ultrasound heads.
Then clean ultrasound heads.

90
 Technical safety checks 27

National laws and regulations must be observed when installing and operating
the therapy devices Soleo SonoStim and Soleo Stim.

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

91
 Error messages 28
Troubleshooting
Disposal

Cable check

With stimulation current therapy in continuous current mode:

the patient current circuit is broken.
This message generally indicates failed electrodes, dirty electrode terminals or
a faulty patient fuse. Press OK to clear the message.

Excess current

This refers to an increase above the maximum allowable current. A current

increase in continuous mode generally indicates a fault in the device, while a
current increase in continuous voltage mode may occur because of a change in
the patient resistance (e.g., moist skin).

Press OK to clear the message.

If the error message appears again, contact customer service.

92
 Error messages 28
Troubleshooting
Disposal

No SD card found

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

Insert the card and confirm with OK.

Error The screen shows:

In some cases, the error can be cleared after switching the device off, waiting
five seconds and switching it on again.

If this does not work, contact customer service.

Customer service can be contacted through the head office in Irvine, CA.

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

Head office Zimmer MedizinSystems

25 Mauchly
Suite 300
Irvine, CA 92618
www.zimmerusa.com

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

Emissions tests Compliance Electromagnetic environment – guidance

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

RF emissions CISPR 11 Class B The Soleo SonoStim / Soleo Stim device is

suitable for use in all establishments, including
Harmonic emissions IEC 61000-3-2 Class A domestic establishments and those directly
connected to the public low-voltage power
Voltage fluctuation emissions and flicker Complies
supply network that supplies buildings used for
IEC 61000-3-3 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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 Manufacturer's EMC declaration 29

Guidance and manufacturer's declaration – electromagnetic immunity

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

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

Electrostatic discharge ± 6 kV contact ± 6 kV contact Floors should be wood, concrete or ceramic

(ESD) tile. If floors are covered with synthetic
IEC 61000-4-2 ± 8 kV air ± 8 kV air material, the relative humidity should be at
least 30%.

Electrical fast ± 2 kV for mains power ± 2 kV for mains The quality of the supply voltage should
transient/burst lines power lines correspond to a typical business or hospital
IEC 61000-4-4 environment.
± 1 kV for input/output Not applicable
lines

Surge ± 1 kV differential ± 1 kV differential The quality of the supply voltage should

IEC 6100-4-5 mode mode correspond to a typical business or hospital
environment.
± 2 kV common mode ± 2 kV common
mode

The quality of the supply <5% U T <5% U T Mains power quality should be that of a typical
voltage should correspond (>95% dip in U T for 0.5 (>95% dip in U T for commercial or hospital environment. If the
to a typical business or cycle) 0.5 cycle) user of the Soleo SonoStim / Soleo Stim
hospital environment. requires continued operation during power
40% U T 40% U T mains interruptions, it is recommended that
(>60% dip in U T for 5 (>60% dip in U T for 5 the Soleo SonoStim / Soleo Stim be powered
cycles) cycles) from an uninterruptible power source.

70% U T 70% U T
(>30% dip in U T for 25 (>30% dip in U T for
cycles) 25 cycles)

<5% U T <5% U T
(>95% dip in U T for 5 (>95% dip in U T for 5
sec) sec)

Power frequency (50/60 3 A/m 3 A/m Power frequency magnetic fields should be at
Hz) magnetic field levels characteristic of a typical location in a
IEC 61000-4-8 typical commercial or hospital environment.

Note: U T 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 Stim (stimulation current only)
are: interference-free output of stimulation current and ultrasound with the specified parameters and
interference-free operation of all functions.

Guidance and manufacturer's declaration – electromagnetic immunity

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

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

Conducted 3 V rms 3 V rms Portable and mobile RF communications equipment

RF 150 kHz to 80 MHz 150 kHz to 80 MHz should be used no closer to any part of Soleo SonoStim
IEC / Soleo Stim, including cables, than the recommended
61000-4-6 separation distance calculated from the equation
applicable to the frequency of the transmitter.
Radiated 3 V/m 10 V/m
RF 80 MHz to 2.5 GHz 80 MHz to 2.5 GHz Recommended separation distance:
IEC
61000-4-3 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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 Manufacturer's EMC declaration 29

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 Stim is used exceeds
the applicable RF compliance level above, the device Soleo SonoStim / Soleo Stim 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 Stim.

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 Stim device

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

Rated maximum output power of transmitter Separation distance according to frequency of transmitter
W m

150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
d= 1.17 √P d= 0.35 √P 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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Soleoline
User Manual

USA 10 101 887 UR 0812 I Version 2 I Modifications reserved

Zimmer MedizinSystems
25 Mauchly, Suite 300
Irvine, CA. 92618
800 327 3576
949 727 2154 fax
www.zimmerusa.com
info@zimmerusa.com