Zimmer Soleo Stim, Soleo SonoStim User Manual
User Manual
Soleoline
Soleo SonoStim, Soleo Stim
USA
Soleo SonoStim / Soleo Stim
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
Soleo SonoStim / Soleo Stim
Rear view of device
Fig. 3
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
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
Soleo SonoStim / Soleo Stim
81
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 inte gral 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 t he order of a prac titioner licensed by the la w of
the State in which he/she practices to use or order the use of the device.
1
Indications
1.1 Electrotherapy
1
Indications for use
Indications for Pain
Management
IFC, Premodulated,
Microcurrent,
Biphasic Currents
• Symptomatic relief or management of chronic, intractable pain
• Post-traumatic acute pain
• Post-surgical acute pain
Indications for
Medium Frequency,
Monophasic Currents,
Biphasic Symmetric
Currents and High
Voltage
• Relaxation of muscle spasm
• Increasing local blood circulation
• Prevention or retardati on of disus e atr op hy
• Maintaining or increasing range of motion
• Muscle re-education
• Immediate postsurgical stimulation of calf muscles to prevent venous
thrombosis
2
Indications
1.2 Ultrasound therapy
1
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
3
Contraindications, Cautions
2
Precautionary
Definitions
The precautionary instructions found in the section 2 and 3 and throughout
the manual are indicated by specific symbols. Understand these symbols and
their definitions before operating this equipment. The definition of these
symbols are as follows:
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.
4
Contraindications, Cautions
2.1 Electrotherapy
2
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 pr ac ti ti on er .
• 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 stim ulat or s.
• Potential adverse effects with TENS are skin irritation and electrode
burns.
5
Contraindications, Cautions
2.2 Ultrasound therapy
2
Contraindications
• This device should not be used on any patient with obtuned reflexes or
any area that has significant diminished pain sensitiv it y 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 carr yi ng
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 potenti al pre gna nt pat ient.
• 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
6
Warnings
3.1 General
3
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 procedur es
7
Warnings
3.2 Electrotherapy
3
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, cur rent 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 a ppl ied t rans t hor ac i cal l y in th at th e
introduction of electrical current into the heart may cause cardiac
arrhythmias.
• Stimulation should not be a ppl ied t rans cer ebrally.
• 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.
8
Warnings
3.3 Ultrasound therapy
3
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 alumini um head is eas il y scratc h ed.
• Disinfect the ultrasound head with standard disinfectants after use.
• Use a coupling agent which is intended for ultrasound treatment and has
high electrical conductiv it y.
• Use a coupling agent which is a cleared medical device on the US
market.
9
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
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 Combined therapy.
The compact design saves room in the practice and is highly suited for use in
home visits.
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).
10
Fitting the cables
Starting the system
5.1 Soleo SonoStim / Soleo Stim
5
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
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.
11
Configuration
6.1 General
6
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 scr een ope ns .
Selecting
configuration
Press the button to open the configuration menu.
12
Configuration
6.1 General
6
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 outli ned bel ow.
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.
13
Configuration
6.1 General
6
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.
14
Configuration
6.1 General
6
Sound
To switch the signal sound on and off when activating the control fields:
Press the arrow key to open the dropdown 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.
15
Configuration
6.1 General
6
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 mess age fi eld
to open the screen keyboard to enter a welcome message.
Note:
Press for upper case letters and additional symbols.
16
Configuration
6.1 General
6
Setting defaults
Press the button to reset the unit to the factory default settings.
Version
Press the button to open the window with information about the
current software version.
Press the OK button to close the window.
17
Configuration
6.2 Electrotherapy
6
Electrotherapy
settings
Activate the menu
to open the ‘Electrotherapy configuration’ screen.
The settings required for therapy can be adjusted here.
Time
Option to configure a uniform therapy time of 1 to 60 minutes for all programs.
Use the arrow buttons to adjust time to desired setting.
Polarity cycle
Option to adjust the polarity reversal time from 10 to 120 seconds.
Use the arrow buttons to adjust time to desired setting.
18
Configuration
6.2 Electrotherapy
6
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.
19
Configuration
6.3 Ultrasound therapy
6
Note:
Activation of the ‘Ultrasound Therapy’ menu and the associated settings is
only possible in the Soleo SonoStim version.
Ultrasound therapy
settings
Press the t ab
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%.
20
Configuration
6.3 Ultrasound therapy
6
Units
Option to configure the units for intensity in a bar graph:
Press the arrow
button to open the drop-down menu to select the desired units for power.
The unit is selected by pressing on the appropriate row.
21
Configuration
6.4 Maintenance
6
Updates
Press the t ab
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 passwor d ‘ar m in’ .
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.
22
Soleo SonoStim
Quick operating instructions
7.1 Electrotherapy
7
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
program
There are 3 different programmes available in SonoStim.
- Electrotherapy
- Ultrasound therapy
- Combined t herapy
23
Soleo SonoStim
Quick operating instructions
7.1 Electrotherapy
7
Selecting
electrotherapy
Electrotherapy is selected by pressing on the appropriate row.
The following description refers to the electrotherapy program.
Selecting
current forms group
Select the current forms group by pressing on the appropriate row (here
Neuromuscular Electrical Stimulation (NMES)).
24
Soleo SonoStim
Quick operating instructions
7.1 Electrotherapy
7
Selecting current form
Select the current form by pressing on the appropriate row (here AB 00).
Therapy screen
After selecting the current form, the therapy screen opens automatically for
channel I.
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