Zimmer Soleo Stim User manual

User Manual
Soleoline
Soleo SonoStim, Soleo Stim
User Manual 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 channelII
13 Fuse drawer for mainsfuse
17 Socket for 0.8/2.4 MHzultrasound head
14 On/off switch
18 Socket for electrode cable channelI
15 Socket without function in Soleoline
12
13
15
14
16
17
18

Contents
Soleo SonoStim / Soleo Stim
Front view of device
Selection and controlelements/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 ofthe screen elements
46
12.2
Description ofthe parameter button
48
12.3
Description ofthe On/Offtime button
50
12.4
Change current form parameters
52
12.5
Change On/Off time parameters
56
12.6
Description ofthe screen elementsand the interferencebutton
59
13. Ultrasound therapy – Screenshot of the therapy screen 60
14.
Ultrasound therapy
14.1
Description ofscreen elements
61
14.2
Description ofthe parameter button
64
14.3
Description ofthe 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 andediting 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 ofvarious 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 SoleoSonoStim, Soleo Stim.
These Operating Instructions are an integralpart of the device.
They must be stored with the device andkept accessibleat 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 byor on the order of apractitioner licensed by the law of
the State inwhichhe/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 localblood circulation
•Prevention or retardation of disuse atrophy
•Maintaining or increasing range ofmotion
•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 ofpain, muscle spasms and joint contractures that may be
associated with:
oAdhesive capsulitis
oBursitis with slight calcification
oMyositis
oSoft tissue injuries
oShortened tendons due to past injuries and scar tissues
•Relief ofpain, muscle spasms and joint contracturesresulting from:
oCapsular tightness
oCapsular scarring

3
Contraindications, Cautions
2
Precautionary
Definitions
The precautionary instructions found in the section 2 and 3and throughout
the manualare indicated byspecific symbols. Understand these symbolsand
their definitions before operating this equipment. The definition of these
symbols are as follows:
Caution
Text with “Caution”indicator will explain possible safetyinfractionsthat could
have the potential to cause minor to moderate injury or damage to equipment.
Warning
Text with “Warning”indicatorwill explain possible safety infractionsthat will
potentially cause serious injury and equipment damage.

4
Contraindications, Cautions
2.1 Electrotherapy
2
Contraindications
•Poweredmuscle stimulators should not be usedon 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 forpatients with suspected or diagnosed heart
problems.
•Cautionshould be used forpatients with suspectedor diagnosed
epilepsy.
•Cautionshould be used in the presence ofthe following:
oWhen there isa tendency to hemorrhage following acute trauma or
fracture;
oFollowing recent surgical procedures when muscle contraction may
disrupt the healing process;
oOver the menstruating or pregnant uterus; and
•Over areasof the skin which lacknormal sensation.
•This device should notbe used forsymptomatic localpain reliefunless
etiologyis established orunless pain syndrome hasbeen 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 electricalstimulation or electrical conductive medium. The irritation
can usually be reducedby using an alternate conductive medium, or
alternate electrode placement.
•Electrode placement and stimulation settings should bebased 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 effectivenessof 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 beneaththe electrodes have been reported with
the use of powered muscle stimulators.
•Potentialadverse effects with TENS are skin irritation and electrode
burns.

5
Contraindications, Cautions
2.2 Ultrasound therapy
2
Contraindications
•This device should notbe used on any patient with obtuned reflexesor
any area that has significant diminished pain sensitivity or heat
sensitivity.
•This device should notbe used forsymptomatic localpain reliefunless
etiologyis established orunless pain syndrome hasbeen diagnosed.
•This device should notbe used overor in a region of tumor/malignancy.
•This device should not be used when open woundsare present in the
treatment area.
•This device should notbe used directly over theportion of the spinal
cord that is no longerprotected by bone following a laminectomy.
•This device should notbe 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 notbe used overor near bone growth centers until
bone growth is complete.
•This device should notbe used overa healing fracture.
•This device should notbe used overthe thoracic area of anypatient that
has a cardiac pacemaker of any kind.
•This device should notbe used overthe reproductiveorgans.
•This device should notbe used overor appliedto the eye.
•This device should notbe used overthe abdomen, pelvic orlumbar
regions of pregnant or potential pregnant patient.
•This device should notbe used on ischemictissues in individualswith
vasculardisease where theblood supply wouldbe unable to follow the
increase in metabolic demand and tissue necrosis might result.
Metal implants and endoprostheses
There areno longer any concerns about dynamic ultrasound application in
low doses.
Cautions
•Before each use, inspectthe ultrasound heads forcracks,which may
allow the ingress of conductive fluid
•Over an area of the spinal cord following:
oLaminectomy, i.e., when major covering tissueshave been
removed
oOver anesthetic areas
oOn 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 thelaw of theState in which he/she practices to use
or order the use of the device.
Do not usethe device in wet rooms (hydrotherapy) or balneotherapy rooms.
Do not leave patientsunattended during treatment.
This device isexclusivelyfor use byqualified medical personnel. This device
may causemalfunctioning in or may interfere with the operation ofdevices in
its vicinity. It maybe necessaryto take action toavoid interference such as
using a different alignment,moving the device orshielding it.
Make certain that theunit is grounded byconnecting only to agrounded
electrical service receptacle conforming to theapplicable national and local
electrical codes.
Before administering any treatment to a patient you should become
acquainted with the operating proceduresfor each mode oftreatment
available, as well as the indications, contraindications, warning and
precautions. Consultother resources foradditionalinformation 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. Donot bring the ultrasoundhead into contactwith sharp orpointed
objects as the aluminium head is easily scratched.
Handle,clean and disposeof components andaccessories thathave come in
contact with bodyfluids according to national, local and facility rules,
regulations and procedures

7
Warnings
3.2 Electrotherapy
3
Electrotherapy
•Do not conduct electrotherapy treatment on patients with implants or any
other implanted electronic device unless the riskhas been assessed and
found negligible.
•Patientsmust 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 inthe vicinity (e.g., within1 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 currentdensity for currents that couldcause
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 mayincrease the
risk of cardiac fibrillation.
•When using different electrodes,note that a smallerelectrode surface
area may result in a highercurrent density.
•The long-term effects of chronic electrical stimulation are unknown.
•Stimulation should notbe applied overthe carotid sinusnerves,
particularly in patients with a known sensitivity to the carotid sinusreflex.
•Stimulation should not be applied over the neck or mouth. Severe
spasm of the laryngeal and pharyngeal muscles may occur and the
contractions maybe strongenough 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 maycause cardiac
arrhythmias.
•Stimulation should not be applied transcerebrally.
•Stimulation should not beappliedover swollen, infected, orinflamed
areas or skin eruptions,e.g., phlebitis, Thrombophlebitis, varicose veins,
etc.
•Stimulation should notbe 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 inhazardous exposureto
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.
•Patientsmust not be connected to a radio-frequency surgical device at
the same time. This may result in burns.
•Operation of the ultrasounddevice in thevicinity (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 afteruse.
•Use a coupling agent which is intended forultrasound treatment and has
high electrical conductivity.
•Use a coupling agent which is a cleared medical device on the US
market.

9
Soleoline – Summary
4
What is Soleoline?
An ultramodernand innovative range of products with 3different devices
available.
SoleoSonoStim
An ultramodernand innovative combination device for electrotherapyand
ultrasound therapy.
SoleoStim
An ultramodernand innovative electrotherapy device.
Soleo Sono
An ultramodernand innovative ultrasoundtherapy device.
Note:
The operation of SoleoSono is described in a separateset of instructions.
What does the
Soleoline do?
Output of monophasic, biphasic and medium frequencycurrents for nerve
stimulation andmuscle therapy for mono channeland dualchannel 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 startconfigurationand clear,simple menu navigation
make operation ofthe device easyand comfortable for users.
The combination of electrotherapyand ultrasound therapy in a single system
enables the use of the established Combined therapy.
The compact design savesroom in the practice and ishighly suited for use in
home visits.
Innovations in
Soleoline?
SonoSwing, the innovation in the field ofultrasoundtherapy:
•a singleultrasound head with two frequencies0,8MHz and 2,4 MHz
•freely selectable penetration depths using percentage adjustment of the
frequency ratios.
Note:
The device should onlybe used bymedical 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 offitting the cables refersto the operation ofSoleo
SonoStim / Soleo Stim.
Note:
There aregreen 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 theappropriate socket (18).
Plug theelectrode cable for channel IIinto the appropriate socket (16).
Attach the redalligator clip to the red connector onthe electrode cable.
Attach the blackalligatorclip 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 onthe device using the rocker switch (14).
Note:
All buttons, menusand submenus are activated directlyon the screen by
touching it orusing the touch pen.

11
Configuration
6.1 General
6
Note:
The following descriptions always refer totherapyusing a single channel and
are based on the factory default settings.
Note:
Changes to the default settings can only bemade fromthe 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.

12
Configuration
6.1 General
6
Configuration menu
In the configurationmenu the factory settings can be changedand individually
set. After activation of the configuration menu the ‘Select configuration’ screen
is active.
Saving settings
Press the button to save the newsettings.
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 toselect 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 toselect 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 toselect the start screen.
The selection is made by pressing on the appropriate row.

14
Configuration
6.1 General
6
Sound
To switch the signal soundon and off when activating the control fields:
Press the arrow key to open the drop-
down menu to switch sound onand off.
The selection is made by pressing on the appropriate row.
Volume
Option toadjust the volumein stepsfrom 1 to 4:
Press the arrow buttons to
open the windowto adjust the volume.
The volumeis adjusted using botharrow keys.
Brightness
Option toadjust the screen brightness in stepsfrom 0 to 10:
Press the arrow buttons to adjust the screen brightness.