Zimmer Soleo Sono User manual

Instructions for Use
Soleoline
Soleo Sono
EN

Explanation of Symbols
Soleo Sono
Front panel
Fig. 1
Device and
operating
elements
1
Intensity controller channel I
2
Controller for frequency portion
3
Tray mount for ultrasound head
4
Display
5
Touch pen in holder
6
Slot for SD card
1
2
3
4
5
3
6

Explanation of Symbols
Soleo Sono
Display/ Navigation bars
Fig. 2
Displays
7
Status bar
8
Buttons on the screen
9
Title bar
10
Navigation bars
Fig. 3
Navigation bar
Description of
functions
(A)
Back
Moves back one step
(B)
Memory
Switches to the memory area
(C)
Indications
Switches to theindication menu
(D)
Programs
Switches to the program list
(E)
Favourites
Switches to the favouritesarea
(F)
Scroll backwards
Moves back one page
(G)
Scroll forwards
Moves forwards one page
F
E
D
C
B
A
G
9
10
8
7
10

Explanation of Symbols
Soleo Sono
Rear Panel/ Switches and Connector Sockets
Fig. 4
Switches and
connector sockets
11
On/off switch
12
Holder for mains fuse
13
Connection for mains cable
16
Connector for ultrasound head 0.8 / 2.4 MHz
18
Label
Note: For Soleo Sono the sockets (14 *), (15 *) and (17 *) have no function.
11
12
(14*)
13
(15*)
16
(17*)
18

Explanation of Symbols
Soleo Sono
Ultrasound heads
Fig. 5
Ultrasound head, large Ultrasound head, small

Explanation of Symbols
In the instructions foruse, this symbol indicates “Danger”.
Caution!
In the instructions for use, this symbol represents "Caution" with regard to damage of
the device.
Device Type BF
Follow the instructions for use
Instructions for Use
Serial number
Item number
Manufacturer
Date of manufacture
This symbol indicates danger areas on the machine.
Interval operation

Contents
Explanation of Symbols
Soleo Sono
Front panel
Display/ Navigation bars
Rear panel / Switches and connector sockets
Ultrasound heads
Explanation of Symbols
Page
1
Indications / Contraindications 1
2Side Effects 3
3Application Information
3.1 General
3.2 Ultrasound heads 4
5
4 Warnings 6
5 Soleoline – in brief 7
6 Intended Use 8
77 Device Set up
7.1 Installation of Cables 9
8 Basic Settings
8.1 General
8.2 Ultrasound Therapy
8.3 Maintenance
10
13
14
9
Operating Instructions
9.1 Ultrasound therapy
9.2 Displays/Buttons
9.3 Water Bath Treatment
9.4 SD Card
9.5 Indication Menu
9.6 Storing Programs
9.7 Run Programs / EditingLists
15
18
19
20
22
23
25

Contents
10 Technical Information
10.1 General
10.2 Ultrasound 27 28
11 Cleaning / Disinfection 29
12 CE mark / manufacturer 30
13 Scope of Delivery, Accessories 31
14 Device Combinations 32
15 Safety and Maintenance 33
16 Function Test 34
17 Legal Notices 35
18 Error Message, Troubleshooting, Disposal 36
19 37Manufacturer's EMC Declaration
Valid for Soleo Sono.
These instructionsfor use are an integral part ofthe device.
It must be stored with the device and kept accessable atalltimes for
anyone to operate this device.
Information as of:August 2016

Indications / Contraindications
1.1 Indications
1
Page 1
Indications from
orthopaedics, surgery,
traumatology,
rheumatology
•Spinal painsyndromes, e.g.cervical spinesyndrome
•Ankylosing spondylitis (only in inflammation-free intervals)
•Joint disorders
•Rheumatoid arthritis (if heat treatment is indicated)
•Arthrosis
•Periarthropathies
•Epicondylopathy
•Tendopathies, periostosis, calcaneal spurs
•Achillodynia
•Scars, contractures, Dupuytren's contracture
•Posttraumatic arthritis
•Fractures (particularly in cases ofdelayed callusformation)
Other indications
•Bronchial asthma
•Rhinopathy
•Persistent symptoms of the cervical spine after whiplash injury with recurrent
blockages
•Headache
•Earache
•Post herpetic neuralgia
•Functional disorders of thestomach and duodenum
•Pelvic pain
•Functional disorders of the pelvis

Indications / Contraindications
1.2 Contraindications
1
Page 2
General
Contraindications
•Vague pain symptoms
•Diseases whereheat should not be used, forexample, acute inflammatory
diseases
•Diseases where mechanical impacts are contraindicated, e.g. deep vein
thrombosis,
•Restricted blood flow
•Suspected diseases of the cardiovascular system
•Haemorrhagic diatheses
•Cervical vertebrae – do not use ultrasound higherthan C 3
•Ultrasound treatment of parenchymatous or heat-sensitive organs (testes, eyes,
gravid uterus, liver, kidneys etc.)
•Anaesthetised skin areas
•Temperature sensitivity disorders
•After treatment with ionizing radiation
•Epiphyseal plates
•Tumours
•Electronic pacemakers
•Application on orin the vicinity of open wounds
•Impaired reflexes or pain sensitivity
•Application to the abdomen, pelvis, or lumbar area whenpregnant or presumed
pregnant
Metal implants and endoprostheses
Dynamic ultrasound radiation in low dosage is nowadays no longer a matter for
concern.

Side Effects
2
Page 3
Side effects of
ultrasound therapy
If used correctly, no sideeffects are known.

Application Information
3.1 General
3
Page 4
Prior to the application of the device to the patient, the user should become
acquainted with the operating instructions or the individual treatment methods and
also with the indications /contraindications, warnings and directions for use.
Additional sources of information on ultrasound therapy should also be takeninto
consideration.
This user manualshould always bekept with the device to enable the persons
charged with theoperation of the device to access it atany time.
Caution
!
To avoid the risk of electric shock, the device must be disconnectedfrom the mains
supply before performing anymaintenance or cleaning activities.
Caution
!
Before use, ensure that the device is powered via a properly earthed plug with a
grounded outlet(electrical installation according to DIN VDE 0100 Part 710). The
device must only be operated with the supplied powercord. The power cord must be
protected against mechanical stress.
Caution
!
Magnetic and electric fields can influence the function of thedevice. Therefore, the
device must notbe operated in the vicinityof devices that generatestrong
electromagnetic fields (X-rayor diathermy devices, MRI scanners). Please keep a
safe distance of several metres.
Caution
!
The device is not suitable foruse in areas with an explosive, combustible or
combustion-promoting atmosphere.
Caution
!
During use, the device must be placed in such a way that direct access to the
device's central power supply is possible, so that it can be disconnected from the
mains at any time.
Inspect the device before use. If damaged, it must notbe used.
Caution
!
Only accessories providedby Zimmer MedizinSysteme GmbH are to be used and no
other devices must be connected.
Caution
!
The device maycause malfunctions or may interfere with the operation of equipment
in the vicinity. It may be necessary to take appropriate remedial action, such as the
realignment or re-arrangementof the device or the shield.
Caution
!
No change to thedevice or the medical system may be carried out during the product
life of the device.
The entire medical system is suitable for application in the patient environment.
Caution
!
To safely disconnect the unit from the mains supply, remove the mains plug from the
socket housing or socket.

Application Information
3.2 Ultrasound
3
Page 5
Handle the ultrasound head carefully, as rough handling can alter its properties. Do
not bring the ultrasound head into contact with sharp orpointed objects, as the
aluminium head is susceptible to scratching.
The use of couplant other than the special Sono plusultrasound gel candamage the
ultrasound head.
Disinfect the ultrasound head after use, using commercially available equipment
disinfectants.
Inspect the ultrasound head for damage prior to each use. If damaged, it must not be
used.
Caution
!
In the event of regular use of the ultrasound head in the water bath, the user must
take protection measures. Allbody parts of the user immersed in the water must be
protected by appropriate measures. Suitable protective measures are so-called
"aerated clothes".
This can be neoprene gloves or latex over wool gloves.

Warnings
4
Page 6
This productis intended for use by medical professionals only.
Users of the device must be trained in the correct use of thesystem and must
possess the appropriate skills.
The use of this product with settings or for applications otherthan those specifiedin
the user manual may lead tohazards resulting from the uncontrolled release of
ultrasonic energy.
The patient must not be left unattended during therapy.
Treatment instructions regarding the treatment location, duration and intensity of
treatment require medical knowledge andmay only be issued by licensed physicians,
therapists and members of theauxiliary medicalprofessions. It is imperativethat
these instructions are followed.
Use in wet areas is not permitted and non-compliancemay lead to considerable
damage and endanger both the patient and the user.
Dispose of thepackaging material correctly. Keep out of reach of children.
In the case of patients with implants or with an implanted electronic device, treatment
may only be performed after clarification that no risk is involved.
The simultaneous connection of the patient to a high-frequency surgical device is not
permitted. This can lead to burns.

Soleoline – in brief
5
Page 7
What is Soleoline?
An ultra-modern innovative product line that provides 3 different device variants.
Soleo Sono
A cutting-edge, innovative ultrasound therapy device.
Soleo SonoStim
A state of the art,innovative combination device forelectrotherapy and ultrasound
therapy, with theoption of theadditional use ofa vacuum unit.
Soleo Galva
An ultra-modern,innovative electrical stimulator with the possibility to additionally
use a vacuum unit.
Note:
The operation ofSoleo SonoStim and Soleo Galva is described in a separate
instruction for use.
Why use Soleoline?
A modern,clearly arrangedcolour display thatprovides all therapy-related
parameters, as well as modern touch operation.
Customisable program start-up settings and a clear,simple menu offer maximum
convenience for the user.
The compact design allowsspace-saving work in the practice room and is ideally
suited for use during home visits.
What is offered by
Soleo Sono
The delivery of therapeutic ultrasoundvia a modern sliding frequency ultrasound
head.
Innovations in
Soleo Sono?
SonoSwing, the innovation inthe field of ultrasound therapy:
•an ultrasoundhead with two frequencies
•freely adjustable penetrationdepth by means of the percentage adjustment of
the frequency components.
Note:
The device is only intended tobe used by medical professionals (e.g. physicians,
therapists, members of paramedical and trained medical assistants).

Intended Use
6
Page 8
The Soleoline product range includes 3 different deviceversions:
Soleo Sono
Ultrasound therapy device for treatmentwith therapeutic ultrasound.
Soleo SonoStim
Combination device for ultrasonic therapeutic treatment andelectrotherapy, with the
option of the additional useof a vacuum unit.
Soleo Galva
A device for electrotherapy, with the option of the additional use of avacuum unit.

7 Device Set up
7.1 Installation of Cables
7
Page 9
Note:
There are coloured arrowslocated on the cablesas a guidefor proper connection
to the device.
Ultrasound therapy
Connect the ultrasound headto the appropriate socket (16).
Connect the mains
cable
Connect the mains cable to the appropriate socket (13) and connect the cable to
the mains.
Note:
The device mayonly be connected topower outlets with a protective contact.
Switch the device on
The device isswitched on via the toggle switch (11).
Switch the device off
The device isswitched off via the toggle switch (11).
To completely disconnect thedevice (all-phase) from the network, remove the
power cord.
Caution
!
All cables must be protected against jamming or other mechanical damage.
Note:
All of the buttons, menus and sub-menus can beactivated directlyon the screen
using your finger ora touch pen.

Basic Settings
8.1 General
8
Page 10
Note:
The following descriptions arebased on the default settings.
Note:
Changes to the basic settings can only be made from the start up screen.
Start up Screen
Once the device has been switched on and the self-test performed, the start up
screen opens.
Selecting
configuration
Pressing button opens "select configuration".
Configuration menu
In the configuration menu, thefactory settingscan be changed and adjusted
individually. After activating the configuration menu, the "configuration selection"
screen becomes active.
Settings General
The settings options are shown below.
By default, the factory settings are pre-programmed as shown in the screen.

Basic Settings
8.1 General
8
Page 11
Language
Selecting the language
The selection is made directly in thecorresponding row.
Program start up
settings
Adjustment of the programstart up settings.
The selection is made directly in thecorresponding row.
Startup screens
Choice of two start up screens.
The selection is made directly in thecorresponding row.
Sounds
Switching the signal tones on and off.
The selection is made directly in thecorresponding row.
Volume
Adjustment of the volume from1 to 4.
The adjustmentis made usingthe two arrow keys.