Zimmer Soleo Sono User manual

Instructions for Use
Soleoline
Soleo Sono
EN

Illustrations
Soleo Sono
Front of the device
Fig. 1
Device and
operating
elements
1
Intensity regulator channel I
2
Controller for frequency component
3
Display
4
Slot for SD card
5
Transducer
6
Holder for transducer (optional)
1
2
3
4
5
6

Illustrations
Soleo Sono
Display views / navigation menus
Fig. 2
Display view
7
Status bar
8
Buttons on the screen
9
Navigation menus
Fig. 3
Navigation menu
Description of the
functions
(A) Back
Moves one step back
(B) Therapy
Switches to therapy area
(C) Favourites
Switches to Favourites
(D) Programmes
Switches to the programmelist
(E) Protocols
Switches to Protocols
(F) Scroll backwards
Goes back one page
(G) Scroll forwards
Goes forward one page
9
8
7
G
E
D
C
B
A
F

Illustrations
Soleo Sono
Rear of the device / switches and ports
Fig. 4
Switches and
ports
11
On/off switch
12
Holder for mains fuse
13
Connection for power cable
16
Port for transducer 0.8 / 2.4 MHz
18
Identification plate
Note: The ports (14*), (15*) and (17*) do not have any function for Soleo Sono.
11
12
(14*)
13
(15*)
16
(17*)
18

Illustrations
Soleo Sono
Transducers
Fig. 5
Transducer, large Transducer, small

Explanation of symbols
In the instructionsfor use this symbol indicates Danger.
Caution
!
In the instructionsfor use this symbol indicates "Caution“with regardto
possible damage of the device.
Applied parttype BF
Follow instructions for use.
Instructions for use
Serial number
Item number
Manufacturer
Date of manufacture
This symbol points out hazardous areas on the device.
Interval operation

Content
Illustrations
Soleo Sono
Front of the device
Display views / navigation menus
Rear of the device / Switches and ports
Transducers
Explanation of symbols
Page
1Indications / Contraindications
1.1 Indications
1.2 Contraindications
1
2
2
Side effects
3
3
Application information
3.1 General
3.2 Ultrasound
4
5
4
Warnings
6
5
Soleoline – in brief 7
6
Intended use 8
7 Device set-up
7.1 Mounting the cables 9
8
Settings
8.1 General
8.2 Ultrasound therapy
8.3 Maintenance
10
12
13

Content
9
Operation instructions
9.1 Ultrasound therapy
9.2 Displays / buttons
9.3 Water bath treatment
9.4 SD card
9.5 Protocols
9.6 Lists offavourites - Retrieve programmes, edit list
14
17
18
19
20
22
10
Technical information
10.1 General
10.2 Ultrasound
25
26
11
Cleaning, disinfection 27
12
CE mark / manufacturer 28
13
Scope of delivery, accessories
29
14
Device combinations 30
15
Safety and maintenance 31
16
Functional test 32
17
Safety check / metrological control 33
18
Error messages, troubleshooting, disposal 34
19
Manufacturer's EMC declaration 35

Content
Valid for the device Soleo Sono (NG).
These instructions foruse are an integral part of the device.
They mustbe stored with the device and keptaccessible atall
times for anyone authorisedto operate this device.
The instructions for use are valid as of October 2016.

Indications / Contraindications
1.1 Indications
1
Page 1
Indications from
orthopaedics,
surgery,
traumatology,
rheumatology
•Vertebrogenicpain syndrome, e.g. cervical syndrome
•Ankylosing spondylitis (only during the inflammation-free interval)
•Joint diseases
•Rheumatoid arthritis (if heattreatment is indicated)
•Osteoarthritis
•Periarthropathy
•Epicondylopathy
•Chronic tendinitis, periostitis, heel spur
•Achillodynia
•Scars, contractures, Dupuytren's contracture
•Posttraumatic discomfort
•Fractures (especially with delayed callus formation)
Other indications
•Bronchial asthma
•Rhinopathy
•Persistent discomfort of the cervical spine following whiplash with
repetitive blockages
•Headaches
•Earaches
•Postherpetic neuralgia
•Functional disorders of the stomach and duodenum
•Chronic pelvic pain
•Functional discomfort of the lesser pelvis

Indications / Contraindications
1.2 Contraindications
1
Page 2
General
contraindications
•Unclear pain symptoms
•Diseasesfor which heatshouldnot beused, such as acute inflammatory
diseases
•Diseasesin which mechanicalinfluences are contraindicated, such as
phlebothrombosis
•Limited blood flow
•Suspected cardiovascular diseases
•Haemorrhagic diathesis
•Do not treat cervically higher than C3
•Ultrasound treatment of parenchymatous or heat-sensitive organs
(testes, eyes, gravid uterus, liver, kidney, etc.)
•Anaesthetised areas of skin
•Abnormal temperature perception
•Following treatmentwith ionising radiation
•Epiphyseal plates
•Tumours
•Electronic pacemakers
•Use on or near open wounds
•Limited reflexes orpain sensitivity
•Use on the abdominal, pelvic or lumbar regions during pregnancy or
suspected pregnancy
Metal implants and endoprostheses
Nowadays there are no more concerns against the use of dynamic, low-dose
ultrasound.

Side effects
2
Page 3
Side effects of
ultrasound therapy
No side effects are known if used correctly.

Application information
3.1 General
3
Page 4
Priorto using the device ona patient, the user should become familiarwith the
instructions for use and individual treatment methods to be used as well as the
indications / contraindications, warnings and application information. Additional
sources of information about the ultrasound therapy should be followed.
These instructions for use must always be stored with the device and kept
accessible at all times for anyone authorised to operate this device.
The complete medical systemis suitable for use in the vicinityof the patient.
Caution
!
To avoidthe risk of electricshock, the plug must be disconnected fromthe
power supply before performing any cleaning or maintenance activities.
Caution
!
Before use, ensure that the device is powered via a properlygrounded mains
socket (electrical installation according to DIN VDE 0100 Part 710). The device
must only be operated with the supplied power cable. The powercable must
be protected against mechanical stress.
Caution
!
Magneticand electrical fields canaffect the function ofthe device. For this
reason, do not operate the device in the vicinity of devices which generate
strong electromagnetic fields (X-ray or diathermy equipment, MRI machines).
Please keep a safe distance of several meters.
Caution
!
The device is not suitable for use in areas with an explosive, flammable or
combustive environment.
Caution
!
During use, the device is to be located in a positionallowing directaccess to
the device´s central mains supply so that it can be disconnected from the
mains atany time.
Caution
!
Inspect the device before use. If thereis any damage,it must not be used.
Caution
!
Only accessories provided by Zimmer MedizinSysteme GmbHmust be used.
Caution
!
The device may cause malfunctionsor may interfere with the operation of
equipment in the vicinity. It may be necessary to take appropriate remedial
action, such as realignment, re-arrangement of the device or install shielding.
Caution
!
During the service life of the device, no changesmay bemade to the device or
medical system.
Caution
!
To safely disconnect the device from the power supply, pull the mains plug out
of the housing socket oroutlet.

Application information
3.2 Ultrasound
3
Page 5
Handletransducergently;rough handling can alterits characteristics. Do not
allow sharp or pointed objects to come into contact with theultrasound
transducer since thealuminium head can be easily scratched.
The use ofcoupling agents other than the special SonoPlus ultrasound gel can
damage the transducer.
Disinfect transducer after use with conventional equipmentdisinfectants.
Inspectthe ultrasound transducer for damage before each use. If there is any
damage, the ultrasoundtransducer must not be used.
Caution
!
If the transducer is regularly used in a water bath, measures which protect the
user must be taken. All user body parts submerged in water must be protected
through appropriate measures. Appropriate protectivemeasures include what
is knownas "aerated clothing." This can be, for example: neoprene gloves or
latex over cotton gloves.

Warnings
4
Page 6
This device is intended tobe used exclusively by medical professionals.
The use ofthe device out ofthe settings orapplicationsspecified in the
instructionsfor use may lead to hazard bythe uncontrolled emission of
ultrasound energy.
The patient must notbe leftunattended during therapy.
Any treatment instructions regarding treatment location, duration and intensity
require medical knowledgeand should be given byauthorised physicians,
therapists and health paraprofessionals. These instructions mustbe followed.
Use in wet areasis notpermitted and may in case ofnon-compliance lead to
considerabledamage and endanger both the patient and the user.
Dispose of the packaging material properly. Makesure that it isnot accessible
to children.
On patients with implants oran implanted electronic device do not conduct
treatment before the risk has been assessed and found negligible.
Patients may not be connected to ahigh-frequency surgical device at the
same time. This can lead toburns.

Soleoline in brief
5
Page 7
What is Soleoline?
An ultramodern, innovativeproduct line featuring 3 different device variants.
Soleo Sono
An ultramodern, innovativeultrasound therapy device.
Soleo SonoStim
An ultramodern, innovativecombination device for electro- and ultrasound
therapy with the option of additionally using VacoS.
Soleo Galva
An ultramodern, innovativeelectrotherapydevice with the option of
additionally using VacoS.
Note:
The operation of Soleo SonoStim and Soleo Galva is described in separate
instructions for use.
What are the
features of
Soleoline?
A modern, easy-to-read colour display showing therapy-related parameters
as well as modern touch operation.Individual program start adjustment and
clear, simple menus offer the user maximum convenience.
The small design enables space-saving work in anoffice and isideally suited
for use during house calls.
What does Soleo
Sono do?
The device emitstherapeuticultrasound via a modern sliding frequency
transducer.
Innovations in Soleo
Sono?
SonoSwing, the innovation in the field ofultrasound therapy:
•a transducer with two frequencies
•freely selectable depth of penetration through the adjustability of the
frequency components by percentage.
Note:
The application of the device is reserved for medical professionals (such as
physicians, therapists and health paraprofessionals).

Intended use
6
Page 8
The Soleoline product line includes3 different device variants:
Soleo Sono
Ultrasound therapydevice for treatment with therapeutic ultrasound.
Soleo SonoStim
Combination device for therapeuticultrasound therapyand electrotherapy
with the option of additionally using VacoS.
Soleo Galva
Electrotherapy device with the option of additionally using VacoS.

Device set-up
7.1 Mounting the cables
7
Page 9
Note:
The cables have coloured arrows to aid with orientation for proper
connection with the device.
Ultrasound therapy
Connect the transducerto the providedport (16).
Connect power
cable
Connectthe power cable tothe provided port (13) and connect the cable to
the mains.
Note:
The device mayonly be connected to power outlets with a protective contact
Switching device on
The device is switched on using the toggleswitch (11).
Switching device off
The device is switched off using the toggleswitch (11).
To fully (all poles) disconnect the device from the mains, the power cable
must be disconnected.
Caution
!
All cables must be protected from pinching or other mechanical damage.
Note:
All buttons, menus and sub-menuscan be activated directlyon the screen
with finger pressure.

Settings
8.1 General
8
Page 10
Note:
The following descriptionsrefer tothe default factory settings.
Note:
Changes to the default settings can only be made fromthe start-up screen.
Start-up screen
After the device has been switched on and the self-testperformed, the start-
up screen opens.
Note:
(1) switches immediatelyto the therapy screen.
Configuration menu
Factorysettingscan be changed and individuallyadjusted in the
configuration menu.
Select configuration
(2) opens the screen "Configuration".
2
1

Settings
8.1 General
8
Page 11
The setting optionsare described below.
The default settingsare pre-programmed in the factory as shown on the
screen.
(1) Start-up settings
Options to individually select the start-up settings.
The selection ismadedirectly in thecorresponding line.
(2) Language
Language selection.
The selection ismadedirectly in thecorresponding line.
(3) Greeting
Activation (3)opens a windowwith an alphabetical keyboard toenter an
individual greeting text inthe start-up screen.
(4) Cancel
Activation (4) stops the process.
(5) OK
Activation (5) saves changes made and switches to the start-up screen.
(6) Version
Activation (6)opens a windowwith information on the current software
version.
(7) Load default
Activation (7) restores the factory default settings.
(8) Sounds
Signal sounds can be switched onand off.
(9) Colour scheme
Activation (9)switchesbetween a bright ora dark screen background.
(10) Screen saver
The setting option for indicating the pointat which the screen saveris
activated.
(11) Brightness
The brightness can be adjusted using the two arrowbuttons.
(12) Volume
The volume can be adjusted using the two arrow buttons.
10
12
3
11
4
6
7
8
2
1
5
9
13