Zimmer Soleo SonoStim User manual

Instructions for Use
Soleoline
Soleo SonoStim, Soleo Galva, Soleo VacoS
EN
Instructions for use Soleo SonoStim, Soleo Galva, Soleo VacoS

Explanation of Symbols
Soleo SonoStim / Soleo Galva
Front panel
Fig. 1
Device and
operating
elements
1
Intensity controller channel I
2
Intensity controller channel II
3
Alligator clips clipping options
4
Tray mount for ultrasound head
5
Display
6
Touch pen in holder
7
Slot for SD card
1
2
3
4
5
6
3
4
7

Explanation of Symbols
Soleo SonoStim / Soleo Galva
Display/ Navigation bars
Fig. 2
Displays
8
Status bar
9
Buttons on the screen
10
Title bar
11
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)
Programmes
Switches to the programme list
(E)
Favourites
Switches to the favourites area
(F)
Scroll backwards
Moves back one page
(G)
Scroll forwards
Moves forwards one page
10
11
9
8
11
G
E
D
C
B
A
F

Explanation of Symbols
Soleo SonoStim / Soleo Galva
Rear Panel/Switches and Connector Sockets
Fig. 4
Switches and
connector sockets
12
On/off switch
13
Holder for mains fuse
14
Connection for mains cable
16
Socket for electrode cable channel II
17
Connector for ultrasound head 0.8 / 2.4MHz
18
Socket for electrode cable channel I
Note: The socket (15*) has no use for the Soleoline.
12
13
(15*)
14
16
17
18

Explanation of Symbols
VacoS
Front panel/sockets
Fig. 5
Ports
Group 1
19
Socket for Vaco electrode tube black, cathode
20
Socket for Vaco electrode tube red, anode
Group 2
21
Socket for Vaco electrode tube black, cathode
22
Socket for Vaco electrode tube red, anode
19
20
22
21

Explanation of Symbols
VacoS
Rear Panel/Switches and Connector Sockets
Fig. 7
Switches and
connector sockets
23
On/off switch
24
Connection for short mains connection cable
25
Connection for mains cable
26
Bracket for mains backup
27
Socket for electrode cable channel II
28
Socket for connection cable with SonoStim/Galva channel II
29
Socket for electrode cable channel I
30
Socket for connection cable with SonoStim/Galva channel I
31
Soleo SonoStim / Galva identification plate
32
Soleo VacoSidentification plate
23
24
25
26
27
28
29
30
31
32

Explanation of Symbols
Soleo SonoStim / Soleo Galva / VacoS
Side view
Fig. 8
Connections
33
Water separator connector valve
33

Explanation of Symbols
Soleo SonoStim / Soleo Galva
Ultrasound heads
Fig. 9
Ultrasound head, large Ultrasound head, small

Explanation of Symbols
In the instructions for use, thissymbolindicates “Danger”.
Caution
!
In the instructions for use, thissymbolrepresents "Caution" with regard to
damage ofthe 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 SonoStim/Soleo Galva
Front panel
Display/ Navigation bars
Rear panel / Switches and connector sockets
VacoS
Front panel/sockets
Rear panel / Switches and connector sockets
Soleo SonoStim/Soleo Galva and VacoS
Side view
Ultrasound heads
Explanation of Symbols
Page
1Indications/Contraindications
1.1 Electrotherapy indications
1.2 Electrotherapy contraindications
1.3 Ultrasound therapy indications
1.4 Ultrasound therapy contraindications
1
3
4
5
2
Side Effects 6
3Application Information
3.1 General
3.2 Electrotherapy
3.3 Ultrasound
7
8
9
4 Warnings
4.1 General
4.2 Electrotherapy 10 11
5
Soleoline – in brief 12
6
Intended Use 13
7
7 Device Set up
7.1 Installation of Soleo SonoStim/Soleo Galva cables
7.2 Installation of the VacoScable
14
15

Contents
8
Basic Settings
8.1 General
8.2 Electrotherapy
8.3 Ultrasound Therapy
8.4 Maintenance
17
21
22
23
9
Soleo SonoStim - Instructions for operation
9.1 Electrotherapy
9.2 Ultrasound Therapy
9.3 Water Bath Treatment
9.4 Simultaneous Therapy
24
29
33
34
10
Soleo Galva - Instructions for operation
10.1 Electrotherapy 37
11
Soleo SonoStim/Soleo Galva - Instructions for operation
11.1 Electrotherapy with VacoS
11.2 Water separator VacoS
11.3 SD card
11.4 Menu indications
11.5 Storing Programmes
11.6 Retrievingprogrammes/Editing the list
11.7 Programme sequence
38
41
42
43
45
47
49
12
Paralysis Diagnosis and Therapy
12.1 Overview
12.2 Medium frequency test by Lange
12.3 Neofaradic test
12.4 Chronaxie/accomodation quotient
12.5 Fisch Gold Test
51
52
53
54
57
13
Technical Information
13.1 Soleo SonoStim/Soleo Galva - General
13.2 Stimulation
13.3 Ultrasound
13.4 VacoS
59
60
62
63
14
Cleaning / Disinfection
64
15
Electrodes - Information on use of the various types of electrodes 66
16
CE mark / manufacturer 67

Contents
17
Scope of Delivery, Accessories
17.1 Soleo SonoStim
17.2 Soleo Galva
17.3 VacoS
68
69
70
18
Device Combinations 71
19
Safety and Maintenance 72
20
Function Test 73
21
Legal Notices 74
22
Error Message, Troubleshooting, Disposal 75
23
Manufacturer's EMC Declaration 79
Valid for devices Soleo SonoStim, Soleo Galva and VacoS.
These instructions for use are an integral part of the device.
It must be stored with the device and kept accessable at all times for anyone to
operate this device.
The instructions for use are valid from August 2016.

Indications / Contraindications
1.1 Electrotherapy indications
1
Page 1
Circulation promotion
treatment
•Functional circulatory disorders
•Angiopathy in diabetes mellitus
•Angioneuropathy (M. Raynaud)
•Acrocyanosis
•Arterial occlusive disease (stage I/IIa)
•Venous vascular disease
•Chronic venous insufficiency
•Sympathetic reflex dystrophy
•Sudeck syndrome (stage II)
•Disruption of trophism
•Lymphedema
•Fascia treatment (as pretreatment)
•Chronically tense muscles
•Disease of the peripheral joints (chronic)
•Radicular syndromes with spinal disorders (subacute and chronic)
•Ligament ruptures
•Tenosynovitis
•Bursitis
Analgesic therapy
•Sprains, contusions, muscle sprains,
•Tendons, joints and bones
•Large myalgia
•Polyarthralgia
•Joint diseases, inflammatory
•Chronic polyarthritis (rheumatoid arthritis),treatment ininflammatory poor
intervals
•Diffuse pain in periarthropathy, arthrosis,
•M. Bechterew
•Tendinitis, tenosynovitis
•Local and pseudoradicular spinal disorders
•Radical lesions
•Disc surgery
•Chronic inflammatory spinaldiseases
•Chronic pain conditions, pain disorder
•Pelvipathy (so-called adnexitis)
•Pelvipathy (so-called prostatitis)
•Neuralgia
•Neuritis
•Polyneuropathy
•Radicular syndrome
•Nerve compression syndrome
•Allodynia
•Causalgia

Indications / Contraindications
1.1 Electrotherapy indications
1
Page 2
Trophism promotion
treatment
•Venous ulcers
•Neurotrophic ulcers
•Decubitus ulcers
•Delayed wound healing
•Osteoporosis
•Delayed bone healing
•Ligament ruptures
Muscle toning therapy
•Muscle weakness
•Voluntary innervation weakness
•Missing muscle feeling
Muscle detoning therapy
•Overloading the muscles
•Painful muscular tension
•Myofascial pain syndromes
•Tendon and muscle rupture
•Contractures
Other indications
•Periarthropathies and insertion tendinopathies (acute, subacute)
•Periarthropathies and insertion tendinopathies (chronic)
•Disease in the peripheral joints (acute, subacute)
•Post-traumatic state images (hematoma, edema)
•Excessive sweating of handsand feet
(hyperhidrosis palmarum and plantarum)
•Spinal disorders acquired: post-traumatic, post inflammatory,degenerative
•Posture spinal disorders in childhood and adolescence
•Spinal fractures, spinal fusion
•Joint surgery, arthroscopy, arthrotomy
•Congenital malformations or incorrect settings of the musculoskeletal system to
be treated in childhood
•Fecal incontinence
•Urinary incontinence
•Disruption of gut motility
•Chronic constipation
•Secondary lymphedema and lymphoedema
•Pelvic pain
•Polyneuropathy
•Anterior horn of the spinal cord disease
•Peripheral paralysis, brachial plexus
•Non-local, generalised spinal disorders
•Spasticity
•Spastic paresis
•Flaccid paralysis

Indications / Contraindications
1.2 Contraindications for electrotherapy
1
Page 3
General
Contraindications
•Vague pain symptoms
•Acute inflammation (local,systemic)
•Suspected diseases of the cardiovascular system
•(Suspected) epilepsy
•Arterial occlusive disease fromstage IIb according to Fontaine
•Purulent processes
•Fever
•General infections
•Tumours of amalignant and benign nature
•Thrombophlebitis
•DVT at risk of embolism
•Pacemakers and other implanted electronic devices
•Transcardial current flow
•Metal implantsin the current field when using galvanic or unipolar currents with
pulse widths of more than 1 ms
•Psychosis
•Reduced skin sensitivity
•Application on orin the vicinity of open woundsor fractures
The following should
also be considered
when planning TENS
therapy
•Causally repairable pain
•Predominantly psychogenic pain (TENS therapy is ineffective)
•Central pain syndromes, for example thalamic pain syndrome
In addition the
following
contraindications
should be observed
Muscle treatment with swollengroup pulses (threshold currents) incase of:
•Unconsciousness, consciousness
•Reflex inhibition (e.g. fractures)
•Muscle inflammation
•Mimetic facial muscles
•If the electric stimulationtherapy triggers persistent pain
•Infants, toddlers
•When spasticity increases
•Pregnancy
Particular caution is required:
•With bleeding after acute trauma or fracture
•After surgicalprocedures when muscle contraction may disrupt the healing
process
Precautions for certain
current forms
Diadynamic current, trabert current
•A careful electrode technique is necessary to avoid possible skin damage
through a high galvanic share of diadynamic currents
•Cautious dosing in case of sensory disturbances
Electroacupuncture
•No needle acupuncture in bleeding disorders

Indications / Contraindications
1.3 Indications for ultrasound therapy
1
Page 4
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 of delayed callus formation)
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 the stomach and duodenum
•Pelvic pain
•Functional disorders of the pelvis

Indications / Contraindications
1.4 Contraindications for ultrasound therapy
1
Page 5
General
Contraindications
•Vague pain symptoms
•Diseases whereheat should not be used, for example, 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 higher than C3
•Ultrasound treatment of parenchymatous or heat-sensitive organs (testes, eyes,
gravid uterus, liver, kidneys etc.)
•Anaesthetised skin areas
•Temperature sensitivity disorders
•After treatment with ionising 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 when pregnant orpresumed
pregnant
Metal implants and endoprostheses
Dynamic ultrasound radiation in low dosage is nowadays no longer a matter for
concern.

Side Effects
2
Page 6
Side effects of
electrotherapy
If used correctly,no side effects are known.
Side effects of
ultrasound therapy
If used correctly,no side effects are known.

Application Information
3.1 General
3
Page 7
Prior to the application of the device to the patient, the user should become
acquainted with the operating instructions or theindividual treatment methods and
also with the indications / contraindications, warnings and directions for use.
Additional sources of information on ultrasound therapy should also be taken into
consideration.
This user manualshould always be kept with the device to enable the persons
charged with theoperation ofthe device to access it at any time.
Caution
!
To avoid the risk of electric shock, the device must be disconnectedfrom the mains
supply before performing any maintenance 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 VDE0100 Part 710). The
device must only be operatedwith the supplied power cord. 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 vicinity of devices that generate strong
electromagnetic fields (X-ray or diathermy devices, MRI scanners). Please keep a
safe distance of several metres.
Caution
!
The device is not suitable for use in areas with an explosive, combustible or
combustion-promoting atmosphere.
Caution
!
During use, the device must be placed in such a waythat 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 not be used.
Caution
!
Only accessories provided byZimmer MedizinSysteme GmbHare to be used and no
other devices must be connected to the VacoS.
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 systemmay 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.