Physiomed PHYSIOSON-Expert User manual

OPERATING INSTRUCTIONS
PHYSIOSON-Expert
00851 GB

The technical data in this manual is as at the time of printing and subject to alteration.
Copyright © 2000 - 2010 by PHYSIOMED ELEKTROMEDIZIN AG
All rights, including rights of translation, reproduction by printing, copying or similar methods,
even of parts are reserved.
Offenders will be liable for damages.
Last updated August 30, 2010.

Instrument Overview
Front Panel 7
Rear Plate
3 5 64 10 11
12
9
8
2
1
Legend
1 Mains Module 5 Data Selector 9 Indications Menu
2 Upper Status Bar 6 Dose Control 10 Setup Menu
3 Display 7 Dose Indicator 11 Transducer Connectors
4 Lower Status Bar 8 Individual Programs 12 SIM Socket
Symbols
CAUTION!
Please refer to the operating instructions and consider the physiological effects!
Type BF component, not connected to protective ground wire.

Contents
1Introduction......................................................................................................................1
1.1 Description....................................................................................................................................1
1.2 Application ...................................................................................................................................1
1.3 Contraindications.........................................................................................................................2
2Controls and Indicators.................................................................................................... 3
2.1 Function of Controls and Indicators ...........................................................................................3
2.1.1 Mains Module <1>......................................................................................................................3
2.1.2 Upper Status Bar <2>..................................................................................................................4
2.1.3 Display <3> .................................................................................................................................4
2.1.4 Lower Status Bar <4>..................................................................................................................4
2.1.5 Data Selector <5> .......................................................................................................................4
2.1.6 Dose Control <6>........................................................................................................................5
2.1.7 Dose Indicator <7>......................................................................................................................5
2.1.8 Individual Programs <8>..............................................................................................................5
2.1.9 Indications Menu <9> .................................................................................................................6
2.1.10 Setup Menu <10> .......................................................................................................................6
2.1.11 Transducer Connectors <11> ......................................................................................................6
2.1.12 SIM Socket <12>.........................................................................................................................6
2.2 Overview of Parameters..............................................................................................................7
3Notes on Operation ......................................................................................................... 9
3.1 Connection and Start-up .............................................................................................................9
3.2 Device start-up .............................................................................................................................9
3.3 Function check..............................................................................................................................9
3.4 Instrument Errors ...................................................................................................................... 10
4Ultrasound Therapy .......................................................................................................11
4.1 General Information ................................................................................................................. 11
4.2 Therapy ...................................................................................................................................... 11
4.3 TPS.............................................................................................................................................. 12
5Simultaneous Therapy ...................................................................................................14
6Indications Menu............................................................................................................16
7Individual Programs .......................................................................................................18
7.1 Save and Edit Program ............................................................................................................. 18
7.2 Start Program ............................................................................................................................ 18
8Basic Settings..................................................................................................................20
8.1 Setup Menu ............................................................................................................................... 21
9General Notes.................................................................................................................22
10 Service, Repairs, Maintenance ......................................................................................22
11 Cleaning and Disinfection .............................................................................................23
12 Connecting a Stimulation Current Unit ........................................................................23
13 Technical Data ................................................................................................................24

14 Accessories......................................................................................................................25
14.1 Standard Accessories ............................................................................................................25
14.2 Other Accessories .................................................................................................................. 25
15 Manufacturer’s Recommendations............................................................................... 27
16 Index ...............................................................................................................................28

Introduction
1Introduction
With your PHYSIOSON-Expert,you have acquired a high-tech ultrasound therapy
unit.
The instrument will only show its true potential, however, if you are well informed
about its functions. For this reason, carefully read the
Operating Instructions and
familiarize yourself with the use of the instrument.
1.1 Description
PHYSIOSON-Expert is a modern, easy-to-handle ultrasound therapy unit with LCD.
Both transducers (2.5 cm2/ 5 cm2) work with the frequencies 1 and 3 MHz.
Therapy with the PHYSIOSON-Expert may be accessed
directly or, by a proposed
treatment, through the indications menu. Moreover the unit enables you to memo-
rize 20 individually adjustable and quickly called treatment programs.
The ultrasound may be applied in continuous as well as in pulsed mode. The unit
can be combined with stimulation current units (simultaneous therapy). The
transducers are watertight and may be used for underwater treatment.
All functions of the PHYSIOSON-Expert are controlled by a microprocessor, which
also continuously monitors all important components and suppresses erroneously
initiated operating steps. After switch-on, all instrument functions are checked dur-
ing an automatic self-test routine.
The instrument meets the requirements of the EC Directive concerning medical de-
vices (93/42/EEC) and is therefore CE-labelled.
1.2 Application
PHYSIOSON-Expert was designed for the following applications:
•Punctual heat therapy in the reach of joints, nerves, tendons and muscles
•Pain treatment in case of arthrosis and non-articular rheumatism
•Trophism improvement in case of posttraumatic conditions and Ulcus cruris
•Supporting passive and active exercises
Simultaneous Therapy
•The instrument can be used for simultaneous application of stimulation current
and ultrasound (together with an external stimulation current therapy instru-
ment).
Warning
The instrument should only be used by qualified personnel who have
undergone special training!
PHYSIOSON-Expert 1

Introduction
1.3 Contraindications
Contraindications to ultrasound therapy and simultaneous therapy:
•Fever-prone disorders and acute inflammatory processes
•Pregnancy
•Tuberculosis, gastric ulcer
•Vascular disorders of the extremities (thrombophlebitis, thrombosis, varicosis)
•Tumors
•Circulatory insufficiency, coronary diseases, bradyarrhythmia
•Acute articular rheumatism
•Diabetes mellitus
•Septic inflammations
•Conditions following radiothorium treatments, X-ray therapy
•Laminectomy
•Skin lesions (infections, inflammatory processes, naevi)
•Tumescence
•Blood coagulation diseases
Do not apply ultrasound close to the brain, spinal cord and eyes.
PHYSIOSON-Expert
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Controls and Indicators
2Controls and Indicators
Due to the subdivision of its comfort LCD, PHYSIOSON-Expert allows for easy opera-
tion despite of its vast range of functions.
The plastic housing and the front panel protect the electronic components and sim-
plify cleaning.
Safety-related components are continuously monitored by the microprocessor, erro-
neously initiated operating steps are suppressed, a self-test routine is performed af-
ter switch-on and, in case of a malfunction, the transducers are automatically cut
off.
2.1 Function of Controls and Indicators
In the following section we will introduce the individual controls and indicators of
PHYSIOSON-Expert. The numbers in angle brackets refer to the Instrument Overview
at the beginning of this manual.
2.1.1 Mains Module <1>
The mains module <1> with mains supply, fuses and mains switch
is situated at the rear side of the apparatus.
For mains supply do only use the mains cable provided by the
manufacturer.
PHYSIOSON-Expert is switched on and off by using the integrated
mains switch. After switching on, a self-test and the calibration of
the transducers are automatically carried out by the instrument (cf.
Notes on Operation on page 8).
Setting the line voltage
After replacing the fuses you can run the apparatus with 230 V as well as 115 V
simply by using the rotatable fuse carrier at the mains module <1>. Fuses are situ-
ated under the cover of the mains module <1> in a fuse carrier. (Refer to section
Technical Data on page 24 for safety data.)
Replace 500 mA fuses with 1 A fuses, turn the fuse carrier by 180° and insert it
again, so that the “red window” of the mains module <1> reads “115 V”, after
the cover has been closed again.
Warning
Set the line voltage at the mains module to match the incoming line
voltage.
PHYSIOSON-Expert 3

Controls and Indicators
2.1.2 Upper Status Bar <2>
The upper status bar <2> shows the corresponding parameters selected:
•Ultrasound therapy / simultaneous therapy
•Mode (duty cycle / continuous mode)
•Frequency (1 MHz / 3 MHz)
•Transducer activated (5 cm2 / 2.5 cm2)
•Optic coupling confirmation (with dose turned high)
•Acoustic coupling confirmation (optional, with dose turned high)
More information on the individual symbols can be found in section
Overview of Pa-
rameters
on page 7.
2.1.3 Display <3>
In the display <3>, you can select all
of the instrument’s parameters except
for the dose. Selection is carried out
using the data selector <5>.
An overview of the individual options
can be found in section
Overview of
Parameters
on page 7.
2.1.4 Lower Status Bar <4>
In the lower status bar <4>, messages and prompts are issued, e.g.:
Plug in head. When selecting an indication (cf. page 16), the name of the indication
is issued. When selecting an individual program (cf. page 18), the currently selected
parameters are displayed.
2.1.5 Data Selector <5>
Use the data selector <5> to select the therapy pa-
rameters and to operate the instrument using the
cursor. After switching on the instrument, the cursor
is located at the therapy timer of the display <3>.
To select a parameter move the cursor to the relevant
field by turning the selector. After pressing the selec-
tor, the cursor will begin flashing. You will then be
able to select the parameters by turning the selector
and confirm the selected value by pressing the selec-
tor again (cursor stops flashing).
The modified values are displayed in the upper status bar <2> or at the relevant
position of the display <3>.
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Controls and Indicators
2.1.6 Dose Control <6>
The dose control <6> serves for setting the therapy dose in
steps of 0,1 W/cm2. When turning up the dose, the therapy
timer is started in the display <3>.
Whenever you have to set the dose control <6> to “0”, the
following turn-down signal is displayed on the lower status
bar <4>:
For safety reasons, the dose control <6> is linked with the data selector <5>.
With the dose turned high, safety-related parameters cannot be varied. At the at-
tempt to alter a parameter, the turn-down signal ( ) appears in the lower
status bar <4> and an acoustic signal is issued.
As safety-related components are considered:
, , , and (when turning high).
The indications menu <9> and the setup menu <10>, too, can only be accessed
after turning the dose down to 0.
The instrument has a dose memory, i.e. the dose value selected is set upon the first
coupling and cannot be increased any more afterwards. The set value is indicated by
a marker showing the corresponding dose value.
Note
In order to prevent an overdose, PHYSIOSON-Expert automatically
switches to pulsed mode 2:5 as soon as the set dose limit is exceeded
in continuous mode. This limit is set to 2 W/cm2by default but may be
adjusted in the basic settings (cf.
Basic Settings on page 20).
2.1.7 Dose Indicator <7>
The dose indicator <7> indicates the therapy dose se-
lected. The dose can be displayed in W/cm2or W (op-
tional, setup menu <7> or basic settings).
For the procedure and features of selecting the parameters see dose control <6>.
Note
For reasons of safety, the following option may be selected in the
setup menu: Increasing the ultrasound dose after the ultrasound has
coupled (marker appears in the upper status bar <2>) is only possible
after prior turning down the dose with dose control <6>.
2.1.8 Individual Programs <8>
In the individual programs <8>, individual treatment programs
and frequent standard applications can be memorized on a
short-term or long-term basis. More information can be found
on page 18.
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Controls and Indicators
2.1.9 Indications Menu <9>
The indications menu <9> enables you to access therapy via an
alphabetically sorted indications menu, with automatic call of a
treatment program featuring a suggested dose. More informa-
tion can be found on page 16.
2.1.10 Setup Menu <10>
In the setup menu <10>, the basic settings may be selected.
More information can be found on page 20.
2.1.11 Transducer Connectors <11>
Through the transducer connectors <11> the
ultrasonic transducers are connected to the
instrument. The microprocessor recognizes
which transducer has been connected to which
of the two connectors. The transducers are
automatically calibrated after connecting the
transducer(s) and/or switching on the instru-
ment.
Ultrasonic Transducers
The ultrasonic transducers (2.5 cm2 and 5
cm2) work with the frequencies 1 MHz and 3
MHz. The transducers are automatically cali-
brated after connecting and/ or switching on
the instrument.
The transducers offer the highest possible safety
for ultrasound output. They are watertight and
can be used for underwater treatment.
Automatic Coupling Confirmation
There is an optical coupling confirmation at the transducers which goes out as soon
as there is efficient coupling. A further optical coupling confirmation is located in
the upper status bar <2>.It enables you to counter-check with the optical cou-
pling confirmation at the transducer. Just as the acoustic coupling confirmation, it
may be activated in the basic settings.
Warning
The transducers contain fragile ceramic piezo-resonators. Avoid shocks
to the surface and take special care that they are not dropped. Han-
dling malpractices can change the characteristics of the resonator.
2.1.12 SIM Socket <12>
The SIM socket <12> serves for connecting the unit with a
stimulation current unit PHYSIOMED-Expert for simultaneous
therapy (cf.
Simultaneous Therapy on page 11).
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Controls and Indicators
2.2 Overview of Parameters
On the display <3> you can set values for all therapy parameters. The current set-
tings are displayed on the upper status bar <2>.
The symbols on the display <3> have the following significance. The corresponding
symbols which are displayed on the upper status bar <2> when active, are shown
in the right column:
upper status bar <2>
Type of ultrasound treatment
ultrasound only
simultaneous treatment
(ultrasound + stimulation current)
Acoustic coupling confirmation
ACTIVE
(-) INACTIVE
Individual programs (user-defined)
Therapy mode (ultrasound output)
cont. continuous ultrasound output
1:10 pulsed ultrasound output with the indicated duty cy-
cle
(possible values 2:5, 1:3, 1:5, 1:10)
selected dose
indications menu <9> TPS menu
therapy time
ultrasound
parameters
lower
status bar <4>
setup menu <10>
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Controls and Indicators
Treatment frequency of ultrasound
(1 MHz or 3 MHz)
Size of the transducer / coupling
large transducer (5 cm2) active
coupling sufficient (with dose turned high)
small transducer (2,5 cm2) active
coupling sufficient (with dose turned high)
Selected intensity; the marker (arrow) shows the fixed dose
which cannot be exceeded during treatment (automatic
memory)
Selected therapy time
Example: Symbols on the upper status bar:
pulsed ultrasound output,
duty cycle 1:10 large transducer active
ultrasound
ultrasonic frequency
1 MHz
ultrasound treatment (only) acoustic coupling
confirmation active
PHYSIOSON-Expert
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Notes on Operation
3Notes on Operation
3.1 Connection and Start-up
Connecting the unit
(1) Check whether the operating voltage of the device (see red window in the
mains module)<1> ) and the line voltage correspond.
(2) Plug the supplied mains lead firmly into the rear panel of the device (mains
module <1>) and connect it to the socket. A safe connection is established via
a grounding socket outlet with ground wire.
3.2 Device start-up
Note
Prior to switching on the device, please make sure that the activated
ultrasonic transducer is outside the water in a clean condition.
(3) Make sure that the instrument is switched off.
(4) Turn the dose control <6> to 0.
(5) Plug the transducers into the transducer connector <11>.
(6) Switch on the device with the mains switch (mains module <1>).
The instrument will carry out an automatic function check during which all
functions and output values are checked and the transducer is calibrated.
An audible signal is issued.
The instrument is ready now. The parameters of the last treatment are preset.
3.3 Function check
(1) Turn the dose control <6> to 0.
(2) Switch the device off and on with the mains switch (mains module <1>).
The instrument will carry out an automatic function check during which all
functions and output values are checked and the transducer is calibrated.
An audible signal is issued.
The instrument is ready now. The parameters of the last treatment are preset.
PHYSIOSON-Expert 9

Notes on Operation
3.4 Instrument Errors
If a functional error is detected during the automatic self-test routine or during op-
eration, the instrument will be switched off, the transducers will be cut off and a
special error code will be displayed. These error codes (e.g. “ERROR 10“) simplify
the localization and elimination of errors.
The LCD shows:
Switch off the instrument and switch it on again. If the error code is still displayed
after several runs through the self-test routine, contact your service partner.
Note
Random instrument errors may conceivably occur as the result of harm-
less spikes in the power line.
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Ultrasound Therapy
4Ultrasound Therapy
4.1 General Information
The PHYSIOSON-Expert offers you three possibilities to start the ultrasound therapy:
•direct start,
•start via the indications menu with its proposals for treatment for a multitude
of applications (page 16),
•start via individual programs (created by yourself) (page 18).
See the supplied ultrasound therapy booklet for additional information.
4.2 Therapy
Therapy Procedure
Make sure that the instrument is ready.
(3) Choose the appropriate transducer and plug it into the transducer connector
<11>.
(4) Apply ultrasound gel to the area of treatment.
(5) Set the therapy time.
(6) Select the therapy mode using the function MODE .
Note
In order to prevent an overdose, PHYSIOSON-Expert automatically
switches to pulsed mode 2:5 as soon as the set dose limit is exceeded
in continuous mode.
This limit is set to 2W/cm2by default but may be adjusted in the basic
settings (cf.
Basic Settings on page 20).
(7) Select the ultrasonic frequency.
(8) Activate the acoustic coupling confirmation, if required.
(9) Turn up the dose with the dose control <6>.
PHYSIOSON-Expert 11

Ultrasound Therapy
Note
For reasons of safety, the following option may be selected in the
setup menu: Increasing the ultrasound dose after the ultrasound has
coupled (marker appears in the upper status bar <2>) is only possible
after prior turning down the dose with dose control <6>.
(10) Check the coupling confirmation by lifting the transducer shortly from the pa-
tients’ tissue.
The therapy timer switches off as soon as the treatment is finished.
Automatic Coupling Confirmation
The automatic coupling confirmation of the unit ensures efficient therapy at any
time. In the case of insufficient ultrasound transfer to the tissue, the LED at the
transducer as well as the coupling confirmation at the instrument (upper status
bar <2>) will light up. Apply more ultrasound gel until the coupling confirmation
goes out. With insufficient coupling (lamp lit) the therapy timer either automatically
stops running (see setting in the setup menu <10>), i.e. only efficient therapy time
is counted, or it continues running, i.e. the entire therapy time is counted independ-
ently of the coupling.
We recommend checking the function of the coupling confirmation by shortly re-
moving the transducer from the patient's tissue prior to treatment.
Warning
Move the ultrasonic transducer constantly on the patient's skin (dy-
namic treatment)! Make sure that the transducer never remains at the
same spot for a longer period (static treatment), otherwise tissue dam-
age of thermal and mechanical nature cannot be excluded!
Regularly check transducers and resonators for overheating!
4.3 TPS
The acronym TPS is based on the Spanish words Tiempo (time), Potencia (power) and Su-
perficie
(area). It represents a more precise dosage strategy in ultrasound therapy accord-
ing to the Spanish expert for electrotherapy Dr. J. M. Rodríguez Martín.
Besides the emitted dose in W/cm2, the area of treatment and the therapy time are taken
into account to apply a precisely specified amount of energy in J/cm2to the tissue.
Therapy Recommendations
Acute indications 15...25 J/cm2
Chronic indications 30...40 J/cm2
Chronic and fibrotic scars 40...50 J/cm2
PHYSIOSON-Expert
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Ultrasound Therapy
Treatment Procedure
(1) Make sure that the instrument is ready.
(2) Choose the appropriate transducer and plug it into the transducer connector
<11>.
(3) Apply ultrasound gel to the area of treatment.
(4) Click the TPS symbol. The TPS menu opens:
(5) Select the desired values of the variable parameters by rotating and pressing
the data selector <5>.
(6) Click Therapy to begin the treatment.
The selected and calculated parameters become active. The therapy time
elapses as soon as the transducer is being coupled to the tissue (refer to
Ultrasound Therapy on page 11).
The individual parameters one after the other have the following significance:
selected dose Refer to the
Treatment Recommenda-
tions
above
size of the area of treatment
selected output dose
size of the transducer is detected automatically; cannot be
selected
pulse ratio possible values: 1 (continuous), 1:10,
1:5, 1:3, 2:5 (refer to
Overview of Pa-
rameters
on page 7)
tolerance between nominal and
real output power
From experience, the tolerance value
between the nominal (desired) and the
real ultrasound emission might differ
between 10-20%, due to different rea-
sons. We recommend to keep a value of
10 to compensate this effect as good as
possible.
PHYSIOSON-Expert 13

Simultaneous Therapy
5Simultaneous Therapy
Simultaneous therapy means the treatment with ultrasound and stimulation current
at the same time. That means that the effects of both forms of therapy can be util-
ized. The ultrasonic transducer forms one pole of the stimulation current circuit, a
plate electrode the second one.
The PHYSIOSON-Expert can be combined with the stimulation current therapy de-
vice PHYSIOMED-Expert for a simultaneous therapy. The PHYSIOSON-Expert and the
stimulation current device may only be connected with a specially coded connector.
Warning
The safety precautions for the individual therapies also apply for the
simultaneous therapy!
Note
During simultaneous therapy, the PHYSIOSON-Expert controls the tim-
ers of both therapy devices.
In order to guarantee optimal contact for the stimulation current as well as the ul-
trasonic treatment, it is essential to use an electrically conductive ultrasound gel. The
standard polarity of the ultrasonic transducer is negative (cathode). The positive pole
(standard polarity positive: anode) is formed by the so-called neutral electrode. Plate
or vacuum electrodes can be used as neutral electrodes. Minimum size for the plate
electrode is EF50, for vacuum electrodes size 2. Additional peculiarities are described
in the list of accessories of your stimulation current device.
Warning
Move the ultrasonic transducer constantly on the patient's skin (dy-
namic treatment)! Make sure that the transducer never remains at the
same spot for a longer period (static treatment), otherwise tissue dam-
age of thermal and mechanical nature cannot be excluded!
Regularly check transducers and resonators for overheating!
Note
If the ultrasonic transducer is removed from the patient's skin during
treatment, the stimulation current is automatically reduced to 0 to
make sure the two treatments ultrasound and stimulation current are
always applied simultaneously. As soon as the ultrasonic transducer
touches the skin again, the stimulation current is built up again.
PHYSIOSON-Expert
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