Physiomed PHYSIOSON-Basic User manual

OPERATING INSTRUCTIONS
PHYSIOSON-Basic
MAINS OPERATED MODEL
BATTERY OPERATED MODEL
00929 GB

The technical data in this manual is as at the time of printing and subject to alteration.
Copyright © 2003-2010 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
Symbols
CAUTION!
Please refer to the operating instructions and consider the physiological effects!
Type BF component, not connected to protective ground wire!

Instrument Overview
Front Panel
1 2
3
Rear Face
4
5
Lateral View
6
Legend
1 Display 2 Data Selector 3 Transducer Connector
4 SIM Socket 5 Mains module / Mains
switch
6 Power Switch

Contents
1Introduction......................................................................................................................1
1.1 Instrument 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 Display <1> .................................................................................................................................3
2.1.1.1 Upper Status Bar<2> ............................................................................................................... 3
2.1.1.2 Lower Status Bar ..................................................................................................................... 4
2.1.1.3 Dose Indicator ......................................................................................................................... 4
2.1.1.4 Individual Programs ................................................................................................................. 4
2.1.1.5 Indications Menu..................................................................................................................... 4
2.1.1.6 Setup Menu ............................................................................................................................ 4
2.1.2 Data Selector <2> .......................................................................................................................4
2.1.3 Transducer Connector <3>..........................................................................................................5
2.1.3.1 Ultrasonic Transducers............................................................................................................. 5
2.1.3.2 Automatic Coupling Confirmation........................................................................................... 5
2.1.4 SIM Socket <4>...........................................................................................................................5
2.1.5 Mains Module <5>......................................................................................................................6
2.1.6 Power Switch <6> .......................................................................................................................6
2.2 Overview of Parameters..............................................................................................................7
3Notes on Operation ......................................................................................................... 9
3.1 Operation in mains or battery mode..........................................................................................9
3.1.1 Notes on handling the batteries...................................................................................................9
3.1.2 Economy operation .................................................................................................................. 10
3.2 Start-up ...................................................................................................................................... 11
3.3 Function Check .......................................................................................................................... 11
3.4 Instrument Errors ...................................................................................................................... 11
4Ultrasound Therapy .......................................................................................................12
4.1 General Information ................................................................................................................. 12
4.2 Therapy ...................................................................................................................................... 12
5Simultaneous Therapy ...................................................................................................14
6Indications Menu............................................................................................................ 16
7Individual Programs .......................................................................................................17
7.1 Save and Edit Program ............................................................................................................. 17
7.2 Call Program .............................................................................................................................. 18
8Basic Settings..................................................................................................................19
8.1 Setup Menu ............................................................................................................................... 20
9General Notes.................................................................................................................21
10 Service, Repairs, Maintenance ......................................................................................21
11 Cleaning and Disinfection .............................................................................................22
12 Connecting a Stimulation Current Unit ........................................................................22

13 Technical data.................................................................................................................23
14 Accessories......................................................................................................................24
14.1 Standard Accessories ............................................................................................................24
14.2 Additional Accessories ..........................................................................................................24
15 Manufacturer’s Recommendations............................................................................... 25
16 Test Certificate ......................................................................Error! Bookmark not defined.
17 Index ...............................................................................................................................26

Introduction
1Introduction
With your PHYSIOSON-Basic, you have acquired an extremely versatile 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
familiarise yourself with the use of the instrument.
1.1 Instrument Description
PHYSIOSON - Basic is a modern, easy-to-handle ultrasound therapy unit with LCD.
Both transducers (2.5 cm2/ 5 cm2) work with the frequency 1 MHz.
The device can be equipped with a rechargeable battery and then be used as a
mobile unit, e.g. in situations where no connection to the mains is available.
Therapy modes may be accessed
directly or, by a proposed treatment, via the
indications menu. Moreover, the unit enables you to store 20 individually adjustable
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.
PHYSIOSON - Basic is controlled in its functions by a microprocessor. Essential
components are permanently controlled by the processor and thus faulty operation
is prevented. After switching on, all instrument functions are checked during an
automatic self-test routine. The instrument complies with all current safety
standards.
The instrument meets the requirements of the EC directive concerning medical
devices (93/42/EEC) and is therefore CE-labelled.
1.2 Application
PHYSIOSON - Basic 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
PHYSIOSON-Basic 1

Introduction
Simultaneous Therapy
•Simultaneous application of stimulation current and ultrasound (together with
an external stimulation current therapy instrument)
Caution
The instrument may only be operated by qualified personnel who have
undergone special training!
1.3 Contraindications
Contraindications to ultrasound therapy or simultaneous treatment:
•Fever-prone disorders and acute inflammatory processes
•Pregnancy
•Tuberculosis, gastric ulcers
•Vascular disorders of the extremities (thrombophlebitis, thrombosis, varicosis)
•Tumours
•Circulatory insufficiency, coronary diseases, cardiac dysrhythmias
•Acute articular rheumatism
•Diabetes mellitus
•Septic inflammations
•Conditions following radiothorium treatments, X-ray therapy
•Laminectomy
•Skin lesions (infections, inflammatory processes, naevi)
•Tumescences at all stages (pre-/postoperative)
•Blood coagulation diseases.
Do not apply ultrasound or simultaneous therapy close to the brain, spinal cord and
eyes!
2 PHYSIOSON-Basic

Controls and Indicators
2Controls and Indicators
As its LCD is divided into different function fields, PHYSIOSON - Basic allows for clear
and easy operation.
The metal housing and the front panel protect the electronic components and
simplify cleaning.
Safety-related components are continuously monitored by the microprocessor,
erroneously initiated operating steps are suppressed, a self-test routine is performed
after switching on and possible malfunctions are displayed. For safety reasons, the
transducers are automatically disconnected in case of malfunction.
2.1 Function of Controls and Indicators
In the following section, we will introduce the individual controls of PHYSIOSON -
Basic. The numbers in angle brackets refer to the Instrument Overview at the
beginning of this manual.
2.1.1 Display <1>
In the display <1>, all therapy parameters of the
unit are shown. The selection is carried out with the
data selector <2>.
More information on the individual options can be
found in section
Overview of Parameters on page 7.
2.1.1.1 Upper Status Bar
The upper status bar shows the corresponding parameters selected:
•Ultrasound therapy / simultaneous therapy
•Mode (duty cycle / continuous mode)
•Transducer activated (5 cm2 / 2.5 cm2)
•Optic coupling confirmation (with dose turned high)
•Acoustic coupling confirmation (optional, with dose turned high)
In addition, prompts and instructions are displayed, e.g. Plug in Head
More information on the individual symbols can be found in section Overview of
Parameters
on page 7.
PHYSIOSON-Basic 3

Controls and Indicators
2.1.1.2 Lower Status Bar
When selecting an indication (cf. page 16), the name of the indication is issued in
the lower status bar. When selecting an individual program (cf. page 17), the
currently selected parameters are displayed.
2.1.1.3 Dose Indicator
The dose indicator indicates the therapy dose selected.
The dose can be displayed in W/cm2or W. The mode for
display may be changed in the basic settings or in the
setup menu.
Use the data selector <2> to set the dose. To do this click the dose symbol
(which will begin flashing). Turn the data selector <2> to adjust the dose.
Note
For safety reasons, the following optional (setup menu) setting can be
selected: Increasing the ultrasound dose after coupling (marker is
displayed) is only possible after the dose has been turned down with
the data selector <2>.
2.1.1.4 Individual Programs
In the individual programs, individual treatment programs and
frequent standard applications can be stored on a short-term or
long-term basis. More information can be found on page 17.
2.1.1.5 Indications Menu
The indications menu enables you to access therapy via an
alphabetically sorted indications menu, with automatic call of a
treatment program featuring a suggested dose. More
information can be found on page 16.
2.1.1.6 Setup Menu
In the setup menu, the basic settings may be selected. More
information can be found on page 19.
2.1.2 Data Selector <2>
Use the data selector <2> to select the therapy
parameters and to operate the instrument by means
of the cursor. After switching on the instrument, the
cursor is located at the therapy timer of the display
<1>.
To select a parameter, move the cursor to the
respective field by turning the selector. After pressing
the selector, the cursor will start flashing. You will
then be able to select the parameters by turning the
selector and confirm the selected value by pressing
the selector again (cursor stops flashing).
4 PHYSIOSON-Basic

Controls and Indicators
The modified values are displayed in the upper status bar or at the respective
position of the display <1>.
With the dose turned high, safety-related parameters cannot be varied. At the
attempt to alter a parameter, the turn-down signal ( ) appears in the
lower status bar and an acoustic signal is issued.
As safety-related components are considered:
, and (when turning up).
2.1.3 Transducer Connector <3>
Through the transducer connector <3> the
ultrasonic transducer is connected to the
instrument. The transducers are automatically
calibrated after connecting the transducer(s)
and/or switching on the instrument.
2.1.3.1 Ultrasonic Transducers
The Ultrasonic Transducers (2.5 cm2and 5
cm2) are both calibrated automatically after they
are plugged in or the device is switched on.
The transducers are watertight and can be used
for underwater treatment.
2.1.3.2 Automatic Coupling Confirmation
There is an optical coupling confirmation at the transducers for ensuring efficient
therapy. In case of poor coupling, the light on the transducer will become active.
You may choose to count only the efficient therapy time or to run the therapy timer
independent of proper coupling in the setup menu.
Caution
The transducers contain fragile ceramic piezo-resonators. Avoid shocks
to the surface and take special care that they are not dropped.
Handling malpractices can change the characteristics of the resonator!
2.1.4 SIM Socket <4>
The SIM socket <4> serves to connect to a PHYSIOMED
stimulation current therapy unit (see also
Simultaneous
Therapy
on page 14).
PHYSIOSON-Basic 5

Controls and Indicators
2.1.5 Mains Module <5>
The mains module <5> with the mains switch is located on the
rear side of the unit. Use this switch to connect PHYSIOSON
- Basic
to the mains or disconnect it.
For mains supply do only use the mains cable provided by the
manufacturer.
2.1.6 Power Switch <6>
The power switch <6> seen from the front is located on the left
side of the unit. Use this switch to turn the unit on and off.
The device will conduct a short calibration of the transducer as well
as an automatic self test after being switched on (cf.
Notes on
Operation
on page 8).
Note
To work with the unit and to charge the battery the mains switch
<5> as well as the power switch <6> have to be switched on.
6 PHYSIOSON-Basic

Controls and Indicators
2.2 Overview of Parameters
Use the display <1> to set all available therapy parameters. The current settings are
displayed in the upper status bar.
The symbols on the display <1> have the following significance. The corresponding
symbols which are also displayed when active are shown in the right column:
upper status bar
Selected therapy time
Selected intensity; the marker (arrow) shows the fixed dose which
cannot be exceeded during treatment (automatic memory)
Therapy mode (ultrasound output)
cont. continuous ultrasound output
1:10 pulsed ultrasound emission with the specified
duty cycle (possible values 2:5, 1:3, 1:5, 1:10)
Type of ultrasound treatment
ultrasound only
simultaneous treatment
(ultrasound + stimulation current)
Individual programs (user-defined)
selected dose
indications menu setup menu
timer elapsed therapy
time
therapy
parameters
simultaneous
therapy
individual
programs
PHYSIOSON-Basic 7

Controls and Indicators
Indications menu
Setup menu, selection of basic settings
In the upper status bar, 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 17), the currently selected parameters are
displayed.
Example: Symbols in the upper status bar:
pulsed US emission,
ratio 1:10 US frequency 1 MHz
8 PHYSIOSON-Basic
loading battery
Example: Symbols on the display:
Dose selection (0-3 W/cm2)
Optical coupling control
No coupling (LED on transducer flashes)
Coupling
Acoustic coupling control active
(cf.
Setup Menu on page 20)

Notes on Operation
3Notes on Operation
3.1 Operation in mains or battery mode
PHYSIOSON - Basic is available in two designs:
•for mains operation only
•for mains or battery operation
For battery operation, the battery must have been charged before. Proceed as
follows:
(1) Make sure that the unit is turned off. Insert the supplied mains connector
cable into the mains socket on the rear side of the device.
(2) Connect the mains cable to the mains (110 V)
(3) Switch on mains switch <5> and power switch <6>.
The batteries are charged. When the batteries are completely discharged, the
charging procedure will take approx. 12 hours. The charging status of the batteries
is displayed in the upper status bar.
Charging
Battery operation
Battery charged
Note
In order to ensure a long battery life, the batteries must be charged
completely when first charged.
The first charging procedure should not be interrupted!
3.1.1 Notes on handling the batteries
If battery capacity is very low during operation, the 2-step warning system is
activated.
Step 1: In the upper status bar, the alternating messages * Charge battery !!! * and
the usual display are shown.
Step 2: The device shuts down to avoid complete discharging of the battery.
PHYSIOSON-Basic 9

Notes on Operation
If the battery capacity is very low when the device is switched on, a message will be
shown in the display. In this case, charge the battery as described on page 9. You
can continue using the unit in mains operation while the battery is charged.
Note
If the unit is not used for a longer period of time, please charge the
battery once a month. This will help to avoid exhaustive discharge.
3.1.2 Economy operation
To save power, the unit automatically switches over to the economy mode when the
dose is "0". One of the following symbols is shown in the display:
Mains operation
Mains switch activated
Charging battery
Mains switch activated
Battery charged
Battery operation
No connection to the mains
Turning the data selector <2> will immediately take you back to the main menu.
10 PHYSIOSON-Basic

Notes on Operation
3.2 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.
Make sure that the instrument is switched off.
(1) Plug the transducers into the transducer connector <3>.
(2) Switch on the unit with the mains switch <5> and the power switch <6>.
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) Switch off the unit using the power switch <6>, wait until the light at the
transducer is off and then switch the unit on again.
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.
3.4 Instrument Errors
If a functional error is detected during the automatic function check or during
operation, a corresponding note will be displayed on the LCD. A numeric error code
will be shown, e. g. <ERROR 10>. These error codes simplify localising and
eliminating errors.
Operation of the unit will be interrupted and the transducer will be switched off.
Switch off the unit using the mains switch <5>, wait until the light at the
transducer is off and then switch the unit 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
harmless spikes in the power line.
PHYSIOSON-Basic 11

Ultrasound Therapy
4Ultrasound Therapy
4.1 General Information
PHYSIOSON - Basic offers you three possibilities to start ultrasound therapy:
•direct start
•starting via the indications menu with its treatment proposals for a multitude
of applications (page 16).
•starting via individual programs (created by yourself, page 17).
See the supplied ultrasound therapy booklet for additional information.
4.2 Therapy
Treatment Procedure
Make sure that the instrument is ready for operation.
(1) Choose the appropriate transducer and plug it into the transducer
connector <3>.
(2) Apply ultrasound gel to the area of treatment.
(3) Set the therapy time.
(4) Select the therapy mode using the function MODE.
(5) Activate the acoustic coupling confirmation via SET, if required..
(6) Slowly turn up the intensity with the data selector <2>.
Note
For safety reasons, the following optional (setup menu) setting can be
selected: Increasing the ultrasound dose after coupling (marker is
displayed) is only possible after the dose has been turned down with
the data selector <2>.
When the transducer is coupled, the green LED at the transducer goes off and the
timer starts to run. The therapy timer switches off as soon as the treatment is
finished.
12 PHYSIOSON-Basic

Ultrasound Therapy
Automatic Coupling Confirmation
There is an optical coupling confirmation at the transducers for ensuring efficient
therapy. When the ultrasound waves penetrate the tissue of the patient in an
optimal way, the LED at the transducer will go off and two additional waves are
displayed at the transducer symbol.
You may choose to count only the efficient therapy time or to run the therapy timer
independent of proper coupling in the setup menu.
We recommend checking the function of the coupling confirmation by shortly
removing the transducer from the tissue prior to treatment.
Caution
Make sure you constantly keep moving the transducer on the area of
treatment (dynamic treatment)!
Avoid using the transducer at one spot for a longer time (static
treatment); this form of treatment might lead to damage to the tissue!
Regularly check transducers and resonators for overheating!
PHYSIOSON-Basic 13

Simultaneous Therapy
5Simultaneous Therapy
Simultaneous therapy means the simultaneous treatment with ultrasound and
stimulation current. That means that the effects of both forms of therapy can be
utilized. The ultrasonic transducer of the ultrasound unit is one pole of the
stimulation current circuit, a plate electrode of the stimulation current unit the other
one.
The PHYSIOSON
- Basic can be combined with a stimulation current therapy device
for simultaneous therapy. The PHYSIOSON
- Basic and the stimulation current device
may only be connected with a specially coded connector.
Caution
The safety precautions for the individual therapies also apply for the
simultaneous therapy!
Note
During simultaneous therapy, the PHYSIOSON
- Basic controls the timers
of both therapy devices.
To ensure a stable contact for both stimulation and ultrasound therapy you must
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 are 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.
Caution
Make sure you constantly keep moving the transducer on the area of
treatment (dynamic treatment)! Avoid using the transducer at one
spot for a longer time (static treatment); this form of treatment might
lead to damage to the tissue!
Regularly check transducers and resonators for overheating!
Note
If the transducer is lifted during treatment, the stimulation current will
automatically be reduced to 0; it ensures that both therapy modes -
ultrasound and stimulation current - are always applied
simultaneously. As soon as the transducer is put on again the
stimulation current will also rise again automatically.
14 PHYSIOSON-Basic