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

Rear Face

Lateral View

Legend
1 Display 2 Data Selector 3 Transducer Connector
4 SIM Socket 5 Mains module / Mains 6 Power Switch
switch
Contents
1 Introduction...................................................................................................................... 1
1.1 Instrument Description ................................................................................................................1
1.2 Application ...................................................................................................................................1
1.3 Contraindications .........................................................................................................................2

2 Controls 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

3 Notes 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

4 Ultrasound Therapy ....................................................................................................... 12

4.1 General Information ................................................................................................................. 12
4.2 Therapy ...................................................................................................................................... 12

5 Simultaneous Therapy ................................................................................................... 14

6 Indications Menu............................................................................................................ 16

7 Individual Programs ....................................................................................................... 17

7.1 Save and Edit Program ............................................................................................................. 17
7.2 Call Program .............................................................................................................................. 18

8 Basic Settings.................................................................................................................. 19
8.1 Setup Menu ............................................................................................................................... 20

9 General 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

1 Introduction
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

2 Controls 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/cm2 or 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 cm2 and 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.

upper status bar

timer
elapsed therapy
time

selected dose
therapy
parameters

simultaneous
therapy
individual
programs

indications menu setup menu

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:
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)

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,
loading battery ratio 1:10 US frequency 1 MHz

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)

8 PHYSIOSON-Basic
 Notes on Operation

3 Notes 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

4 Ultrasound 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

5 Simultaneous 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
 Simultaneous Therapy

Proceed as follows to perform simultaneous therapy:

(1) Plug one connector of the connecting cable into the SIM socket <4> on the rear
side of the PHYSIOSON-Basic and the other one into the SIM socket of the
stimulation current device. Please ensure that the plugs are tightly fixed in the
socket.
(2) Check whether both devices are ready for operation.
(3) Attach the neutral electrode to the area to be treated.
(4) Apply ultrasound gel to the area of treatment.
(5) Set the therapy parameters on the display <1>.
(6) Rotate the data selector <2> until you reach the SIM symbol. Now press the data selector
<2>, rotate it one position further and press it once again to confirm. A small rectangle is
shown in the upper left corner of the SIM symbol to indicate that simultaneous therapy is
now activated.
(7) Select the current mode on the stimulation current device.
(8) Slowly turn up the intensity with the data selector <2>.
(9) Apply the activated transducer in the area of treatment and set the desired intensity
at the stimulation current device (slightly perceivable to strongly perceivable).
(10) Perform the treatment.
Make sure that there is enough space between the plate electrode and the
transducer. If there is too little room, an error might be issued.
At the end of treatment, the therapy timer of the PHYSIOSON-Basic switches off the
ultrasonic transducer as well as the stimulation current emission automatically.

PHYSIOSON-Basic 15
Indications Menu

6 Indications Menu
Apart from direct access to the individual ultrasound parameters, the indications
menu offers you another possibility to start treatment. With the indications menu,
you may utilise proven methods of treatment within ultrasound therapy.
Proceed as follows to start a treatment via the indications menu:
Choose the appropriate transducer and plug it into the transducer connector <3>.
Select the function IND. from the display <1>.
(1) Select the desired indication from the indications menu, e.g. Abscess.

A description of the recommended treatment is shown first.

(2) Now choose THERAPY.

The proposed parameters for the selected indication are displayed on the display.
(3) Apply ultrasound gel to the area of treatment.
(4) Activate the acoustic coupling confirmation, if required.
(5) Slowly turn up the intensity 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.

16 PHYSIOSON-Basic
 Individual Programs

7 Individual Programs
You do not have to set frequently applied forms of therapy every time you want to
use them – you can simply save them as individual programs. Such a program is e.g.
a certain therapy mode with all parameters including treatment time. You may save
individual programs and restart them as well as delete and overwrite them. You may
set 20 individual programs altogether.

7.1 Save and Edit Program

Proceed as follows to save an individual program or overwrite an existing one:

(1) Set the desired parameters.
(2) Set the dose while the transducer is in contact with the tissue to the desired
value using the data selector <2> and watch coupling of the transducer
(green LED at transducer goes off), until the dose indicator jumps to the set
value .
(3) Choose the function Individual programs .
(4) Select one of the programs F1 to F20 where you want to save your
parameters and press the data selector.
(5) Select the function Save program . The set parameters are displayed
in the menu.
(6) Press the data selector <2> in order to save the program at the desired
position.
The selected settings are saved in the respective program and can now be accessed.

PHYSIOSON-Basic 17
Individual Programs

7.2 Call Program

To call a saved program proceed as follows:

(1) Choose the appropriate transducer and plug it into the transducer
connector <3>.
(2) Open the programs menu via the button individual programs .
(3) Select one of the programs F1 to F20. The saved parameters are displayed in
the menu. The saved parameters of the respective programs are shown on
the upper status bar.
(4) Press the data selector <2> to select the desired program.
(5) Select the function Start program and press the data selector again.
The selected program is called. The respective parameters are displayed on the
display <1>.
(6) Apply ultrasound gel to the area of treatment.
(7) Slowly turn up the intensity with the dose control.
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.

18 PHYSIOSON-Basic
 Basic Settings

8 Basic Settings
In the basic settings menu, you can set different parameters that are rarely altered.
You can access the basic settings by keeping the data selector <2> depressed
when switching on the device with the power switch <6>.
The basic settings also contain some parameters of the setup menu.

You can select the following values in the basic settings:

Contrast of the LCD

Unit of the ultrasonic dose displayed on the

dose indicator: W or W/cm2

Dose threshold, i.e. where instrument switches from continuous to

pulsed mode

Link coupling confirmation with timer

YES Timer runs only with sufficient coupling
NO Timer runs independently of coupling

Dose limitation after ultrasound coupling:

YES Lock on increasing dose after coupling on
NO Lock on increasing dose after coupling off

Software version

Exit basic settings

PHYSIOSON-Basic 19
Basic Settings

To modify a parameter, proceed as follows:

(1) Keep the data selector <2> depressed while switching on the power
switch <6>.
(2) Select the desired parameter with the data selector <2> and confirm.
(3) Set the desired value of the parameter. Modifications can be recognised
immediately by means of acoustic or visual signals.
(4) Exit the basic settings.
The selected settings are immediately valid.

8.1 Setup Menu

The setup menu serves to change some parameters without having to switch the
device off and on.

The following parameters can be modified:

LCD contrast

Acoustic coupling confirmation

Quit setup menu

To modify a parameter, proceed as follows:

(1) Choose SET on the display <1>.
(2) Select the desired parameter with the data selector <2> and confirm.
(3) Set the desired value of the parameter. Modifications can be recognised
immediately by means of acoustic or visual signals.
(4) Exit the setup menu.
The selected settings are immediately valid.

20 PHYSIOSON-Basic
 General Notes

9 General Notes
The instrument may only be operated in dry rooms designed for medical purposes,
in accordance with VDE 0107, User Class 1. These include rooms with patient beds,
physical therapy rooms and practice rooms.
The instrument may only be operated by qualified personnel who have undergone
special training!
It complies with the technical specifications of IEC 601, VDE 0750 and is assigned to
class IIa according to the Council Directive concerning Medical Devices.
It is not intended for operation in explosion hazard zones or hydrotherapy rooms.
Drastic temperature changes should be avoided, since condensation could be
caused within the instrument. Do not start up the instrument until it is in
temperature equilibrium with its environment!
The instrument is to be operated properly, i.e. in accordance with the Operating
Instructions.
During operation, ultrasonic waves are emitted by the instrument. Please consider
this exposure in its environment.

10 Service, Repairs, Maintenance

The manufacturer is only obliged to guarantee the safety features of the instrument
in its original state.
The instrument must be operated in accordance with the Operating Instructions.
Repairs to the instrument may only be performed by parties duly authorised by
PHYSIOMED ELEKTROMEDIZIN AG. Any repairs performed by an authorised agent
must be accompanied by written certification, describing the nature and extent of
the repairs undertaken, as applicable with details regarding changes to nominal
operating values or the operational range. The certification must also contain the
date performed, the name of the repair company and the signature of the
repairman.
When defective, components affecting the safe operation of the instrument must be
replaced by manufacturer’s original parts.
Upon request, wiring diagrams, parts lists and service instructions can be made
available to qualified technical personnel employed by the customer.
We recommend having the instrument, including all accessories, serviced at regular
intervals. Please refer to the Manufacturer Recommendations (page 25) for the
safety regulations control. We especially recommend checking the following
components at regular intervals:
• the ultrasonic transducer for cracks, through which water might penetrate into
the instrument
• the leads of the ultrasonic transducers and the corresponding connectors

PHYSIOSON-Basic 21
Cleaning and Disinfection

11 Cleaning and Disinfection

Clean the device and the accessories regularly with an aldehhyde-based disinfectant.
Prior to cleaning, switch off the instrument and disconnect the power lead.
Use a soft sponge cloth for cleaning. Be careful that no liquid substances invade the
instrument.
After treatment always remove remaining ultrasound gel from the transducers.
Clean the transducers regularly with an aldehhyde-based disinfectant. Disconnect
the transducer from the unit.

Note 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!

12 Connecting a Stimulation Current Unit

PHYSIOSON-Basic can be used for simultaneous therapy together with an
appropriate stimulation current unit.
For further notes refer to section Simultaneous Therapy on page 14.

22 PHYSIOSON-Basic
 Technical data

13 Technical data
Protection class I acc. to VDE 0750 / IEC 601
Type: BF

CE characterisation acc. to Council Directive concerning medical devices

93/42 EEC

Class acc. to EC 93/42 IIa

Mains connection 100 - 240 VAC

Do run the instrument only with the indicated
operating voltage!

Power line frequency 50 -60 Hz

Power line input 60 VA

Line fuses at 230 V: T 500 mA

Output data small transducer large transducer

ERA 2.5 cm² 4 cm²

BNR <5 <5
US frequency 1 MHz 1 MHz
Maximum output 7.5 W 12 W
eff. Output power 5W 8W
Average power density 3 W/cm² 3 W/cm²
Collimator type diverging collimating

Modulation cont. (continuous)

0 ...(0.5...2.0) W/cm² =
cont. 100 Hz
(0.5....2.0)...3.0 W/cm² =
2/5
- 1 / 10 100 Hz
-1/5 100 Hz
-1/3 100 Hz
-2/5 100 Hz

Ambient temperature + 10°C ... +40°C

Dimensions 31.5 x 10.4 x 28.5 cm

(W x H x D)

Weight 2.2 kg (mains operated model)

3.1 kg (battery operated model)

PHYSIOSON-Basic 23
Accessories

14 Accessories

14.1 Standard Accessories

Ref.-No. Description Number

00776 Mains cable 1
00575 Transport bag (only for battery operated model) 1
00183 Ultrasound gel 1
00076 Ultrasound transducer 2.5 cm2, 7-pole
1 (out of two)
00077 Ultrasound transducer 5 cm2, 7-pole
00929 Operating Instructions (English) 1
00626 Instructions for Ultrasound Therapy (English) 1

For safety reasons, PHYSIOSON-Basic is to be used exclusively with original accessories.

The use of other manufacturers' accessories is at the user's risk.

14.2 Additional Accessories

Ref.-No. Description
00164 Connection cable (electrotherapy/ultrasound)
00184 Filling pump
00775 Mains cable
01001 Trolley Universal
01003 Trolley Universal II
01005 Trolley Universal III
00180 Ultrasound gel
00182 Ultrasound gel
00076 Ultrasound transducer 1MHz 2,5cm2
00177 Ultrasound transducer holder

24 PHYSIOSON-Basic
 Manufacturer’s Recommendations

15 Manufacturer’s Recommendations

MANUFACTURER’S RECOMMENDATIONS
SAFETY REGULATIONS CONTROL
according to Medical Devices Directive

UNIT: PHYSIOSON-Basic

MANUFACTURER: PHYSIOMED ELEKTROMEDIZIN AG

Instrument has to undergo a safety regulation control every 18 months.

EXTENT:

1. Visual inspection of the instrument, extras and accompanying papers

2. Functional testing of instrument and accessories

3. Check of output parameters

4. Visual inspection of the ultrasonic transducers for cracks

5. Visual inspection of the ultrasonic transducer leads and connectors

6. Electrical safety according to VDE 0751

Limiting value according Value first measured

to VDE 0751 (new apparatus)

6.1 Earth-conductor resistance

(including lead 3 m) 0.3 Ohm 0.150 Ohm

6.2 Substitute device leakage current

1 mA 0.700 mA

6.3 Substitute patient leakage current

5 mA 0.100 mA

PHYSIOSON-Basic 25
Index

16 Index

contraindications 2 simultaneous therapy 2, 14

controls 3 status bar 3, 5
coupling confirmation 6, 12, 13, 17 stimulation current 2, 14
current mode 5, 18 stimulation current unit 23
data selector 3, 5, 20 therapy mode 12
display 3 therapy time 6, 12, 13
dose control 19 timer 6, 13, 17, 19
front panel 2 transducer 11, 12, 16, 19
function check 11 transducers 5
indications menu 12, 16 ultra sound 2
indicators 3 ultra sound therapy 1
new apparatus 26 ultrasonic transducer 11
setup menu 21 ultrasound 12, 14
SIM socket 6 ultrasound gel 12, 17, 19

26 PHYSIOSON-Basic