GBO Stereodynator 928 User manual

Interference Current Stimulation Devices

STEREODYNATOR 928

User Manual

 gbo Medizintechnik AG 2004 Version 1.9

STEREODYNATOR



928

Das vorliegende Handbuch wurde von der gbo Medizintechnik AG erstellt und auf seine Richtigkeit überprüft. Es erhebt jedoch keinen Anspruch auf Vollständigkeit. Alle Angaben und Daten können ohne vorherige Ankündigung geändert werden.

Ohne ausdrückliche schriftliche Genehmigung der gbo Medizintechnik AG darf kein Teil dieses Handbuch für irgendwelche Zwecke vervielfältigt oder übertragen werden, unabhängig davon, auf welche Art und Weise oder mit welchen Mitteln, elektronisch oder mechanisch, dies geschieht.

The gbo Medizintechnik AG has taken care in preparation of this manual, but makes no expressed or implied warranty of any kind and assume no responsibility for errors or omissions.

gbo Medizintechnik AG Kleiststraße 6

D-64668 Rimbach

Telephone:+49 / 6 25 3 / 808-0 Telefax: +49 / 6 25 3 / 808-300 E-Mail: info@gbo-med.de Internet: http://www.gbo-med.de

 gbo Medizintechnik AG 2004 Version 19

STEREODYNATOR



928

Comments According to the Medical Device Directive

The STEREODYNATOR 928 is a mains operated current stimulation device of protection class I.

The device is in accordance with the EC Medical Device Directive (93/42/EEC) and therefore carries the CE-sign with the number of the ”notified body for medical devices”. The according graphical symbol is placed on the type plate.

According to the Medical Device Directive, STEREODYNATOR 928 is a device of class IIb.

The manufacturer is only responsible for the security, operational reliability and functionality of the device if:

• the device is used in accordance with the user manual;

• the electrical installation of the location where the device will be used corresponds to the

respective current requirements of electrical safety;

• the device is not used in hazardous environments and humid locations;

• the mountings, add ons, internal adjustments, modifications or repairs are realized only by

personnel authorized for that by the manufacturer;

• the operator regulation of this EC-directive is observed within the scope of the Medical Device

Directive.

You may obtain technical support by the manufacturer or the dealers or service authorized by the manufacturer. The manufacturer provides a life time of at least 10 years for this product.

STEREODYNATOR 928 is a

electronic device. Disposing has to be done according to regulations

for electronic devices. Consumables have to be disposed as garbage.

On request, the manufacturer will provide you with further technical descriptions for all serviceable parts of the device, such as circuit diagrams, spare part lists, and adjustment instructions as far as these are of use for the qualified technical staff of the user.

Comments on electromagnetic compatibility (EMC)

Medical, electrical devices are subject to special precautions concerning the EMC. They must be installed and operated according to the EMC-advice given in the accompanying documents. In particular medical, electrical devices may be influenced by portable and mobile RF-communication devices.

The manufacturer guarantees the conformity of the unit with the EMC-requirements only when using accessories which are listed in the EC declaration of conformity. The usage of other accessories my cause an increased emission of electromagnetic disturbances or may lead to a reduced electromagnetic immunity.

The unit must not be arranged physically close to other devices or stacked with them. If such an order is necessary nevertheless, the unit must be observed in order to check it for the intentional operation.

You find more EMC-comments in the chapter “Warnings and Safety Precautions” of this manual as well as in the Technical Information on the next two pages.

 gbo Medizintechnik AG 2004 Version 1.9

STEREODYNATOR



928

In accordance with the EMC-regulations for medical products we are obliged by law to provide the following information.

Guidance and manufacturer’s declaration — electromagnetic emissions

The equipment is intended for use in the electromagnetic environment specified below. The customer or the user of the equipment should assure that it is used in such an environment.

Emissions test Compliance Electromagnetic environment – guidance

RF emissions, CISPR 11

RF emissions, CISPR 11 Harmonic emissions, IEC 61000-3-2 (*) Voltage fluctuation/flicker emissions, IEC 61000-3-3 (*)

(*) Note: For devices with a power consumption between 75 W and 1000 W only.

Guidance and manufacturer’s declaration — electromagnetic immunity

The equipment is intended for use in the electromagnetic environment specified below. The customer or the user of the equipment should assure that it is used in such an environment.

Immunity test IEC 60601- test level Compliance level Electromagnetic environment –

Electrostatic discharge (ESD), IEC61000-4-2

Electrical fast transient/burst, IEC 61000-4-4

Surge, IEC 61000-4-5

Voltage dips, short interruptions and voltage variations on power supply input lines, IEC 61000-4-11

Group 1 The equipment uses RF energy only for its internal function.

Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

Class B

Class A

Complies

The equipment is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

guidance

±6 kV contact

±8 kV air

±2 kV for power supply

lines

±1 kV for input/output lines

±1 kV differential mode

±2 kV common mode

<5% U

for ½ cycle (>95% dip)

40% U

for 5 cycles 60% dip)

70% U

for 25 cycles 30% dip)

±6 kV contact

±8 kV air

±2 kV for power supply

lines

±1 kV for input/output lines

±1 kV differential mode

±2 kV common mode

<5% U

for ½ cycle (>95% dip)

40% U

for 5 cycles 60% dip)

70% U

for 25 cycles 30% dip)

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %. Mains power quality should be that of a typical commercial or hospital environment.

Mains power quality should be that of a typical commercial or hospital environment.

If the user of the equipment requires continued operation during power mains interruptions, it is recommended that the equipment be powered from an uninterruptible power supply or a battery.

<95% U for 5 s (>5% dip)

Power frequency (50/60 Hz) magnetic field, IEC 61000-4-8

Note: Uτ is the a.c. mains voltage prior to application of the test level.

 gbo Medizintechnik AG 2004 Version 19

3 A/m 3 A/m Power frequency magnetic fields should

<95% U for 5 s (>5% dip)

be at levels characteristic of a typical location in a typical commercial or hospital environment.

STEREODYNATOR



928

Guidance and manufacturer’s declaration — electromagnetic immunity

The equipment is intended for use in the electromagnetic environment specified below. The customer or the user of the equipment should assure that it is used in such an environment.

Immunity test IEC 60601- test level Compliance level Electromagnetic environment –

guidance

Portable and mobile RF communications equipment should be used no closer to any part of the equipment, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance:

Conducted RF, IEC 61000-4-6

Radiated RF, IEC 61000-4-3

3 V

rms

150 kHz to 80 MHz 3 V/m

80 MHz to 2,5 GHz

3 V

3V/m

eff

d=1,2√P

d=1,2√P for 80 MHz to 800 MHz d=2,3√P for 800 MHz to 2,5 GHz Where P is the maximum output power rating of the transmitter in watts according to the transmitter manufacturer and d is the recommended separation distance in meters (m).

Interference may occur in the vicinity of equipment marked with the following symbol:

Recommended separation distances to portable and mobile RF communication equipment

The equipment is intended to be operated in an electromagnetic environment, where radiated RF interference is controlled. The user can help in avoiding interferences by means of meeting minimum separation distances between portable and mobile RF communication equipment (transmitters) according to the maximum output power of the communication equipment.

Separation distance according to the tranmission frequency (m)Rated power of the

transmitter (W)

0,01 0,12 0,12 0,23

0,1 0,38 0,38 0,73

1 1,2 1,2 2,3

10 3,8 3,8 7,3

100 12 12 23

150 kHz to 80 MHz

d=1,2√√√√P

80 MHz to 800 MHz

d=1,2√√√√P

800 MHz to 2,5 GHz

d=2,3√√√√P

 gbo Medizintechnik AG 2004 Version 1.9

STEREODYNATOR



928

EC - DECLARATION OF CONFORMITY

Name of manufacturer : gbo Medizintechnik AG

Address : Kleiststrasse 6

D - 64668 Rimbach Germany

We hereby declare under our sole responsibility that the product described below conforms in design and make as well as in the versions delivered to the corresponding safety and protection requirements defined in the applicable EC regulations.

Harmonized standards have been used for all conformity checks, national standards have not been applied.

Any change to the product design that is not validated by us will render this declaration invalid.

Type of product : Stimulation Current Unit

Label :

STEREODYNATOR 928 Part-No. 014-0-928

Options : Ultrasound therapy module Part-No. 014-0-928-U

Suction application module Part-No. 014-0-928-V

Accessories :

Description Part-No.

Bow electrode 011-0-0024 Handle with finger-tip 45-38-401EH725 Rubber electrode 3 x 4 cm Rubber electrode 6 x 8 cm Rubber electrode 8 x 12 cm Tin plate electrode 9 x 12 cm Patient cable 45-38-435EH725 Suction electrode 34 mm 45-38-518EH722 Suction electrode 70 mm 45-38-526EH722 Suction electrode 50 mm 45-38-500EH722 Ultrasound probe 2,5 cm Ultrasound probe 5 cm Vaginal electrode 014-0-0006 Rectal electrode 014-0-0007 Star electrode small 45-38-708EH725 Star electrode standard 45-38-716EH725 Star electrode large 45-38-724EH725 Stereo suction electrode 45-38-856EH722

45-38-880EH725 45-38-898EH725 45-38-492EH725 45-38-468EH725

023-0-0140 023-0-0141

Corresponding EC regulations : EC medical devices directive (93/42/EEC)

Conformity assessment

procedure : Annex II of the directive 93/42/EEC

Classification : IIb (according to MDD, appendix IX)

Name und registration no.

of the notified body : TÜV Product Service in Munich/Germany with the

registration no. 0123

Additional information : none

Date :

January-1, 2006

Name of persons responsible : Dr. Eberhard Keck

Title/Function : CEO

Signature :

 gbo Medizintechnik AG 2004 Version 19

STEREODYNATOR



928

Notations

Times New Roman in type size 11 - descriptions and explanations

Arial in type size 10

Lucida in type size 11 - text appears on the display of the current stimulation device

[[[[Descriptions]]]]

- functions and keys of the current stimulation device

- text appears on the display next to the soft key

Pictographs

Attention

Warnings which have to be observed by all means !

Attention !

Observe the instructions for use !

!! Note Information that will facilitate your work.

 gbo Medizintechnik AG 2004 Version 1.9

STEREODYNATOR



928

Table of Contents

OVERVIEW 11

1 INTRODUCTION 12

1.1 Intended Use 12

1.2 Operating Concept 14

1.3 Short Instructions 15

1.4 Modes of Action of the Therapeutic Current Types 17

2 START OF OPERATION 18

2.1 Transport and Assembly 18

2.2 Connection and Switch-On 18

2.3 Settings 19

2.3.1 Device Settings 19

2.3.2 Basic Settings of the Current Types 20

3 DESCRIPTION OF FUNCTION 21

3.1 Operating Notes 21

3.1.1 Optical and Acoustical User Support 21

3.1.2 Intensity Regulator 22

3.1.3 Current and Polarity 22

3.1.4 Surge Parameters 24

3.1.5 Galvanic Base 24

3.1.6 Frequency Lock 24

3.1.7 Pulse Parameter 25

3.1.8 Therapy Time 25

3.1.9 Stimulation shifting 26

3.1.10 Menu 27

3.1.11 Menu Programs 28

3.2 Integrated Suction Application Aid 29

3.3 Ultrasound Therapy Module 30

4 THERAPY 32

4.1 Therapy with interference currents 32

4.1.1 Sedat 32

4.1.2 Myomot 33

4.1.3 Vegetative Stimulation I 33

4.1.4 Vegetative Stimulation II 33

4.1.5 Vegetative Stimulation III 33

4.1.6 Universal 33

4.1.7 Sedation Modulation 33

4.1.8 Automated programs 34

4.2 Menu Application With Electrotherapy 35

4.3 Menu ‘Applications with ultrasound’ 36

4.4 ”One - Touch” - Operation 36

4.4.1 Diadynamic Currents 36

4.4.2 Strong Muscle Stimulation (SMS) According to Eichhorn 37

4.4.3 Middle Frequency Currents 37

4.4.4 Ultrastimulation Current 38

 gbo Medizintechnik AG 2004 Version 19

STEREODYNATOR

4.4.5 High-Voltage Currents 38

4.4.6 Galvanic Current and Iontophoresis 39

4.4.7 Faradic Current 40

4.4.8 Transcutaneous Electrical Nerve Stimulation 40

4.4.9 Transcutaneous Electrical Nerve Stimulation With Impulse Groups 41

4.4.10 Micro-Stimulus Current 42

4.4.11 Universal Therapy 42

4.5 Special types of current Menu 42

4.5.1 Impulse Galvanization 43

4.5.2 Frequency Modulation 43

4.5.3 Diadynamic Currents MF Monophasé Fixe and LP Longues Périodes 43

4.5.4 Rectangular Current for Incontinence 43

4.6 GYM 44

4.6.1 GYM current 44

4.6.2 GYM Training 45

4.6.3 Burning mode 45



928

5 GALVANOPALPATION 46

6 ELECTROKINETIC THERAPY 47

6.1 Detection of Trigger Points With the Electrode Handpiece 47

6.2 Stimulation Massage 47

7 ELECTRODES 48

7.1 Electrode Positioning 48

7.1.1 Monophase Electrode Techniques 49

7.1.2 Biphase Electrode Techniques 49

7.2 Single-Pole Electrodes 49

7.3 Three-pole electrodes 51

7.4 Suction Electrodes 51

7.4 Suction Electrodes 52

7.5 Electrode Handpiece 52

8 TROUBLESHOOTING 53

9 MAINTENANCE 54

9.1 Safety Controls 54

9.2 Cleaning, Disinfection and Care 54

9.2.1 Current Stimulation Device 54

9.2.2 Electrode Fleece, Electrode Pockets or Felts 54

10 WARNINGS AND SAFETY PRECAUTIONS 55

11 EXPLANATION OF THE SIGNS USED 57

12 TECHNICAL DATA 58

13 ACCESSORIES 61

INDEX 57

 gbo Medizintechnik AG 2004 Version 1.9

STEREODYNATOR



928

APPENDIX: STORING OF THERAPEUTIC CURRENT TYPES 59

 gbo Medizintechnik AG 2004 Version 19

STEREODYNATOR



928

Overview

Chapter 1 describes the basic characteristics of the current stimulation device.

Chapter 2 explains the start of operation of the current stimulation device. It describes its setting

possibilities.

Chapter 3 describes all functions of the device and their operation.

Chapter 4 explains the realization of therapies.

Chapter 5 explains the realization of galvanopalpation.

Chapter 6 explains the realization of electrokinesis.

Chapter 7 refers to the arrangement and the use of the electrodes.

Chapter 8 explains the error messages and gives some hints in the case of faults.

Chapter 9 refers to safety controls in accordance with the MDD and to routine maintenance.

Chapter 10 shows the possible threats when using the current stimulation device. Furthermore, it

indicates how to avoid possible threats.

Chapter 11 explains the signs used.

Chapter 12 speifies all relevant technical data of the current stimulation device.

Chapter 13 shows the scope of supply of the device and informs about further accessories indicating

their order number.

 gbo Medizintechnik AG 2004 Version 1.9

STEREODYNATOR



928

1 Introduction

1.1 Intended Use

The devices with interference current are microprocessor controlled electrical stimulus devices for Electro Therapy. Their wide range of usage predestinates these medical devices for use in physiotherapeutic departments of clinics as well as in modern well-equipped private practices.

The devices with interference current represent a continued development, based on the 8 All accessories of the 8

series can also be used with the 9th generation in the same manner. A suction

series equipment.

application aid for vacuum therapy as well as a module for ultrasound therapy with continuous and impulse ultrasound waves are optionally available. The control elements for suction application aid and ultrasound have already been integrated on the keyboard.

A stereodynamic interference current is generated through the superposition of three middle-frequency currents flowing in different directions. The stimulating lower frequencies are already generated through interference of two phase shifted circuits in the area being stipulated. The additional third circuit generates, as opposed to classical interference methods, on one side a slow change in intensity and on the other side a rhythmic shifting of the interference field. These dynamics of the stimulation location and the intensity dynamics decrease the habituation effect and therefore improve the therapeutic effect. The STEREODYNATOR 928 uses the three-dimensional interference method. The special characteristics are as follows:

• Local stimulation effect.

• Multi-site stimulation effect.

• Intensity dynamics.

• Dynamic behavior of stimulation site coupled with endogenous/exogenous stimulation shifting.

Automated programs improve the handling: The STEREODYNATOR 928 is equipped with several programs which automatically adjust the treatment frequency and the treatment time. Treatment frequencies, particularly for sedation, myokinetics and vegetative stimulation, are available.

The stimulating effect can alternatively be administrated endogenously or exogenously. During endogenous application, the interference is generated through superposition of the electrical circuits in the body. This allows an intense effect. During exogenous application, the interference is created in the medical device. The stimulating effect takes place directly underneath the electrodes on the body surface.

In addition to the three-circuit interference current, STEREODYNATOR 928 offers a complete selection of single circuit currents for all known therapeutic procedures.

 gbo Medizintechnik AG 2004 Version 19

STEREODYNATOR



928

The STEREODYNATOR 928 is particularly suitable for:

• Pain therapy with three-dimensional interference current.

• Muscle toning and muscle detoning.

• Galvanization and iontophoresis.

• Pelvic floor stimulation.

• Treatment of urinary and fecal incontinence.

• Neurodiagnostic examination with galvano-palpations.

• Treatment of paralyses with complete or partial muscular degeneration.

• Treatment of atrophies due to inactivity or weakened muscles after longer periods of inactivity.

• Electrical stimulation therapy without electrolytic side effects and only slight muscle fatigue.

• Treatment of pain, muscle spasms, functional diseases of the locomotor system, such as sports injuries,

peripheral circulatory disturbances, influencing of the vegetative system with diadynamic currents, ultrastimulation current, microstimulation current, TENS- and TENS Burst currents, high-voltage currents and middle-frequency currents.

 gbo Medizintechnik AG 2004 Version 1.9

STEREODYNATOR



928

1.2 Operating Concept

”One-Touch”-Philosophy

Immediately after pushing the key for the desired current type, the therapy or diagnosis can be started.

Ergonomic Control Panel

Function keys are colored black and modification keys are white. Keys for identical functions on different models are located in the same position on all devices. They are easy to recognize – which is particularly important for the visually handicapped - and also have a pressure point. The parameter settings can be carried out with keys or the modification knob.

The

modification knob has an upper and lower limit stop by software. So the values can only be modified

in a defined range of values even by overturning the knob. The according limit stop can be equipped with a signal tone with the device setting, see chapter 2.3.1 .

In case of key operating there is no limit stop; after the last setting possibility it will restart with the first one. Here it is also possible to have a key click by the appropriate device setting, see chapter 2.3.1.

After the expiration of the therapy time, the current to the patient automatically is switched off and the intensity

is set to ”0.0”.

Display

All devices are equipped with a high-resolution graphic display. The selected stimulation current type is shown graphically. The parameters are also shown. They are modified using the white modification keys located around the display or by the modification knob.

LED keys

Optical user support is furnished in the form of LED lights incorporated into the keys:

∗ flashing - ∗ constantly lit - ∗ not lit -

key was selected and remains active key is active and operational key is not active and not operational

In addition to the ”One-Touch” operation, a user-guided method for selection can also be chosen by way of the menu. By selecting the desired effect (analgesia, hyperemia, muscle toning, muscle detoning) and the site of action (head and neck, spinal column and trunk, upper extremities, lower extremities), the appropriate current type is automatically selected and a recommendation for the electrode application is provided. The menu also allows the use of special types of current.

 gbo Medizintechnik AG 2004 Version 19

STEREODYNATOR

)



928

1.3 Short Instructions

Galv. base Operation mode

Therapy time Graphic display Menu Polarity

Types of therapy stimulation currents

Frequency lock Soft key

mono-/biphase pulse rise

End./ex. change

Stereodynamic interference currents

Stim. frequency

Ultrasound therapy unit* Pulse-/Pause Modification- Suction aid for- Intensity knob

Patient cable connection and/or vacuum cable I = socket (1)

Vacuum cable II = socket (2)

depending on unit configuration

Application part ungrounded, protection BF

Service interface

duration knob vacuum therapy*

Surge parameter

ttention! Observe the instructions for use !

Carrying

Connection for ultrasound probe = socket (3

Power inlet Fuses and voltage

selector

Mains switch

handle

Automatic programs

Figure 1: STEREODYNATOR 928

 gbo Medizintechnik AG 2004 Version 1.9

STEREODYNATOR



928

1. Switch on with the mains switch at the back of the device. The device carries out an automatic test of all its functions. The faultless selftest ends with the acoustic signal.

2. Connect the accessories with the according socket on the right side of the device.

3. Optical user support is furnished in the form of LED lights incorporated into the keys:

∗ flashing - ∗ constantly lit - ∗ not lit -

key was selected and remains active key is active and operational key is not active and not operational

4. The three-ray star display serves as stimulation frequency display and electrode contact display. The green luminous bars are lit in the three circuit mode and show the frequencies effective in the body. The red LEDs indicate:

∗ Red LEDs lit - there is current flowing ∗ Red LED not lit - there is no current flowing

5. Furthermore, an acoustic user support is furnished

∗ Confirmation beep 1 x - admissible pressing of a

key

∗ Information sound 1 x - inadmissible pressing of a key

- disconnection of the patient plug during operation

∗ Alarm ca. 2 s - insufficient electrode contact, dropping electrodes during the

- therapy (

- in case of unintended current increase during therapy

CC)

∗ Triad-gong 1 x - at the beginning of the automatic check to control the gong

3 x - at the end of therapy

- the key of the electrode handpiece has not been pressed for 2 min

- in operating mode CV no current has flown for 2 min

6. Put the electrodes on to the patient (exception: in case of using the suction application aid the

key

and the Types of stimulation current key have to be pressed first).

Vacuum

7. Select the current type by pressing the corresponding current key or select it from the Menu.

8. The default setting of the current type is activated automatically.

9. Select additional modifications:

• By pressing the desired

• By turning the

Modification knob or repeatedly pressing of the Modification key until the desired

Modification key.

value has been set.

10. Increase the current slowly with the

Intensity regulator until the desired stimulation effect occurs.

11. At the end of the therapy the triad gong will sound three times. The current to the patient will be faded out within 10 s.

 gbo Medizintechnik AG 2004 Version 19

STEREODYNATOR



928

1.4 Modes of Action of the Therapeutic Current Types

Current

Galvanic current

Ultrastimulation current

Faradic current

Strong muscle stimulation

Micro-stimulus current

Universal therapy

Diphasé fixe

Courtes périodes

MF I / surged

MF II / sinus surged

MF III / 50 Hz

Key Grafics I II III IV

Galv

SMS

Micro

MF...

Current

Tens Burst I / 50 Hz

Tens Burst II / 3 - 10 Hz

Tens Burst III / 10 - 30 Hz

Tens Burst IV / 30 - 60 Hz

Tens Burst V / 100 - 200 Hz

Special currents

Monophasé fixe MF

Longues périodes LP

Impulse galvanization IG 30 Impulse galvanization IG 50 / surged Frequency modulation FM / 7 - 14 Hz

Key Grafics I II III IV

Te ns Burst...

MF IV / 3 - 10 Hz

MF V / 10 - 30 Hz

MF VI / 30 - 60 Hz

MF VII / 100 - 200 Hz

HV I / 50 Hz

HV II / 3 -10 Hz

HV III / 10 - 30 Hz

HV IV / 30 - 60 Hz

HV V / 100 - 200 Hz

Tens I / 100 Hz

Tens II / 3 - 10 Hz

Tens III / 10 - 30 Hz

Tens IV / 30 - 60 Hz

Tens V / 100 - 200 Hz

HV...

Ten s. ..

Incontinence

Stereodynamic Interference currents

Sedat 200 Hz

Myomot 50 Hz

Vegetat. Stim I

2.5 - 25 Hz

Vegetat. Stim II 10 Hz

Vegetat. Stim III

0.1 - 1 Hz

Universal 1 - 200 Hz

…

With depth effect

No effect Good effect Slight effect Very good effect

I Analgesia III Muscle toning II Hyperämia IV Muscle detoning

Table 1:Modes of action of the therapeutic current types

 gbo Medizintechnik AG 2004 Version 1.9

STEREODYNATOR



928

2 Start of Operation

2.1 Transport and Assembly

The current stimulation device is a portable unit. There is a carrying handle in the form of a recessed grip in the base plate. To place the unit, each flat surface is appropriate. A wall distance of at least 20 cm has to be provided. The device should not be placed in front of radiators.

The current stimulation device corresponds to the regulations DIN/VDE 0750, EN 60601. It is a device of protection class I. Within the scope of the Medical Device Directive (MDD) the current stimulation device belongs to class IIb (see also chapter 10 Warnings and Safety Precautions).

Attention

The unit is not designed to be operated in places with the inherent risk of explosions. If it is used in dangerous areas of anesthesia departments, the possibility of an explosion cannot be excluded.

If the patient and/or the patient cable is directly exposed to a radiator of a medical device for high frequency heat therapy, the damage of the device or a danger to the patient cannot be excluded. As a rule, a distance of 3 m is sufficient.

2.2 Connection and Switch-On

The current stimulation device has been adjusted for the connection to a supply voltage of 230 V. If needed, the device can be switched over to the following supply voltages:

• 240 V

• 230 V

• 120 V

• 100 V.

Irrespective of the adjusted supply voltage, the device is appropriate for mains frequencies of 48 to 62 Hz.

Voltage Selection and Fuses:

1. Unplug the mains plug.

2. The device is protected by 2 fuses on the mains side that are located in a pluggable box at the back of the

device next to the power inlet (see Figure 1).

3. The adjusted supply can be seen through the small window of the box.

4. With a screw driver the box can be pulled out of the line filter unit by the small slot.

5. Remove the voltage selector out of the holder and set the usual supply voltage.

 gbo Medizintechnik AG 2004 Version 1.9

STEREODYNATOR

g p



928

Attention

The mains socket has been sealed with a scotch tape. This is to remember to check prior to switch-on, whether the adjusted voltage corresponds to the supply voltage of the treatment room.

The scotch tape over the mains socket is easy to remove. Connect the current stimulation device with the mains cable to a (grounded) safety power outlet.

The current stimulation device is switched on by the mains switch at the back of the device. By this arrangement erroneous, unintended disconnection of the device during normal operations shall be avoided.

After switching on the device, an automatic selftest of all device functions will be performed (see chapter

1.3 Short Instructions).

2.3 Settings

2.3.1 Device Settings

Once the unit has been switched on and is ready, you can start immediately with the standard settings.

Device settin

Signal for adjustment knob Signal for keys yes / no yes Max. value of therapy time 20 min / 40 min 20 min Ultrasound power emission W / W/cm Automatic pump switch off yes / no Yes Signal volume bargraph 0 - 15 7 Language German

Contrast of display 0 - 15 7 Inverse representation yes / no No Display mode of action yes / no yes Therapy time adjustment 1 min – max. value standard Vacuum default intensity 0 % - 100 % 0 %

sSettin

es / no

English Italian Portuguese Spanish Czech French

ossibilities Deliver

W/cm

German

Table 2: Device settings

 gbo Medizintechnik AG 2004 Version 1.9

If you would like to change them, please proceed as follows:

1) Press the black

2) You are in the Main menu.

3) Move the scroll bar with the

4) Confirm by pressing the white

5) You are in the Device settings menu.

6) Move the scroll bar with the

7) Confirm by pressing the white

8) Move the cursor with the

9) Confirm by pressing the white

10) Exit the Device settings menu by pressing the black

11) On the display the Main menu appears again.

Menu key.

Modification knob to Device settings.

Soft key.

Modification knob to the device setting to be changed.

Soft key.

Modification knob to the desired value.

Soft key.

Menu key.

STEREODYNATOR

!! Note

On Vacuum default intensity setting the pump is switched off, if no suction electrodes are connected. If suction electrodes are connected the pump will run corresponding to the set value.



928

2.3.2 Basic Settings of the Current Types

Upon pressing the desired current type key, the default settings for this current type are set. Altered parameters are canceled by pressing the current type key again, i.e. the default settings are available again. Modifications will not be stored.

!! Note

If the default settings for the therapy time have been modified by therapy time adjustment, the new settings are permanently stored and recalled each time after pressing the current type key.

 gbo Medizintechnik AG 2004 Version 1.9

+ 46 hidden pages

GBO Stereodynator 928 User manual

Specifications and Main Features

Frequently Asked Questions

User Manual