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HiToP BodyBeauty 172 - gbo Medizintechnik

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HighTone Power Therapy Device<br />

<strong>HiToP</strong> ®<br />

<strong>BodyBeauty</strong> <strong>BodyBeauty</strong> <strong>172</strong><br />

User manual<br />

© <strong>gbo</strong> <strong>Medizintechnik</strong> AG 2004 Version 1.3


2 <strong>HiToP</strong> ® <strong>BodyBeauty</strong> <strong>172</strong><br />

Das vorliegende Handbuch wurde von der <strong>gbo</strong> <strong>Medizintechnik</strong> AG erstellt und auf seine Richtigkeit<br />

überprüft. Es erhebt jedoch keinen Anspruch auf Vollständigkeit. Alle Angaben und Daten können ohne<br />

vorherige Ankündigung geändert werden.<br />

Ohne ausdrückliche schriftliche Genehmigung der <strong>gbo</strong> <strong>Medizintechnik</strong> AG darf kein Teil dieses Handbuchs<br />

für irgendwelche Zwecke vervielfältigt oder übertragen werden, unabhängig davon, auf welche Art und<br />

Weise oder mit welchen Mitteln, elektronisch oder mechanisch, dies geschieht.<br />

The <strong>gbo</strong> <strong>Medizintechnik</strong> AG has taken care in preparation of this manual, but makes no expressed or<br />

implied warranty of any kind and assumes no responsibility for errors or omissions.<br />

All rights reserved. No part of this manual may be reproduced in any form or by any means (electronic,<br />

mechanical, or otherwise) without the prior written permission of the <strong>gbo</strong> <strong>Medizintechnik</strong> AG.<br />

© <strong>gbo</strong> <strong>Medizintechnik</strong> AG 2004<br />

<strong>gbo</strong> <strong>Medizintechnik</strong> AG<br />

Kleiststrasse 6<br />

D-64668 Rimbach<br />

Phone: +49 6 25 3/808-0<br />

Fax: +49 6 25 3/808-300<br />

E-Mail: info@<strong>gbo</strong>-med.de<br />

Internet: http://www.<strong>gbo</strong>-med.de<br />

© <strong>gbo</strong> <strong>Medizintechnik</strong> AG 2004 Version 1.3


<strong>HiToP</strong> ® <strong>BodyBeauty</strong> <strong>172</strong><br />

Notes in accordance with EC directive and Medical<br />

Devices Directive (MDD)<br />

The <strong>HiToP</strong> ® <strong>BodyBeauty</strong> <strong>172</strong> is a line-powered device for HighTone Power Therapy of protection class I.<br />

The device is in accordance with the EC directive for medical devices (93/42/EWG) and therefore carries<br />

the CE sign with the registration number of the notified body for medical devices. The according graphical<br />

symbol is placed on the type plate.<br />

According to the MDD, <strong>HiToP</strong> ® <strong>BodyBeauty</strong> <strong>172</strong> is a class IIa device.<br />

The manufacturer is only responsible for the safety, operational reliability and functionality of the device if:<br />

• the device is used in accordance with the instructions for use;<br />

• the electrical installation of the location where the device will be used meets the respective current<br />

requirements of electrical safety;<br />

• the device is not for use in hazardous environments and humid locations;<br />

• mountings, amplifications, re-adjustments, modifications or repair works are carried out only by<br />

personnel authorized by the manufacturer;<br />

• the operator regulation of this EC directive is observed within the scope of MDD.<br />

Technical support may be obtained by the manufacturer, dealers or service authorized by the manufacturer.<br />

The product’s duration of life as scheduled by the manufacturer is 10 years.<br />

<strong>HiToP</strong> ® <strong>BodyBeauty</strong> <strong>172</strong> is an electronic device. For its disposal the according regulations for electronic<br />

devices have to be observed. Incidentals have to be disposed with residual waste.<br />

On request, the manufacturer will provide you with further technical descriptions for all repairable parts of<br />

the device, such as circuit diagrams, spare parts lists, and adjustment instructions as far as these are<br />

necessary for the qualified technical staff of the operator.<br />

Comments on electromagnetic compatibility (EMC)<br />

Medical, electrical devices are subject to special precautions concerning the EMC. They must be installed<br />

and operated according to the EMC-advice given in the accompanying documents. In particular medical,<br />

electrical devices may be influenced by portable and mobile RF-communication devices.<br />

The manufacturer guarantees the conformity of the unit with the EMC-requirements only when using<br />

accessories which are listed in the EC declaration of conformity. The usage of other accessories my cause an<br />

increased emission of electromagnetic disturbances or may lead to a reduced electromagnetic immunity.<br />

The unit must not be arranged physically close to other devices or stacked with them. If such an order is<br />

necessary nevertheless, the unit must be observed in order to check it for the intentional operation.<br />

You find more EMC-comments in the chapter “Warnings and Safety Precautions” of this manual as well as<br />

in the Technical Information on the next two pages.<br />

© <strong>gbo</strong> <strong>Medizintechnik</strong> AG 2004 Version 1.3<br />

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4 <strong>HiToP</strong> ® <strong>BodyBeauty</strong> <strong>172</strong><br />

In accordance with the EMC-regulations for medical products we are obliged by law to<br />

provide the following information.<br />

Guidance and manufacturer’s declaration — electromagnetic emissions<br />

The equipment is intended for use in the electromagnetic environment specified below. The customer or<br />

the user of the equipment should assure that it is used in such an environment.<br />

Emissions test Compliance Electromagnetic environment – guidance<br />

RF emissions,<br />

CISPR 11<br />

Group 1 The equipment uses RF energy only for its internal function.<br />

Therefore, its RF emissions are very low and are not likely to cause<br />

RF emissions,<br />

Class B<br />

any interference in nearby electronic equipment.<br />

The equipment is suitable for use in all establishments, including<br />

CISPR 11<br />

domestic establishments and those directly connected to the public<br />

Harmonic emissions,<br />

Class A<br />

low-voltage power supply network that supplies buildings used for<br />

IEC 61000-3-2 (*)<br />

domestic purposes.<br />

Voltage fluctuation/flicker<br />

emissions, IEC 61000-3-3 (*)<br />

Complies<br />

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

Guidance and manufacturer’s declaration — electromagnetic immunity<br />

The equipment is intended for use in the electromagnetic environment specified below. The customer or<br />

the user of the equipment should assure that it is used in such an environment.<br />

Immunity test IEC 60601- test level Compliance level Electromagnetic environment –<br />

guidance<br />

Electrostatic discharge (ESD),<br />

IEC61000-4-2<br />

Electrical fast transient/burst,<br />

IEC 61000-4-4<br />

Surge,<br />

IEC 61000-4-5<br />

Voltage dips, short<br />

interruptions and voltage<br />

variations on power supply<br />

input lines,<br />

IEC 61000-4-11<br />

Power frequency (50/60 Hz)<br />

magnetic field,<br />

IEC 61000-4-8<br />

±6 kV contact<br />

±8 kV air<br />

±2 kV for power supply<br />

lines<br />

±1 kV for input/output<br />

lines<br />

±1 kV differential mode<br />

±2 kV common mode<br />

95% dip)<br />

40% U τ<br />

for 5 cycles<br />

60% dip)<br />

70% U τ<br />

for 25 cycles<br />

30% dip)<br />

5% dip)<br />

±6 kV contact<br />

±8 kV air<br />

±2 kV for power supply<br />

lines<br />

±1 kV for input/output<br />

lines<br />

±1 kV differential mode<br />

±2 kV common mode<br />

95% dip)<br />

40% U τ<br />

for 5 cycles<br />

60% dip)<br />

70% U τ<br />

for 25 cycles<br />

30% dip)<br />

5% dip)<br />

Floors should be wood, concrete or<br />

ceramic tile. If floors are covered with<br />

synthetic material, the relative humidity<br />

should be at least 30 %.<br />

Mains power quality should be that of a<br />

typical commercial or hospital<br />

environment.<br />

Mains power quality should be that of a<br />

typical commercial or hospital<br />

environment.<br />

Mains power quality should be that of a<br />

typical commercial or hospital<br />

environment.<br />

If the user of the equipment requires<br />

continued operation during power mains<br />

interruptions, it is recommended that the<br />

equipment be powered from an<br />

uninterruptible power supply or a<br />

battery.<br />

3 A/m 3 A/m Power frequency magnetic fields should<br />

be at levels characteristic of a typical<br />

location in a typical commercial or<br />

hospital environment.<br />

Note: U τ is the a.c. mains voltage prior to application of the test level.<br />

© <strong>gbo</strong> <strong>Medizintechnik</strong> AG 2004 Version 1.3


<strong>HiToP</strong> ® <strong>BodyBeauty</strong> <strong>172</strong><br />

Guidance and manufacturer’s declaration — electromagnetic immunity<br />

The equipment is intended for use in the electromagnetic environment specified below. The customer or<br />

the user of the equipment should assure that it is used in such an environment.<br />

Immunity test IEC 60601- test level Compliance level Electromagnetic environment –<br />

guidance<br />

Portable and mobile RF communications<br />

equipment should be used no closer to any<br />

part of the equipment, including cables,<br />

than the recommended separation distance<br />

calculated from the equation applicable to<br />

the frequency of the transmitter.<br />

Conducted RF,<br />

IEC 61000-4-6<br />

Radiated RF,<br />

IEC 61000-4-3<br />

3 Vrms 150 kHz to 80 MHz<br />

3 V/m<br />

80 MHz to 2,5 GHz<br />

3 V eff<br />

Recommended separation distance:<br />

d=1,2√P<br />

3V/m d=1,2√P<br />

for 80 MHz to 800 MHz<br />

d=2,3√P<br />

for 800 MHz to 2,5 GHz<br />

Where P is the maximum output power<br />

rating of the transmitter in watts according<br />

to the transmitter manufacturer and d is the<br />

recommended separation distance in<br />

meters (m).<br />

Interference may occur in the vicinity of<br />

equipment marked with the following<br />

symbol:<br />

Recommended separation distances to portable and mobile RF communication equipment<br />

The equipment is intended to be operated in an electromagnetic environment, where radiated RF<br />

interference is controlled. The user can help in avoiding interferences by means of meeting minimum<br />

separation distances between portable and mobile RF communication equipment (transmitters) according<br />

to the maximum output power of the communication equipment.<br />

Rated power of the Separation distance according to the tranmission frequency (m)<br />

transmitter (W) 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2,5 GHz<br />

d=1,2√P<br />

d=1,2√P<br />

d=2,3√P<br />

0,01 0,12 0,12 0,23<br />

0,1 0,38 0,38 0,73<br />

1 1,2 1,2 2,3<br />

10 3,8 3,8 7,3<br />

100 12 12 23<br />

© <strong>gbo</strong> <strong>Medizintechnik</strong> AG 2004 Version 1.3<br />

5


6 <strong>HiToP</strong> ® <strong>BodyBeauty</strong> <strong>172</strong><br />

EC - DECLARATION OF CONFORMITY<br />

Name of manufacturer : <strong>gbo</strong> <strong>Medizintechnik</strong> AG<br />

Address : Kleiststrasse 6<br />

D - 64668 Rimbach<br />

Germany<br />

We hereby declare under our sole responsibility that the product described below conforms in design and<br />

make as well as in the versions delivered to the corresponding safety and protection requirements defined in<br />

the applicable EC regulations.<br />

Harmonized standards have been used for all conformity checks, national standards have not been applied.<br />

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

Type of product : High Tone Power Therapy Device<br />

Label : <strong>HiToP</strong> ® <strong>BodyBeauty</strong> <strong>172</strong> Part-No. 017-0-0055<br />

Options : none<br />

Accessories : Description Part-No.<br />

Rubber electrode 115 x 175 mm ²<br />

017-0-0046<br />

Rubber electrode 80 x 120 mm ²<br />

017-0-0047<br />

Self adhesive electrode 51 x 57 mm² 017-4-0021<br />

Self adhesive electrode 50 x 104 mm² 017-4-0022<br />

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

Conformity assessment<br />

procedure : Annex II of the directive 93/42/EEC<br />

Classification<br />

Name und registration no.<br />

: IIa (according to MDD, appendix IX)<br />

of the notified body : TÜV Product Service in Munich/Germany with the registration no.<br />

0123<br />

Additional information : none<br />

Date : January-1, 2006<br />

Name of persons responsible : Dr. Eberhard Keck<br />

Title/Function : CEO<br />

Signature :<br />

© <strong>gbo</strong> <strong>Medizintechnik</strong> AG 2004 Version 1.3


<strong>HiToP</strong> ® <strong>BodyBeauty</strong> <strong>172</strong><br />

Notations<br />

Times New Roman in type size 11 - descriptions and explanations;<br />

Arial in type size 10 - functions and control keys of the device;<br />

Lucida in type size 10 or 11 - text appears on the display of the device;<br />

[marking] - text appears on the display next to the soft key.<br />

Pictographs<br />

Attention<br />

Warnings which have to be observed by all means !<br />

Attention !<br />

Observe the instructions for use !<br />

!! Note Information which facilitates your work.<br />

Glossary<br />

Stimulation frequency Frequency with which the frequency band is passed in a cyclic way between the<br />

lower and upper cut-off frequency in the SimulFAM ®<br />

X application.<br />

Scan range Range between the upper and lower cut-off frequency. If the lower and upper cutoff<br />

frequency have got the same quarter tone, this range can be indicated in<br />

octaves.<br />

Softkey A softkey is a key with context-sensitive meaning.<br />

© <strong>gbo</strong> <strong>Medizintechnik</strong> AG 2004 Version 1.3<br />

7


8 <strong>HiToP</strong> ® <strong>BodyBeauty</strong> <strong>172</strong><br />

Inhaltsverzeichnis<br />

OVERVIEW 10<br />

1 INTRODUCTION 11<br />

1.1 Intended Use 11<br />

1.2 Operating concept 12<br />

1.2.1 Ergonomic control panel 12<br />

1.2.2 Display 12<br />

1.3 Optical and acoustical user support 12<br />

1.3.1 Optical user support 12<br />

1.3.2 Acoustical user support 12<br />

1.4 View of <strong>HiToP</strong> ® <strong>BodyBeauty</strong> <strong>172</strong> 13<br />

1.5 Short instructions 14<br />

2 START OF OPERATION 15<br />

2.1 Transport and installation 15<br />

2.2 Connection and switch-on 15<br />

2.2.1 Voltage selection and fuses 15<br />

2.3 Settings 16<br />

2.3.1 The Menu 16<br />

2.3.2 Unit settings 16<br />

2.3.3 Basic settings 17<br />

2.3.4 Cable Check 18<br />

2.4 Intensity monitoring 18<br />

2.4.1 Intensity monitoring active 19<br />

2.4.2 Deactivate intensity monitoring 19<br />

3 DESCRIPTION OF FUNCTION 21<br />

3.1 Description of the display contents 21<br />

3.1.1 General view 21<br />

3.1.2 Detail view 22<br />

3.2 Operating notes 22<br />

3.2.1 Intensity knob 22<br />

3.2.2 Softkey 23<br />

3.2.3 Channel keys 23<br />

3.2.4 Modification keys 23<br />

4 THERAPY 24<br />

4.1 Therapy with Vitalization 24<br />

4.2 Therapy with SimulFAM ® X 25<br />

© <strong>gbo</strong> <strong>Medizintechnik</strong> AG 2004 Version 1.3


<strong>HiToP</strong> ® <strong>BodyBeauty</strong> <strong>172</strong><br />

5 ELECTRODES 26<br />

5.1 Electrode positioning 26<br />

5.2 Multiple logitudinal (whole-) body treatments in parallel 27<br />

6 BEHAVIOR IN CASE OF TROUBLES 28<br />

7 MAINTENANCE 29<br />

7.1 Safety controls 29<br />

7.2 Cleaning, disinfection and care 29<br />

7.2.1 Electrode Fleece, Electrode Pockets or Felts 29<br />

8 WARNINGS AND SAFETY PRECAUTIONS 30<br />

9 EXPLANATION OF THE SIGNS USED 31<br />

10 TECHNICAL DATA 32<br />

11 ACCESSORIES 33<br />

© <strong>gbo</strong> <strong>Medizintechnik</strong> AG 2004 Version 1.3<br />

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10 <strong>HiToP</strong> ® <strong>BodyBeauty</strong> <strong>172</strong><br />

Overview<br />

Chapter 1 describes the basic characteristics of the HighTone Therapy device.<br />

Chapter 2 explains the starting and adjustment possibilities of the device.<br />

Chapter 3 describes all functions of the device and their operation.<br />

Chapter 4 explains how to carry out the different therapies.<br />

Chapter 5 provides information concerning the application and use of the electrodes.<br />

Chapter 6 lists the possible failures, their indications and their possible causes.<br />

Chapter 7 refers to safety controls in accordance to the MDD and to routine maintenance.<br />

Chapter 8 lists the possible threats which could occur using the HighTone Therapy device. Apart from<br />

this, information is supplied in order to avoid threats.<br />

Chapter 9 explains the signs used.<br />

Chapter 10 specifies all relevant technical data of the device.<br />

Chapter 11 shows the device’s scope of supply and informs about further accessories indicating the<br />

order number.<br />

© <strong>gbo</strong> <strong>Medizintechnik</strong> AG 2004 Version 1.3


<strong>HiToP</strong> ® <strong>BodyBeauty</strong> <strong>172</strong><br />

1 Introduction<br />

1.1 Intended Use<br />

The <strong>HiToP</strong> ® <strong>BodyBeauty</strong> <strong>172</strong> is a microprocessor-controlled HighTone Therapy device for electrotherapy.<br />

Its application range predestines this device for:<br />

Thus, the <strong>HiToP</strong> ® (HighTone Power) <strong>BodyBeauty</strong> <strong>172</strong> is well suited for:<br />

• muscle relaxation<br />

• muscle training<br />

• muscle stimulation (increase of energy consumption)<br />

• rehabilitation<br />

• lipolysis (decrease of fatty cells in the upper tissue)<br />

• “refreshment treatment” for overall vitalisation.<br />

The use of <strong>HiToP</strong> ® <strong>BodyBeauty</strong> <strong>172</strong> is made easier by programs which automatically set the therapy<br />

frequencies and the therapy time. There are therapy frequencies particularly for gymnastics, muscle training,<br />

muscle relaxation, rehabilitation, lipolysis, edema treatment, fat burning and “refreshment treatment” for<br />

overall vitalisation.<br />

Also patients with varicose veins, metal implants, endoprotheses and open wounds (ulcus cruris) may be<br />

treated.<br />

The HighTone Power Therapy device <strong>HiToP</strong> ® (HighTone Power) provides a therapy with middle<br />

frequency sine waves. The therapy is absolutely free of d.c. components. There are two channels available.<br />

The frequency range used comprehends 3 octaves, the range of 4096 – 32768 Hz. The therapy frequency is<br />

scanned with a defined frequency. This method is called SimulFAM ® for Simultanous Frequency<br />

Amplitude Modulation. In the following, the basic method is divided into two different ones.<br />

SimulFAM ® i<br />

A slow frequency scan of up to three octaves is realized. The minimum amplitude is passed with the<br />

minimum frequency. The maximum amplitude is passed with the maximum frequency. This therapy<br />

activates the metabolism of the body without any effect of nerve- and muscle-stimulation.<br />

SimulFAM ® X<br />

A frequency scan of three octaves is realized. The frequency scan is realized with different speed (0.1 –<br />

200 Hz). This therapy activates the metabolism in the body, thus having an effect of stimulation.<br />

© <strong>gbo</strong> <strong>Medizintechnik</strong> AG 2004 Version 1.3<br />

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12 <strong>HiToP</strong> ® <strong>BodyBeauty</strong> <strong>172</strong><br />

1.2 Operating concept<br />

1.2.1 Ergonomic control panel<br />

The control panel possesses softkeys as function keys. Function keys activate a function of the device. All<br />

keys are easy to feel and have a pressure point<br />

1.2.2 Display<br />

The device is equipped with a high-resolution graphic display (240 x 64 pixel resolution). The parameters<br />

and measuring values of the selected current type are shown there.<br />

1.3 Optical and acoustical user support<br />

1.3.1 Optical user support<br />

Optical user support is given in the form of LED lights incorporated into the keys.<br />

LED Key status<br />

flashing key was selected and remains active<br />

constantly lit key is active<br />

not lit key is not active<br />

Table 1: Optical user support<br />

Furthermore, an optical user support is furnished on the display. A modification, which is just being<br />

changed, is shown inversely.<br />

1.3.2 Acoustical user support<br />

The following table explains about the acoustic signals and their meaning:<br />

Type of signal Cause<br />

Confirmation beep • Admissible pressing of a key.<br />

Information sound • The patient plug is unplugged during operation.<br />

• A limit of voltage or power has been reached.<br />

• When turning the intensity knob without activated channel.<br />

Triad gong • At the end of the faultless automatic check at the start of<br />

operation.<br />

• At the end of therapy.<br />

Table 2: Acoustical user support<br />

© <strong>gbo</strong> <strong>Medizintechnik</strong> AG 2004 Version 1.3


<strong>HiToP</strong> ® <strong>BodyBeauty</strong> <strong>172</strong><br />

1.4 View of <strong>HiToP</strong> ® <strong>BodyBeauty</strong> <strong>172</strong><br />

Channel keys Graphic display Softkeys Bar display<br />

<strong>HiToP</strong> ®<br />

Figure 1: Front view<br />

<strong>172</strong><br />

Figure 2: Device view from the right<br />

Modification keys Intensity knob<br />

Application part<br />

ungrounded,<br />

protection degree BF<br />

II I<br />

Patient cable connections<br />

!<br />

Attention! Observe user<br />

manual!<br />

© <strong>gbo</strong> <strong>Medizintechnik</strong> AG 2004 Version 1.3<br />

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14 <strong>HiToP</strong> ® <strong>BodyBeauty</strong> <strong>172</strong><br />

1.5 Short instructions<br />

1. Connect the device through the mains switch at the back of the device. After that the device carries out<br />

an automatic check of all functions. The faultless automatic check ends with an acoustic signal (triad<br />

gong).<br />

2. Connect the accessories with the according socket on the right side of the device.<br />

3. Apply the electrodes to the patient (see chapter Electrodes).<br />

4. Press the Softkey [Prog] for the desired channel.<br />

5. A list of programs opens up.<br />

6. Move the scroll bar to the desired program with the modification keys.<br />

7. Confirm by pressing the Softkey [load].<br />

8. You quit the list of choice and the selected program is activated.<br />

9. The basic installation of the program is set automatically.<br />

!! Notes<br />

• Within 10 seconds the intensity knob must be turned on or another current type must be<br />

selected, otherwise the inverse presentation of the indication will be turned off. When turning<br />

on the intensity knob you receive the following note:<br />

“Please select channel. Activate the desired channel once again.”<br />

• For the selection of program Vitalisation please proceed as follows:<br />

a. Turn on the intensity knob.<br />

b. The display shows: Confirm tingling sensation with ‚continue‘! f = 4096 Hz<br />

c. Increase the voltage with the intensity knob up to the sensitive threshold. The patient feels<br />

a tingling sensation under one of the electrodes.<br />

d. Confirm the intensity value of the lower setting frequency by pressing the Softkey<br />

[continue].<br />

e. The display shows: Confirm the tingling sensation with ‘continue‘! f = 16384 Hz<br />

f. Increase the voltage with the intensity knob up to the sensitive threshold. The patient feels<br />

a tingling sensation under one of the electrodes.<br />

g. Confirm the intensity value of the upper setting frequency by pressing the Softkey<br />

[continue] and the therapy starts.<br />

10. Increase the current intensity slowly with the Intensity knob, until the desired stimulation takes place<br />

(Exception Program Vitalization, see above).<br />

11. The Detail window is shown automatically and the therapy starts. The bar display SimulFAM ® X<br />

shows the active frequency optically.<br />

12. In case of scanning frequencies the present stimulation frequency is shown.<br />

The frequency values are increased and reduced every second.<br />

13. Within 20 seconds after having activated the Intensity knob, the program returns automatically to the<br />

overview window. Here the frequency and the voltage for the chosen channels are shown for the<br />

activated channels depending on the current program.<br />

14. For the channels that are already activated there is shown [detail view] on the right of the display. These<br />

can be activated by pressing the referring Softkey. In this window depending on the current program<br />

there is shown additionally the intensity and the current. By pressing one of the channel keys you can<br />

return to the overview window.<br />

15. At the end of the therapy the triad gong will sound. The current to the patient will be automatically<br />

reduced.<br />

© <strong>gbo</strong> <strong>Medizintechnik</strong> AG 2004 Version 1.3


<strong>HiToP</strong> ® <strong>BodyBeauty</strong> <strong>172</strong><br />

2 Start of operation<br />

2.1 Transport and installation<br />

The HighTone Power Therapy device is a portable unit. In the base plate there is a carrying handle in the<br />

form of a recessed grip. Each plane surface is appropriate to place the unit. A wall distance of at least 20 cm<br />

has to be observed. The device must not be placed in front of radiators.<br />

The device for HighTone Therapy corresponds to the regulations DIN/VDE 0750, EN 60601-1. It is a device<br />

of protection class I. Within the scope of the MDD the HighTone Power Therapy device belongs to class IIa<br />

(see also chapter 8 Warnings and safety precautions).<br />

Attention<br />

The unit is not designed to be used in non-explosion-proof areas. If it is used in dangerous<br />

areas of anesthesia departments, the possibility of an explosion cannot be excluded.<br />

If the patient and/or the patient cable is directly exposed to a radiator of a medical device for<br />

high frequency heat therapy, damage of the device or a threat to the patient cannot be<br />

excluded. As a rule, a distance of 3 m is sufficient.<br />

2.2 Connection and switch-on<br />

The basic setting of the HighTone Power Therapy device has been set for a supply voltage of 230 V. If<br />

needed, the device can be switched over to the following supply voltages:<br />

• 230 V (standard)<br />

• 115 V<br />

Irrespective of the adjusted mains voltage, the device is appropriate for power frequencies of 48 to 62 Hz.<br />

2.2.1 Voltage selection and fuses<br />

1. Unplug the mains plug.<br />

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

device.<br />

3. The adjusted supply can be seen through the small window of the box.<br />

4. With a screw driver the box can be pulled out of the receiver by the small slot.<br />

5. Take the voltage selector out of the receiver and set the correct mains voltage.<br />

Attention<br />

The mains socket has been sealed with a scotch tape. This is to remember to prove prior to<br />

switch-on, if the adjusted voltage corresponds to the supply voltage of the consulting room.<br />

The scotch tape over the mains socket is easy to remove. Connect the HighTone Power Therapy device with<br />

the mains cable to a grounded power outlet.<br />

The HighTone Power Therapy device is switched on by the mains switch on the back of the device. By this<br />

arrangement erroneous, unintended disconnection of the device during normal operations shall be avoided.<br />

After switching on the device, an automatic check of all functions will be carried out.<br />

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16 <strong>HiToP</strong> ® <strong>BodyBeauty</strong> <strong>172</strong><br />

2.3 Settings<br />

2.3.1 The Menu<br />

You can open the main menu by pressing a Softkey [Menu]. It provides the following submenus:<br />

• Basic settings<br />

• Device settings<br />

• Cable check<br />

Channel I<br />

Channel II<br />

Figure 3: Menu<br />

The basic and device settings are settings that are specific for the unit or the program. These settings should<br />

be implemented during assembly by a medical product advisor or a service technician. Once the HighTone<br />

Therapy device has been switched on and is ready, you can start immediately with the standard settings.<br />

!! Notes<br />

• The menu can be chose with the Softkey [Menu] only if the intensity is “0.0” in all channels and<br />

the patient plug for at least one channel is not plugged in, that is, no therapy is active any more.<br />

• During modification of the settings it is always possible to return with the Softkey [return].<br />

2.3.2 Unit settings<br />

Menu<br />

Basic settings<br />

Unit settings<br />

Cable check<br />

1. Press the Softkey [Menu]. You are in the Menu.<br />

2. Move the scroll bar with the Modification key to Unit settings.<br />

3. Confirm by pressing the Softkey [continue].<br />

4. You are in the menu Unit settings. The menu offers the following options:<br />

• Volume gong<br />

• Volume beeper<br />

• Contrast Display<br />

• Language<br />

5. Move the scroll bar with the Modification keys to the unit setting to be changed.<br />

6. Confirm by pressing the Softkey [continue].<br />

7. Move the cursor or change the value with the Modification keys to the desired value.<br />

8. Confirm by pressing the Softkey [store].<br />

9. Exit the menu Unit settings by pressing the Softkey [return]. On the display the menu appears again.<br />

10. Exit the menu by pressing the Softkey [return]. In the display the overview window appears again.<br />

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Cont.<br />

Softkeys


<strong>HiToP</strong> ® <strong>BodyBeauty</strong> <strong>172</strong><br />

Unit settings Setting possibilities Delivery<br />

Contrast Display 0 - 9 5<br />

Volume of signals 0 - 3 3<br />

Volume of gong 0 - 3 3<br />

Language German<br />

English<br />

Spanish<br />

Italian<br />

French<br />

Russian<br />

Polish<br />

Portuguese<br />

German<br />

Table 3: Unit settings<br />

2.3.3 Basic settings<br />

The basic settings are pre-set after switching on the unit or after selecting a channel.<br />

1. Press a Softkey [Menu]. Your are in the Menu.<br />

2. Move the scroll bar with the Modification keys to Basic settings.<br />

3. Confirm by pressing the Softkey [continue]. You are in the menu Basic settings. The menu offers the<br />

following options:<br />

• Intensity monitoring<br />

• Duration of treatment sub-menu see program list<br />

4. Move the scroll bar with the Modification keys to the Basic setting to be changed.<br />

5. Confirm by pressing the Softkey [continue].<br />

6. Move the cursor or change the value with the Modification keys to the desired value.<br />

7. Confirm by pressing the Softkey [store].<br />

8. Exit the menu Basic settings by pressing the Softkey [return].<br />

9. In the display the menu appears again.<br />

10. Exit the menu by pressing the Softkey [return].<br />

11. In the display the overview window appears again.<br />

Basic settings Setting<br />

possibilities<br />

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17<br />

Standard status<br />

Current monitoring on / off on<br />

treatment time<br />

= basic setting of the treatment time that is pre-set after switching<br />

on the unit or selecting a channel.<br />

vitalisation<br />

lipolysis<br />

electro massage<br />

vibro massage<br />

sport<br />

Table 4: Basic settings<br />

5 – 40 min<br />

5 – 40 min<br />

5 – 40 min<br />

5 – 40 min<br />

5 – 40 min<br />

30 min<br />

30 min<br />

30 min<br />

30 min<br />

15 min


18 <strong>HiToP</strong> ® <strong>BodyBeauty</strong> <strong>172</strong><br />

2.3.4 Cable Check<br />

1. Press the black Menu key.<br />

2. You are in the Main menu.<br />

3. Move the scroll bar with the Modification key to Cable Check.<br />

4. Confirm by pressing the white Softkey [Continue].<br />

5. Proceed as shown in the display:<br />

Please check that nobody is connected to the device! Connect cable (patient cable) to be tested into a<br />

black and a white plug of the distribution panel.<br />

6. Press the white Softkey [Continue].<br />

7. To select a channel, please press one of the keys.<br />

8. Press the white Softkey [Start test].<br />

9. Move and twist the cable at all parts in order to detect a weak connection or disruption.<br />

10. If the cable and all connections are okay, the message OK is displayed after 10 seconds.<br />

11. Otherwise Error is displayed. The patient cable is defective, please replace it.<br />

12. The distribution cable can also be tested:<br />

• Please use a patient cable, proved to be OK.<br />

• Use this cable for testing other distribution cables. If the message Error is displayed, the distribution<br />

cable is damaged and must be replaced.<br />

13. Exit the Menu Cable Check by pressing the black Menu key [Return].<br />

14. On the display the Main menu appears again.<br />

15. Exit the Main menu by pressing the black Menu key [Return].<br />

16. On the display the Overview appears again.<br />

2.4 Intensity monitoring<br />

During the development of the <strong>HiToP</strong> ® <strong>BodyBeauty</strong> <strong>172</strong> we have endeavored not only to offer you a<br />

HighTone Power Therapy device of a new generation with regard to its efficiency and operatability, but also<br />

to set new standards with regard to the patient’s safety.<br />

Intensity increase at open circuits, i.e. no patient is connected to the device:<br />

If the initial voltage is increased at open circuit and no current is measured, the channel will be switched off<br />

for the patient´s safety. An acoustic signal is given and a message will be displayed: Please check that the<br />

electrodes and cables of channel N have good contact.<br />

!! Note<br />

If this message is displayed: Please check that the electrodes and cables of channel N have good<br />

contact, you should check the contact of the electrodes and the cables, resp., prior to setting the<br />

intensity anew.<br />

Abrupt resistance changes in the electrode application can cause problems:<br />

1. Two electrodes touch each other and form a shunt when adjusted upward. If the patient moves during<br />

the therapy, that shunt can open and the patient becomes exposed to an unintended high intensity of<br />

current.<br />

2. The electrodes are shorted-out by a conductive foreign substance. This could be a metallic spectacle<br />

frame in case of tinnitus treatment . If during the treatment that shunt is removed (e.g. by taking off the<br />

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glasses) this abrupt resistance modification also leads to a severe modification of the intensity of<br />

current.<br />

3. It is especially in case of frequently used adhesive electrodes that a weak and therefore highly resistive<br />

contact is caused. If the desired intensity of current is adjusted in this condition and the electrode is<br />

pressed closer during the treatment, e.g. if the patient turns round and lies on the electrode, this can also<br />

lead to a severe increase of the intensity of current.<br />

4. Please observe by all means the notice on the electrode position. (see chapter 5 Electrodes).<br />

2.4.1 Intensity monitoring active<br />

We at <strong>gbo</strong> <strong>Medizintechnik</strong> AG have expanded the device software by a special intensity monitoring routine<br />

in order to get these application problems under control. This safety switching avoids an unintended high<br />

change of the intensity of current and switches off the respective channel in such a case. On the display a<br />

note for the respective channel is shown (in that example: channel 1):<br />

Please check that the<br />

electrodes of channel 1<br />

have good contact.<br />

In that case the therapist can correct the electrode placement and start the therapy again.<br />

2.4.2 Deactivate intensity monitoring<br />

!! Notes<br />

• The intensity monitoring is automatically activated for all channels after each restart of the unit!<br />

The function can be manually deactivated in the Menu Basic settings after starting the unit.<br />

• Deactivate the intensity monitoring only in exceptional cases, e. g. in case of the Big-Tast-<br />

Therapy!<br />

1. Press the black Menu key.<br />

2. You are in the Main menu.<br />

3. Move the scroll bar with the Modification key to Basic settings.<br />

4. Confirm by pressing the white Softkey [Continue].<br />

5. Move the scroll bar with the Modification key to Intensity monitoring.<br />

6. Confirm with the Softkey [Continue].<br />

7. The Menu Intensity monitoring opens another window:<br />

Intensity monitoring<br />

channel I<br />

channel II<br />

8. Move the scroll bar with the Modification key to the channel, of which you want to deactivate the<br />

intensity monitoring.<br />

9. Confirm by pressing the white Softkey [Continue].<br />

10. The Menu Intensity monitoring channel 1 (or 2 – depending on the selection) opens.<br />

11. The device presetting is “on”.<br />

12. Modify it with the Modification key to “off”.<br />

13. Confirm by pressing the white Softkey [Confirm].<br />

14. You will return to the Menu Intensity monitoring channel 1 (or 2 – depending on the selection).<br />

15. If needed here you can select further channels and deactivate them as described in 8. - 13.<br />

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20 <strong>HiToP</strong> ® <strong>BodyBeauty</strong> <strong>172</strong><br />

16. If you want to finish the selection, press the black Menu key three times and you will be in the general<br />

window again.<br />

!! Notes<br />

• The note that the Intensity monitoring is deactivated is shown only in the detail view of the<br />

respective channel.<br />

• The Intensity monitoring for a channel remains deactivated until it is modified manually into “on”<br />

through the Menu Basic settings / Intensity monitoring or will automatically activated for all<br />

channels after each restart !<br />

• The menu (settings, intensity monitoring) can only be selected, if the intensity of all channels is set<br />

to “0.0” and if at least one patient plug is disconnected.<br />

• During the modification of any settings you can return by pressing the Softkey [Return]..<br />

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3 Description of function<br />

3.1 Description of the display contents<br />

Both a general view and a detail view can be shown on the display alternatively. The device recognizes the<br />

number of channels automatically from the distribution cables connected and then displays only those that<br />

are connected. The display area of channels which are not connected remains blank. It is possible to get a<br />

detail view for each of the plugged channels by keystroke.<br />

3.1.1 General view<br />

The general view shows the following from left to right for each of the 2 channels:<br />

• the remaining therapy time,<br />

• the selected program,<br />

• the presently applied voltage,<br />

• Menu or detail view.<br />

remaining treatment<br />

time program<br />

Figure 4: Overview<br />

12:22<br />

10:12<br />

outputvoltage<br />

Vitalization<br />

f=10.585 Hz<br />

Lipolysis<br />

26.7 V<br />

9.5 V<br />

In the General view window each active channel can be chosen for a detailed view. This view is selected by<br />

the referring Softkeys [detail view]. In contrast to the General view in the Detail view shows further<br />

parameters of the current program.<br />

!! Note<br />

You will return to the general view by pressing a Channel key again.<br />

detail view, only if channel<br />

activated, otherwise Menu.<br />

Det.<br />

Men.<br />

Det.<br />

Men<br />

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3.1.2 Detail view<br />

It is possible to get a detail view of each active channel. The selection of this view is done by the Softkeys<br />

[Detail view] allocated to the channels. In contrast to the general view, the detail view shows further<br />

parameters of the type of current.<br />

• Output frequency<br />

• Output voltage<br />

• Output current<br />

• Output power<br />

!! Note<br />

You will return to the general view by pressing a Channel key again.<br />

Figure 5: Detail view<br />

Remaining therapy time<br />

3.2 Operating notes<br />

3.2.1 Intensity knob<br />

Program<br />

12:22<br />

Vitalization<br />

f=10.585 Hz<br />

Output frequency<br />

Output voltage<br />

22.4 V<br />

208 mA<br />

5000 mW<br />

Output current (and<br />

power with vitalization)<br />

The Intensity knob serves for setting the output voltage. It is furnished in the form of a rotor pulse<br />

generator. The current is increased by turning it right (in + direction) and it is reduced by turning it left<br />

(in - direction). The referring numerical value is shown on the display.<br />

!! Notes<br />

• After expiration of therapy time, the current to the patient is automatically switched off and the<br />

intensity knob reverts to “0.0”.<br />

• Before changing over from one current type to another, the Intensity knob has to be set to “0.0”.<br />

Control the current indication on the display.<br />

• The main menu can only be called up with the black menu key, if the intensity of all channels has<br />

been set to “0.0” .<br />

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3.2.2 Softkey<br />

Figure 6: Softkey<br />

3.2.3 Channel keys<br />

Figure 7: Channel keys I and II<br />

3.2.4 Modification keys<br />

Figure 8: Modification keys<br />

A softkey is a key with context-sensitive meaning. The four softkeys on the right<br />

of the display have different functions within different operating steps. The<br />

respective meaning of the key is shown on the display right next to the key.<br />

By means of the channel keys left to the display, the user can select the 2 channels<br />

individually.<br />

The 2 modification keys control the scroll bar / cursor or serve the<br />

setting of values within a menu. The setting of the therapy time is done<br />

herewith.<br />

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24 <strong>HiToP</strong> ® <strong>BodyBeauty</strong> <strong>172</strong><br />

4 Therapy<br />

Please observe the instructions on the electrode application. The maximum output per channel is 5000 mW.<br />

If this value has been achieved, no further increase of intensity is possible.<br />

4.1 Therapy with Vitalization<br />

Figure 9: Main View<br />

60:00<br />

60:00<br />

Vitalization<br />

Lipolysis<br />

0.0 V<br />

0.0 V<br />

Prog.<br />

Prog.<br />

1. Select channel I or II with the Channel key. The selected channel is shown inversely.<br />

2. Press the Softkey [Prog].<br />

3. Choose the program Vitalization from the list.<br />

4. The display shows: Confirm tingling sensation with ‘continue’! f = 4096 Hz<br />

5. Increase with the Intensity knob the voltage of the lower setting frequency (f = 4096 Hz) up to the<br />

stimulus threshold. Confirm by pressing the Softkey [continue].<br />

6. The display shows: Confirm tingling sensation with ‘continue’! f = 16384 Hz<br />

7. Increase with the Intensity knob the voltage of the upper setting frequency (f = 16384 Hz) up to the<br />

stimulus threshold. Confirm by pressing the Softkey [continue].<br />

8. The therapy starts and the frequency and voltage are shown in the general view. The frequency values<br />

are changed every second.<br />

9. In the display on the right [detail view] is shown. Activate this by pressing the respective softkey. In this<br />

window the current and actual power are shown additionally.<br />

10. You return to the general window by pressing one of the channel keys.<br />

11. At the end of the therapy the triad gong sounds and the patient current is reduced automatically.<br />

12:22<br />

Vitalization<br />

f=10.585 Hz<br />

22.4 V<br />

208 mA<br />

5000 mW<br />

Figure 10: Detail View Vitalization<br />

!! Note<br />

The amplitude values follow the threshold curve determined before.<br />

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4.2 Therapy with SimulFAM ® X<br />

1. Select channel I or II with the Channel key.<br />

2. The selected channel is shown inversely.<br />

3. Press the Softkey [Prog].<br />

4. Choose the desired application field with one of the two softkeys.<br />

5. Turn the intensity knob slowly, until the required stimulation effect takes place.<br />

6. The detail window is shown automatically and the therapy starts.<br />

7. Die bar display Lipolysis displays the current frequency optically.<br />

8. Within 20 seconds after having activated the intensity knob, the program returns to the overview<br />

window.<br />

9. In the general view window the voltage of the already activated channels is displayed.<br />

10. For the already activated channels on the right of the display there can be seen [detail view]. This must<br />

be activated by pressing the referring softkey. In this window there is shown additionally the current. By<br />

pressing one of the channel keys you can return to the overview window.<br />

11. At the end of the therapy the triad gong sounds and the patient current is reduced automatically, the<br />

intensity is automatically set to ”0.0”.<br />

!! Note<br />

The detail view additionally displays the current.<br />

12:22<br />

Lipolysis<br />

Figure 11: Detail view with SimulFAM ® X for Lipolysis<br />

10.7 V<br />

21 mA<br />

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5 Electrodes<br />

For the treatments of large areas preferably large conductive or adhesive electrodes are recommended. For<br />

sensitive parts of the head small adhesive electrodes should be used. The electrodes must be plugged in to<br />

the unit through a patient cable which is connected to the distribution cable..<br />

The electrode size depends on the current to be applied. Under small electrodes the current is more<br />

concentrated and more localised than under large electrodes.<br />

Electrode Area Maximum current<br />

Conductive rubber electrode 80 mm x 120 mmm 95 cm 2<br />

190 mA<br />

Conductive rubber electrode 115 mm x 175 mm 200 cm 2<br />

300 mA<br />

Self adhesive electrode 51 mm x 57 mm (2” x 2 ¼”) 29 cm 2<br />

58 mA<br />

Self adhesive electrode 51 mm x 104 mm (2” x 4”) 52 cm 2<br />

Table 5: Maximum currents for electrodes<br />

104 mA<br />

5.1 Electrode positioning<br />

The positioning of the patient is very important. The therapy shall always be carried out in a comfortable<br />

and relaxed position. The joints shall be located in an angular position, so that they are placed in a midposition,<br />

from which both the flexor as well as the extensor muscles can be stimulated.<br />

In general, the preparation and application of the electrodes is carried out as follows:<br />

1. Connect the electrodes to the patient cable.<br />

2. Connect the patient cable to the distribution cable.<br />

3. Plug in the patient plug of the distribution cable to the referring channel socket of the unit.<br />

4. Wet the conductive rubber electrodes with Aloe contact spray to avoid current sensations on the skin.<br />

5. If you want to use the macroporous intermediate layers or fleece pockets, they must be thoroughly<br />

washed under running water.<br />

6. Apply the electrodes to the patient.<br />

7. Apply the holding strap in a way that the electrode fits completely.<br />

Attention<br />

• Do not apply the electrodes on skin injuries. Even minor abrasions can cause a burning to<br />

the patient. Herewith the intensity of the current can be erroneously judged by the<br />

patient. If this cannot be avoided, apply zinc ointment or vaseline to cover the affected<br />

parts of the skin.<br />

• The electrodes must adhere completely to the skin in order to avoid excessive local<br />

current density. Otherwise there can occur erythemas, and sometimes even burns.<br />

• It is recommended not to exceed the current density of 2 mA/cm 2 for all electrodes.<br />

• During the therapy the patient must take off jewelry and glasses.<br />

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5.2 Multiple logitudinal (whole-) body treatments in parallel<br />

As a rule, in whole-body treatment the longitudinal current flow is realized with two pairs of electrodes,<br />

applied on the hands and feet each.<br />

Principally – independent of the physiological effect of such a therapy – with the two channels of<br />

<strong>HiToP</strong> ® <strong>BodyBeauty</strong> <strong>172</strong> also multiple parallel, overlapping longitudinal current flows can be realized.<br />

Here, due to physical principles, on the devices side it cannot be excluded that the patient experiences<br />

current sensations when adding further channels. Thus, please notice:<br />

!! Note If a second electric circuit is added in parallel to the first longitudinal body treatment,<br />

which is overlapping the first circuit for a large area of activity, the total resistance in<br />

the first circuit is reduced suddenly at the moment of turning on the second circuit. This<br />

rapid change in resistance causes a sudden current increase, which in the end may lead<br />

to a current sensation or – with acivated current monitoring - to cutting off of one<br />

channel. This can be avoided in the following way:<br />

• Activate first the circuit, which passes the smaller part of the body, and only after<br />

that the whole body treatment.<br />

This note is only applicable for current circuits that overlap in a significantly<br />

large area. Of cause local therapies of small body regions, e.g. the knee, during a<br />

whole-body treatment are not concerned by this.<br />

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6 Behavior in case of troubles<br />

The following failures will be indicated optically and acoustically by the HighTone Therapy device (see<br />

chapter Optical and acoustical user support). Most of them can be overcome if you proceed as indicated on<br />

the display. In general:<br />

1. The device is protected against faulty use for a large extent. That means: The device does not carry out<br />

a function or modification erroneously entered through keystroke, intensity knob or modification key.<br />

2. The acoustic signal will sound.<br />

3. The display shows a failure.<br />

4. If the operator does not react to the respective notes, the previous correct status will be restored after a<br />

timeout.<br />

Failures:<br />

Failure alarm:<br />

♦ There is a problem in the power supply.<br />

Suggestions:<br />

− Switch off and on again.<br />

− If the failure occurs again, the device is out of function. Please contact a service agent authorized by<br />

the manufacturer.<br />

Application errors:<br />

Failure:<br />

♦ Wrong electrode in the channel...!<br />

Suggestion:<br />

− Check the allocation of the cables to the channels.<br />

Failures:<br />

♦ Please check that the electrodes of channel N have good contact.<br />

♦ Short circuit in channel . . .!<br />

Suggestion:<br />

− This means that the patient circuit has been interrupted. Check the electrodes, cables and connections.<br />

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7 Maintenance<br />

Functionality, reliability and safety characteristics of HighTone Therapy devices are only guaranteed if<br />

properly used in accordance with the operating instructions. Safety control, maintenance, repair and<br />

modifications shall be carried out by the manufacturer or the service agents authorized by him. In case of a<br />

failure, parts which influence the safety of the device shall be replaced only by original spare parts of the<br />

manufacturer. The electric installation shall be carried out in accordance with the requirements of VDE/IEC.<br />

The device does not contain any parts which need maintenance work done by the user.<br />

7.1 Safety controls<br />

The device is subject to the provisions of the MDD. The safety controls have to be carried out on the basis<br />

of this law. Thereby, the operator regulation has to be especially observed.<br />

Irrespective of the legal rules or beyond the scope of the MDD, it is recommended to have the device<br />

checked by the manufacturer or by a service agency authorized by him at 12-months intervals.<br />

The check shall consist of at least the following:<br />

• Electrical safety check in accordance with the check plan of the manufacturer,<br />

• Check of the device in respect of external integrity,<br />

• Check of all display and operating elements in respect of damage,<br />

• Check of all inscriptions in respect of legibility.<br />

7.2 Cleaning, disinfection and care<br />

For cleaning and disinfection of the device and its accessories there should not be used any agents<br />

containing higher portions of phenol derivates, alcohol, compounds of chlorine or peracetic acid. It is<br />

recommended to use disinfectants on aldehyde basis.<br />

The device is not suited for heat sterilization or for sterilization with gases.<br />

Attention<br />

Before cleaning or disinfection unplug the mains plug out of the socket!<br />

The device is suited for wiping disinfection. It has to be observed that no liquids enter the device. Never<br />

shall the plug or socket get wet. For cleaning or disinfection the device must not be dizzled.<br />

7.2.1 Electrode Fleece, Electrode Pockets or Felts<br />

1. Put the material into neutral soap-suds and rub it slightly. If necessary, disinfect with disinfectant<br />

solution, but do not put it into it.<br />

2. Leave the parts over the night in the neutral soap-suds or tap water.<br />

3. Take them out, and wash them several times thoroughly out under cold or warm running water.<br />

4. Let them drop, but do not wring them out.<br />

© <strong>gbo</strong> <strong>Medizintechnik</strong> AG 2004 Version 1.3<br />

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30 <strong>HiToP</strong> ® <strong>BodyBeauty</strong> <strong>172</strong><br />

8 Warnings and safety precautions<br />

Attention !<br />

• In case of patients with implanted electronic device please carry out HighTone Therapy<br />

only after having checked whether there is any risk.<br />

• Pieces of jewellery and glasses have to be taken off during the treatment.<br />

• Turn off cellular phones and radiophones or place them in a distance of 3 m from the<br />

device.<br />

• Cardiac pacemakers can extremely be disturbed. In these cases the therapy should be<br />

carried out only under continuous pulse and ECG control.<br />

• If the patient and/or the patient cable is in direct range of high frequency, shortwave or<br />

microwave therapeutic device, a damage to the device or an injury to the patient cannot be<br />

excluded. Please keep a distance of at least 3 m.<br />

• A simultaneous connection of the patient to a high-frequency surgery device can lead to<br />

burns under the electrical stimulus electrodes.<br />

• The device is not designed for use in non-explosion-proof areas. If it is used in dangerous<br />

anesthesia areas, an explosion cannot be excluded.<br />

• It is recommended not to exceed the current density of 2 mA/cm 2 for all electrodes.<br />

• The electrodes must adhere completely to the skin in order to avoid excessive local<br />

current density. Otherwise there can occur erythemas, and sometimes even burns.<br />

• In case of any visible failures please contact immediately <strong>gbo</strong> <strong>Medizintechnik</strong> AG or one<br />

of the service agencies authorized by <strong>gbo</strong> <strong>Medizintechnik</strong> AG.<br />

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<strong>HiToP</strong> ® <strong>BodyBeauty</strong> <strong>172</strong><br />

9 Explanation of the signs used<br />

0123 CE Conformity sign<br />

Attention !<br />

Observe the instructions for use !<br />

Application part ungrounded, protection degree Type BF<br />

This product complies with WEEE Directive 2002/96/EG<br />

(waste electrical and electronic equipment). Separate<br />

collection for electrical and electronic equipment.<br />

© <strong>gbo</strong> <strong>Medizintechnik</strong> AG 2004 Version 1.3<br />

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32 <strong>HiToP</strong> ® <strong>BodyBeauty</strong> <strong>172</strong><br />

10 Technical data<br />

Mains voltage and frequency: 115, 230 V<br />

48 - 62 Hz<br />

Current consumption: max. 2 A @ 120 V / 60 Hz<br />

Mains fuses: 3,15 AT<br />

Output current (per channel): max. 300 mA<br />

Output voltage (per channel): max. 70 V eff.<br />

Output power: max. 5000 mW<br />

Admissible load impedance: 30 Ω ...5 kΩ<br />

MDD device class: IIa<br />

Safety class: I<br />

Protection degree: BF<br />

Protection against ingress of water: IP X1<br />

Dimensions: max. 12 cm x 27,5 cm x 32 cm (H x D x W)<br />

Weight: max. 4 kg without accessories<br />

Color: white RAL 9002<br />

Display: LCD backlighted, 240 x 64 dots full graphic<br />

Environmental conditions: Operation of Temperature range +10 °C ... +40 °C<br />

the device: Relative humidity 30 ... 75 %<br />

Transport Temperature range +5 °C ... +50 °C<br />

and storage : Relative humidity < 90 %, none condensing<br />

Current types: Sinusoidal currents of 4096 - 32768 Hz<br />

Modulation frequency currents of 0,1 Hz - 200 Hz<br />

Max. Output voltage (per channel) 100 Vpeak<br />

<strong>gbo</strong> <strong>Medizintechnik</strong> AG reserves the right to modify the design and spezification without prior notice.<br />

© <strong>gbo</strong> <strong>Medizintechnik</strong> AG 2004 Version 1.3


<strong>HiToP</strong> ® <strong>BodyBeauty</strong> <strong>172</strong><br />

11 Accessories<br />

Article Article number<br />

<strong>HiToP</strong> ®<br />

<strong>BodyBeauty</strong><br />

<strong>172</strong><br />

Extent of<br />

supply<br />

2 Distribution cable with color coding, 150 cm<br />

2 Set of patient cables with color coding (6 cables of 100 cm each)<br />

8 Conductive rubber electrode 115 mm x 175 mm<br />

2 Conductive rubber electrode 80 mm x 120 mm<br />

10 Elastic tape with closure (velcro) 70 cm<br />

1 Aloe Vera contact spray 473 ml bottle<br />

1 User manual<br />

017-0-0020<br />

Distribution cable I (red), 150 cm 017-0-0030<br />

Distribution cable II (green), 150 cm 017-0-0031<br />

Set of patient cables I (red) (6 cables of 100 cm each) 017-0-0034<br />

Set of patient cables II (green) (6 cables of 100 cm each) 017-0-0035<br />

Cable clip (5 pieces) 017-0-0025<br />

Conductive rubber electrode 115 x 175 (package of 2) 017-0-0046<br />

Conductive rubber electrode 80 x 120 (package of 2) 017-0-0047<br />

Fleece pockets for conductive rubber electrode 80x120 (package of 10 pieces) 45-38-203 EH 725<br />

Elastic tape with velcro closure (2 pieces) 011-0-0033<br />

Aloe Vera contact spray 473 ml bottle 002-2-0073<br />

Self adhesive electrodes 51 mm x 57 mm (2” x 2¼ “), (pack of 4) 017-4-0021<br />

Self adhesive electrodes 51 mm x 104 mm (2” x 4 “), (pack of 4) 017-4-0022<br />

Cervical roll 50 cm x 25 cm 12 cm 017-0-0051<br />

Special foam cushion 28 cm x 38 cm x 9,5 cm 017-0-0052<br />

Leg cube 017-0-0053<br />

Vein cushion 017-0-0054<br />

© <strong>gbo</strong> <strong>Medizintechnik</strong> AG 2004 Version 1.3<br />

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34 <strong>HiToP</strong> ® <strong>BodyBeauty</strong> <strong>172</strong><br />

Index<br />

Acoustical user support<br />

Confirmation beep 12<br />

Information sound 12<br />

triad gong 12<br />

Assembly of the device 15<br />

Attention 15, 26, 29, 30<br />

Channel keys 23<br />

A<br />

C<br />

D<br />

Detail View 21<br />

Device<br />

cleaning, disinfection and care 29<br />

Connection and switch-on 15<br />

switch-on 15<br />

Electrode positioning 26<br />

elektrode fleece 29<br />

Function keys 12<br />

General View 21<br />

Graphic display 12<br />

Keys<br />

E<br />

F<br />

G<br />

K<br />

Modification keys 23<br />

LED 12<br />

Main menu<br />

Basic settings 16<br />

Device settings 16<br />

Program patient unit 16<br />

Mains voltage 15<br />

Maintenance 29<br />

Modification<br />

inverse display 12<br />

modification keys 23<br />

© <strong>gbo</strong> <strong>Medizintechnik</strong> AG 2004 Version 1.3<br />

L<br />

M<br />

N<br />

Notes 14<br />

!! Note 18, 19, 20, 21, 22, 27<br />

Safety controls 29<br />

SimulFAM ® i 11<br />

SimulFAM ® X 11<br />

Softkey 23<br />

Supply change-over 15<br />

Transport of the device 15<br />

Warnings 15, 30<br />

S<br />

T<br />

W


<strong>HiToP</strong> ® <strong>BodyBeauty</strong> <strong>172</strong><br />

Appendix A Programs<br />

The new programs of the <strong>HiToP</strong> <strong>172</strong> are pre-programmed sequences of treatments that are designed to<br />

achieve well defined effects for the customer. The user of the <strong>HiToP</strong> can chose between the Program menu<br />

or the Indication menu by selecting the corresponding menu in the device settings. The different programs<br />

can typically be used with one application of the electrodes, i.e. it is not necessary to change electrode<br />

application as the program changes from one treatment to the next.<br />

The following is a brief description of the different programs and their typical use.<br />

Vitalization<br />

Vitalization consists of SimulFAM ® i only and is typically applied as the whole-body treatment.<br />

The program length is pre-set to 30 minutes but can be changed by the user.<br />

Lipolysis<br />

Lipolysis is the body’s own process of freeing fatty cells from the tissue and making them accessible as<br />

energy carriers for the body to burn. This Lipolysis can be stimulated by HighTone Therapy. The<br />

scientifically proven frequency for maximum stimulation of lipolysis is 3 Hz.<br />

In order to avoid adaptation of the body and based on practical experience our Lipolysis program uses a<br />

frequency sweep from 2.5 – 3.5 Hz. The length of the treatment is preset to 30 minutes but can be changed<br />

by the user.<br />

As this program will only free but not burn the freed fatty cells it is recommended to follow it up with<br />

physical exercise.<br />

The program length is pre-set to 30 minutes but can be changed by the user.<br />

Cellulite<br />

The cellulite treatment combines 10 minutes of lipolysis with 5 minutes of a frequency sweep from 10 –<br />

20 Hz. This sweep will result in a vasoconstriction (10 Hz), pressing blood out of the area, and strong<br />

muscle stimulation (20 Hz), burning the freed fatty cells.<br />

The program is of a fixed length of 30 minutes and the above described sequence is carried out twice.<br />

Fatburning<br />

This program focuses on the reduction of fatty cells. Therefor 80% of the treatment time is used for<br />

Lipolysis. The rest of the time a frequency sweep of 10 – 30 Hz is applied, giving some vasoconstriction but<br />

mainly muscle work in order to burn the freed fatty cells.<br />

The program is of fixed length 30 minutes of 3 cycles with 8 minutes Lipolysis and 2 minutes 10 – 30 Hz.<br />

© <strong>gbo</strong> <strong>Medizintechnik</strong> AG 2004 Version 1.3<br />

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36 <strong>HiToP</strong> ® <strong>BodyBeauty</strong> <strong>172</strong><br />

Body Shaping<br />

Goal of this program is to bring the body into a good shape by reduction of fatty cells on one side and<br />

muscle build up on the other side. Therefor we have evenly combined Lipolysis treatment with a efficient<br />

training of the muscles with SimulFAM ® X frequencies between 20 and 30 Hz.<br />

Important for a effective muscle training is a strong contraction. To achieve this the intensity is increased<br />

during the muscle stimulation period. To give the muscle time to relax, pauses are inserted corresponding to<br />

the Sport program.<br />

The program is of fixed length 30 minutes of 2 cycles. Each cycle contains 5 minutes Lipolysis, 5 minutes<br />

muscle work and 5 minutes relaxation of the muscles with 150 – 200 Hz.<br />

Electro-Massage<br />

To achieve a relaxing and comforting loosening of a muscle or muscle group we can apply a frequency<br />

sweep of 0.5 to 3 Hz. This corresponds to the rhythm of a manual massage and is therefor called Electromassage.<br />

The program length is pre-set to 30 minutes but can be changed by the user.<br />

Shaking-Massage<br />

To achieve a relaxing and comforting loosening of a muscle or muscle group we can apply a frequency<br />

sweep of 3 - 10 Hz. This will result in a vibration or shaking of the muscle and is therefor called Shakingmassage.<br />

The program length is pre-set to 30 minutes but can be changed by the user.<br />

Sport<br />

This is strong muscle training pure. The muscle is being brought to a strong tetanic contraction using<br />

SimulFAM ® X frequencies between 20 and 30 Hz. The intensity should be clearly above the motoric<br />

threshold to ensure a strong contraction.<br />

In order to let the muscle have the necessary relaxation pauses the training follows the cycle 5 s rise time,<br />

5 s holding time (contraction) and 20 s pause.<br />

A important innovation that <strong>gbo</strong> HighTone Therapy adds to the muscle training is that we can use a subthreshold<br />

32 kHz current (i.e. the user does not feel it) during the pauses to alleviate the metabolism and<br />

thereby greatly improve the muscles ability to be supplied with new nutrients and to get rid of waste<br />

products. This allows us to shorten the pause times and to achieve a much more efficient training effect.<br />

The length of the program is pre-set to 15 minutes but can be changed by the user.<br />

© <strong>gbo</strong> <strong>Medizintechnik</strong> AG 2004 Version 1.3


<strong>HiToP</strong> ® <strong>BodyBeauty</strong> <strong>172</strong><br />

Program Step 1 Step 2 Step 3<br />

Vitalization SimulFAM ® i 30 minutes pre-set<br />

Lipolysis 2,5 – 3,5 Hz 30 minutes pre-set<br />

Cellulite 2,5 – 3,5 Hz<br />

10 min<br />

Fatburning 2,5 – 3,5 Hz<br />

8 min<br />

Bodyshaping 2,5 – 3,5 Hz<br />

5 min<br />

Electro-Massage 1,5 Hz *<br />

adjustment<br />

Shaking-<br />

Massage<br />

3 – 10 Hz<br />

Sport 20 Hz<br />

5s /5s /20s<br />

* Adjustment phase 20 seconds<br />

10 – 20 Hz<br />

5 min<br />

10 - 30 HZ<br />

2 min<br />

20 – 30 Hz<br />

5/5/20 s<br />

5 min<br />

0,5 – 3 Hz<br />

150 – 200 Hz<br />

5 min<br />

2 x 15 min = 30 min<br />

fix<br />

3 x 10 min = 30 min<br />

fix<br />

2 x 15 min = 30 min<br />

fix<br />

30 minutes pre-set<br />

30 minutes pre-set<br />

15 minutes pre-set<br />

© <strong>gbo</strong> <strong>Medizintechnik</strong> AG 2004 Version 1.3<br />

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38 <strong>HiToP</strong> ® <strong>BodyBeauty</strong> <strong>172</strong><br />

Correction sheet<br />

<strong>gbo</strong> <strong>Medizintechnik</strong> AG<br />

- Documentation -<br />

Kleiststrasse 6<br />

D-64668 Rimbach<br />

Please indicate the following faults and/or suggestions to the present documentation:<br />

Page Line Faulty text Correct text<br />

(If needed, please attach additional sheet.)<br />

Address:<br />

Art.No. 017-7-0085<br />

© <strong>gbo</strong> <strong>Medizintechnik</strong> AG 2004 Version 1.3

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